6-month Supplementation Research Articles

Amino acid supplementation in l-dopa treated Parkinson's disease patients

The correlation between Parkinson disease and malnutrition is well established, however a protein-restricted diet is usually prescribed because of potentially negative interactions between dietary amino acids and l-dopa pharmacokinetics. This strategy could increase the risk of further nutritional deficits. A monocentric, prospective, randomized, double-blind pilot study was performed on two groups of Parkinson-affected, protein-restricted, patients: Intervention (n = 7; amino acid supplementation twice daily) and Placebo (n = 7; placebo supplementation twice daily). At enrolment, after 3- and 6-month supplementation, neurological evaluations (UPDRS III, Hoenh-Yahr scale, l-dopa equivalent dose assessment) were performed and blood sample was collected to define insulin sensitivity (QUICKI index) and oxidative stress (oxidized and reduced glutathione). Repeated measure ANCOVA was applied to define time effect and time × treatment interaction. Participants were comparable at baseline for all assessed parameters. Neurological outcomes and l-dopa requirement were comparable in both group after 6-month of supplementation, without time × treatment interaction. The decrease in insulin sensitivity, as assessed by QUICKI index, observed after 6 months in both groups, was greater in Placebo than in Intervention (time effect p < 0.001; time × treatment interaction p = 0.01). Moreover, despite no changes in total erythrocyte glutathione concentrations, oxidized glutathione levels decreased by 28 ± 17% in the Intervention while increased by 55 ± 38% in Placebo (time effect p = 0.05; time × treatment interaction p = 0.05), after 6-month supplementation. Amino acid supplementation, assumed with shrewd temporal distribution, did not show detrimental effects on neurological and pharmacological control in protein-restricted Parkinson-affected patients, chronically treated with l-dopa. Furthermore, daily amino acid supplementation partially counteracted insulin resistance development and the loss in antioxidant availability.

Daidzein and genistein fail to improve glycemic control and insulin sensitivity in Chinese women with impaired glucose regulation: A double-blind, randomized, placebo-controlled trial.

This randomized, double-blind, and placebo-controlled trial evaluated the effect of isolated daidzein and genistein on glycemic control and insulin sensitivity in 165 Chinese women aged 30-70 with impaired glucose regulation (IGR). Participants were randomly assigned to one of three groups with a daily dose of 10 g of soy protein plus (i) no addition, (ii) 50 mg of daidzein, or (iii) 50 mg of genistein for 24 wk. Fasting glucose (FG), insulin, and glycosylated hemoglobin (HbA1c ), and glucose concentrations at 30, 60, 120, and 180 min and insulin concentrations at 30, 60, and 120 min after an oral 75-g glucose tolerance test were assessed at baseline and at 12 and 24 wk postintervention. a total of 158 and 151 subjects completed the measures at wk 12 and 24, respectively. There were no significant differences in the changes (%) of FG and the 2-h glucose, HbA1c , fasting, and 2-h insulin or the area under the curve of glucose and insulin between the three treatment groups at wk 12 or 24 (all p > 0.05). Neither isolated daidzein nor genistein has a significant effect on glycemic control and insulin sensitivity in Chinese women with IGR over a 6-month supplementation period.

Recruitment and retention of urban schoolchildren into a randomized double-blind vitamin D supplementation trial.

While rarely used for supplementation trials in the United States, schools present a practical alternative to a clinical setting. We describe the successful recruitment and retention of urban schoolchildren into a 6-month randomized, double-blind vitamin D3 supplementation trial. Boston-area urban schoolchildren, aged 8-15 years, were recruited in 2011-2012 through classroom and auditorium presentations. Informed consent forms in five languages were sent home to parents. Retention methods included regular telephone calls and gift cards for completed study visits. In total, 691 schoolchildren enrolled. Their mean (standard deviation) age was 11.7 (1.4) years; 59% were racial/ethnic minorities and 68% qualified for free or reduced-price school meals. Multi-level, culturally sensitive, creative approaches contributed to success in recruitment and retention. Of 691 participants, 81% completed the 6-month intervention period. Reasons for attrition included missed appointments and fear of a blood draw. More children from households with higher incomes were retained than those from households with lower incomes (85% vs 79%, respectively, P = 0.04). The need for three fasting blood draws over the 6-month supplementation period was a limiting factor in the recruitment and retention of children in this study. Recruitment of urban children into a school-based randomized controlled trial represents a feasible approach for a supplementation study. Particular attention to children of lower socioeconomic status may enhance participation and retention when conducting intervention studies among diverse populations.

Paricalcitol for secondary hyperparathyroidism in renal transplantation.

Secondary hyperparathyroidism contributes to post-transplant CKD mineral and bone disorder. Paricalcitol, a selective vitamin D receptor activator, decreased serum parathyroid hormone levels and proteinuria in patients with secondary hyperparathyroidism. This single-center, prospective, randomized, crossover, open-label study compared the effect of 6-month treatment with paricalcitol (1 μg/d for 3 months and then uptitrated to 2 µg/d if tolerated) or nonparicalcitol therapy on serum parathyroid hormone levels (primary outcome), mineral metabolism, and proteinuria in 43 consenting recipients of renal transplants with secondary hyperparathyroidism. Participants were randomized 1:1 according to a computer-generated sequence. Compared with baseline, median (interquartile range) serum parathyroid hormone levels significantly declined on paricalcitol from 115.6 (94.8-152.0) to 63.3 (52.0-79.7) pg/ml (P<0.001) but not on nonparicalcitol therapy. At 6 months, levels significantly differed between treatments (P<0.001 by analysis of covariance). Serum bone-specific alkaline phosphatase and osteocalcin decreased on paricalcitol therapy only and significantly differed between treatments at 6 months (P<0.001 for all comparisons). At 6 months, urinary deoxypyridinoline-to-creatinine ratio and 24-hour proteinuria level decreased only on paricalcitol (P<0.05). L3 and L4 vertebral mineral bone density, assessed by dual-energy x-ray absorption, significantly improved with paricalcitol at 6 months (P<0.05 for both densities). Paricalcitol was well tolerated. Overall, 6-month paricalcitol supplementation reduced parathyroid hormone levels and proteinuria, attenuated bone remodeling and mineral loss, and reduced eGFR in renal transplant recipients with secondary hyperparathyroidism. Long-term studies are needed to monitor directly measured GFR, ensure that the bone remodeling and mineral effects are sustained, and determine if the reduction in proteinuria improves renal and cardiovascular outcomes.

Low Prostate Concentration of Lycopene Is Associated with Development of Prostate Cancer in Patients with High-Grade Prostatic Intraepithelial Neoplasia

Prostate cancer (PC) is a frequent male malignancy and represents the second most diagnosed cancer in men. Since pre-cancerous lesions, i.e., the high-grade prostatic intraepithelial neoplasia (HGPIN), can be detected years before progression to PC, early diagnosis and chemoprevention are targeted strategies to reduce PC rates. Animal studies have shown that lycopene, a carotenoid contained in tomatoes, is a promising candidate for the chemoprevention of PC. However, its efficacy in humans remains controversial. The present study aimed to investigate the relevance of plasma and prostate concentration of lycopene after a lycopene-enriched diet in patients diagnosed with HGPIN. Thirty-two patients diagnosed with HGPIN were administered a lycopene-enriched diet (20–25 mg/day of lycopene; through 30 g/day of triple concentrated tomato paste) for 6 months. A 6-month follow-up prostate biopsy assessed progression to PC. Patients were classified into three groups according to the histopathological features of the 6-month follow-up biopsy results: prostatitis; HGPIN and PC. PSA and plasma lycopene levels were measured before and after the dietary lycopene supplementation. Prostatic lycopene concentration was only assessed after the supplementation diet. Only prostatic lycopene concentration showed significant differences between the three groups (p = 0.03). Prostatic lycopene concentration below a 1 ng/mg threshold was associated with PC at 6-month follow-up biopsy (p = 0.003). We observed no overall benefits from a 6-month lycopene supplementation, as the rate of HGPIN progression to PC in our population (9/32, 28%) was similar to rates reported in the literature. Baseline PSA levels also showed no significant changes after a lycopene-enriched diet. Our findings point to prostatic lycopene concentration as a promising biomarker of PC. Further prospective longitudinal studies are needed to assess the prognostic role of prostatic lycopene in PC.

Age and sex differences in the incorporation of EPA and DHA into plasma fractions, cells and adipose tissue in humans

The aim of the present study was to determine whether age and sex influence both the status and incorporation of EPA and DHA into blood plasma, cells and tissues. The study was a double-blind, randomised, controlled intervention trial, providing EPA plus DHA equivalent to 0, 1, 2 or 4 portions of oily fish per week for 12 months. The participants were stratified by age and sex. A linear regression model was used to analyse baseline outcomes, with covariates for age or sex groups and by adjusting for BMI. The change in outcomes from baseline to 12 months was analysed with additional adjustment for treatment and average compliance. Fatty acid profiles in plasma phosphatidylcholine, cholesteryl esters, NEFA and TAG, mononuclear cells (MNC), erythrocyte membranes, platelets, buccal cells (BU) and adipose tissue (AT) were determined. At baseline, EPA concentrations in plasma NEFA and DHA concentrations in MNC, BU and AT were higher in females than in males (all P<0·05). The concentrations of EPA in AT (P=0·003) and those of DHA in plasma TAG (P<0·01) and AT (P<0·001) were higher with increasing age. Following 12-month supplementation with EPA plus DHA, adjusted mean difference for change in EPA concentrations in plasma TAG was significantly higher in females than in males (P<0·05) and was greater with increasing age (P=0·02). Adjusted mean difference for change in DHA concentrations in AT was significantly smaller with increasing age (P=0·02). Although small differences in incorporation with age and sex were identified, these were not of sufficient magnitude to warrant a move away from population-level diet recommendations for n-3 PUFA.

Lutein Supplementation over a One-Year Period in Early AMD Might Have a Mild Beneficial Effect on Visual Acuity: The CLEAR Study

We investigated the effect of daily supplementation with lutein (L) capsules on macular pigment optical density (MPOD) and visual acuity (VA) in patients with early age-related macular degeneration (AMD). A randomized, double-blind, placebo-controlled, two-center investigation of the effects of L supplementation in early AMD was conducted. The duration of the trial was 12 months. The centers were Manchester, United Kingdom and Maastricht, the Netherlands. L capsules (10 mg Ester) or a placebo (P) were taken daily. There were 72 patients (mean age 70.5 ± 8.7) assigned randomly to either L (n = 36) or P (n = 36) groups. MPOD using a flicker-based technique (MPS9000) and best corrected VA (LogMAR) were measured at the beginning and at 4-month intervals over the duration of the 12-month supplementation period. Blood serum samples were collected to monitor compliance. At the end of the trial, an overall increase in the mean MPOD level was found for the L group from 0.38 ± 0.19 to 0.53 ± 0.22 optical density (OD) units. According to a mixed design ANOVA, this was statistically significant (P < 0.001). No change in MPOD was found for the P group. There was no significant change in VA in the L group (n = 36). The P group (n = 36) showed a statistically significant deterioration from 0.05 ± 0.13 to 0.09 ± 0.13 (P < 0.05). When comparing the change in VA over the supplementation period, there was a significant difference between the two groups (P < 0.05). To avoid ceiling effects, 2 subgroups of patients with VA worse than 0.06 at baseline were reanalyzed. In the L subgroup (n = 19) a mean improvement in VA from 0.23 ± 0.12 at baseline to 0.16 ± 0.10 at visit 4 was observed (P < 0.05). In the P subgroup (n = 14), there was a small deterioration from 0.18 ± 0.13 to 0.19 ± 0.12 (P = 0.70). The improvement in VA in the L subgroup was compared to the deterioration in VA in the P group and this effect reached statistical significance (P < 0.05). L supplementation increases MPOD levels in early stage AMD patients. According to the VA measurements, the progress of the disease might be slowed in some patients with augmented levels of MP. (ClinicalTrials.gov number NCT01042860.).

A randomized placebo-controlled study on high-dose oral algal docosahexaenoic acid supplementation in children with cystic fibrosis

Low plasma concentrations of docosahexaenoic acid (DHA) are reported in unsupplemented cystic fibrosis (CF) patients. Forty-one CF patients aged from 6 to 12 years were randomized to receive high-dose DHA (100mg/kg/day in the first month and 1g per day thereafter through a 12-month supplementation) or placebo (germ oil). Primary outcome was percentage change in plasma AA:DHA ratio. Secondary outcomes were changes in the number of pulmonary exacerbations compared to previous year, lung function, BMI, skinfold thicknesses, and body composition assessed by DXA and in serum concentrations of C-reactive protein, cytokines and vitamin (α-tocopherol and retinol). Compared to the control group plasma AA:DHA ratio decreased in the intervention group after 6 months (median percentage changes: −73% in the intervention group vs. −10% in the control group, P=0.001). No differences were detected between groups for secondary outcomes. Despite a decrease of the AA/DHA ratio, DHA supplementation for one year did not induce any significant biochemical and clinical improvement in CF patients.

Supplementation with L-arginine favorably influences plasminogen activator inhibitor type 1 concentration in obese patients. A randomized, double blind trial.

Elevated plasminogen activator inhibitor type 1 (PAI 1) plays an important role in the pathogenesis of excess blood coagulability in obese patients. L-arginine supplementation has shown to be associated with enhanced cardiovascular and metabolic health. The aim of the study was to assess the effect of L-arginine supplementation on PAI 1 concentration and to evaluate the relation to changes in nitric oxide (NO) plasma level, insulin sensitivity (M value), and total antioxidant status (TAS) in obese patients. A randomized, double-blind, placebo-controlled study was conducted from March 2010 to June 2011. Eightyeight obese patients were randomly assigned to receive either 9 g of L-arginine or placebo daily for 6 months. At baseline and after 6 months, selected anthropometrical measurements and blood biochemical analyses were performed, and PAI 1, NO, TAS levels were assessed. Insulin sensitivity was evaluated using the hyperinsulinemic euglycemic clamp technique. We found that 6-month L-arginine supplementation resulted in significant decrease of PAI 1. Significant increase of NO, TAS, and insulin sensitivity level were noticed. In a group of patients treated with L-arginine, negative correlation between a change of insulin sensitivity value and a change of PAI 1 concentration was found. The present findings demonstrate favorable influence of L-arginine supplementation on PAI 1 concentration in obese patients. Beneficial influence is related to insulin sensitivity improvement. The potential therapeutic role of L-arginine administration in patients with obesity needs further investigation.

Insulin Resistance and Adiposity in Relation to Serum β-Carotene Levels

To determine the effects of placebo vs an encapsulated supplement of fruit and vegetable juice concentrate (FVJC) on serum β-carotene levels, insulin resistance, adiposity, and subclinical inflammation in boys. Thirty age-matched prepubertal boys (9 lean and 21 overweight (OW); age range, 6-10 years) were studied. All participants received nutrition counseling and were randomized to receive FVJC or placebo capsules for 6 months. Total cholesterol, triglycerides, lipid corrected β-carotene, serum retinol, glucose, insulin, retinol binding protein-4, leptin, adiponectin, leptin-to-adiponectin ratio, high-sensitivity C-reactive protein, and interleukin-6 were measured before and after the 6-month intervention. Homeostasis model assessment-insulin resistance (HOMA-IR), acute insulin response to intravenous glucose, along with abdominal fat mass (dual-energy x-ray absorptiometry) were also determined. Baseline β-carotene concentrations correlated inversely with HOMA-IR, leptin-to-adiponectin ratio, and abdominal fat mass (P ≤ .01). FVJC intake increased β-carotene concentrations (P ≤ .001) but did not influence retinol or retinol binding protein-4. Retinol insufficiency <1.047 μM was present in 18% of the entire cohort at baseline and in 37% at 6 months. HOMA-IR decreased after supplementation in the OW cohort, when adjusted for percent weight change (P = .014). The percent change in abdominal fat mass increased in the placebo group and decreased in the FVJC group (P = .029). A 6-month supplementation with FVJC in the presence of nutritional counseling was associated with an increase in serum β-carotene concentrations and a reduction in adiposity in conjunction with an improvement in insulin resistance in OW boys.

Effects of vitamin A, vitamin A plus zinc, and multiple micronutrients on anemia in preschool children in Chongqing, China.

This study is to clarify the impact of vitamin A or vitamin A combined with other micronutrients supplementation on anemia and growth in preschoolers. In the present study, a total of 290 preschoolers, aged 36-72 months old were randomly assigned to 3 treatment groups: vitamin A (A group), vitamin A plus zinc (AZ group), and vitamin A combined with additional multiple-micronutrient (AMM group). After 6-month supplementation, the height and height-for-age z-score gains of the AZ group were significantly higher than the other groups; the weight gain of the AMM group was greater than the other groups. Compared with baseline values, the concentrations of hemoglobin, and zinc at the end significantly increased in all 3 groups. The incremental concentrations of hemoglobin in the AMM group were significant higher than in the other two groups. Furthermore, the incremental concentrations of serum retinol in the AMM group, and the increase in serum zinc concentrations in the AZ group were significantly higher, respectively, than in the other groups. These 3 kinds of supplements in the present study are effective in enhancing height gains and are effective in reducing the prevalence of anemia. Supplementation of zinc plus vitamin A is a better way for improving children's height and height-for-age z-score. Vitamin A combined with multiple-micronutrient is more effective in improving the hemoglobin concentrations in preschool children.

Effect of diindolylmethane supplementation on low-grade cervical cytological abnormalities: double-blind, randomised, controlled trial

Background:Cervical screening identifies many women with low-grade abnormalities. In vitro and in vivo studies have shown that diindolylmethane (DIM) could potentially halt (cervical) carcinogenesis. We report on a randomised controlled trial of the effect of DIM in women with low-grade cervical cytological abnormalities.Methods:We conducted a pragmatic double-blind, randomised controlled trial of 150 mg DIM (from BioResponse DIM) or placebo daily for 6 months in women with newly diagnosed, low-grade cytological abnormalities. Randomisation was in the ratio 2 (DIM) to 1 (placebo). All women were invited for colposcopy at 6 months with biopsy of any abnormality.Results:Of the 551 randomised women available for analysis, 9% on DIM and 12% on placebo had cervical intraepithelial neoplasia-2 (CIN2) or worse after 6-month supplementation (risk ratio (RR) 0.7 (95% confidence interval (CI): 0.4–1.2)), whereas 4.6% and 5.1%, respectively, had CIN3 or worse (RR 0.9 (95% CI: 0.4–2.0)). A total of 27.3% of women on DIM and 34.3% on placebo had no sign of disease (negative cytology, colposcopy and human papilloma virus (HPV) tests) at 6 months (RR 0.8 (95% CI: 0.6–1.0)). Of those HPV-positive at baseline, 69% (114 out of 166) of the DIM group were positive at 6 months compared with 61% (43 out of 71) of the placebo group: RR 1.1 (95% CI: 0.9–1.4). Diindolylmethane supplementation was well tolerated.Conclusion:The results suggest that short-term DIM supplementation (150 mg day−1) is well tolerated, but is unlikely to have an effect on cytology or HPV infection. Uncertainty remains regarding its effect on CIN2+.

Testosterone Therapy in Women With Chronic Heart Failure: A Pilot Double-Blind, Randomized, Placebo-Controlled Study

The primary objective of this study was to assess the effect of a 6-month testosterone supplementation therapy on functional capacity and insulin resistance in female patients with chronic heart failure (CHF). Patients with CHF show decreased exercise capacity and insulin sensitivity. Testosterone supplementation improves these variables in men with CHF. No study has evaluated the effects of testosterone supplementation on female patients with CHF. Thirty-six elderly female patients with stable CHF, (ejection fraction 32.9 ± 6) were randomly assigned (2:1 ratio) to receive testosterone transdermal patch (T group, n = 24) or placebo (P group, n = 12), both on top of optimal medical therapy. At baseline and after 6 months, patients underwent 6-min walking test (6MWT), cardiopulmonary exercise test, echocardiogram, quadriceps maximal isometric voluntary contraction, dynamic quadriceps isokinetic strength (peak torque), and insulin resistance assessment by homeostasis model. Distance walked at 6MWT as well as peak oxygen consumption significantly improved in the T group, whereas they were unchanged in the P group (p < 0.05 for all comparisons). The homeostasis model was significantly reduced in the T group in comparison with the P group (-16.5% vs. +5%, respectively; p < 0.05). Maximal voluntary contraction and peak torque increased significantly in the T group but did not change in the P group. Increase in distance walked at 6MWT was related to the increase in free testosterone levels (r = 0.593, p = 0.01). No significant changes in echocardiographic parameters were observed in either group. No side effects requiring discontinuation of T were detected. Testosterone supplementation improves functional capacity, insulin resistance, and muscle strength in women with advanced CHF. Testosterone seems to be an effective and safe therapy for elderly women with CHF.

Reducing Wasting in Young Children With Preventive Supplementation: A Cohort Study in Niger

To compare the incidence of wasting, stunting, and mortality among children aged 6 to 36 months who are receiving preventive supplementation with either ready-to-use supplementary foods (RUSFs) or ready-to-use therapeutic foods (RUTFs). Children aged 6 to 36 months in 12 villages of Maradi, Niger, (n = 1645) received a monthly distribution of RUSFs (247 kcal [3 spoons] per day) for 6 months or RUTFs (500-kcal sachet per day) for 4 months. We compared the incidence of wasting, stunting, and mortality among children who received preventive supplementation with RUSFs versus RUTFs. The effectiveness of RUSF supplementation depended on receipt of a previous preventive intervention. In villages in which a preventive supplementation program was previously implemented, the RUSF strategy was associated with a 46% (95% confidence interval [CI]: 6%-69%) and 59% (95% CI: 17%-80%) reduction in wasting and severe wasting, respectively. In contrast, in villages in which the previous intervention was not implemented, we found no difference in the incidence of wasting or severe wasting according to type of supplementation. Compared with the RUTF strategy, the RUSF strategy was associated with a 19% (95% CI: 0%-34%) reduction in stunting overall. We found that the relative performance of a 6-month RUSF supplementation strategy versus a 4-month RUTF strategy varied with receipt of a previous nutritional intervention. Contextual factors will continue to be important in determining the dose and duration of supplementation that will be most effective, acceptable, and sustainable for a given setting.

Calcium and vitamin-D supplementation on bone structural properties in peripubertal female identical twins: a randomised controlled trial

A randomised controlled trial was used in assessing the impact of 6 months of daily calcium and vitamin-D supplementation on trabecular and cortical bone acquisition at distal tibial and radial sites using peripheral quantitative computed tomography (pQCT). Daily supplementation was associated with increased bone density and bone strength at the distal tibia and radius. pQCT has not been used to assess bone responses to calcium and vitamin-D supplementation on peripubertal children. This randomised controlled trial aimed to assess the impact of a 6-month daily calcium and vitamin-D supplementation on trabecular and cortical bone acquisition at distal tibial and radial sites using pQCT. Twenty pairs of peripubertal female identical twins, aged 9 to 13 years, were randomly assigned to receive either 800 mg of calcium and 400 IU of vitamin D3, or a matched placebo. Bone structural properties at the distal tibia and distal radius were acquired at baseline and 6 months. The calcium-supplemented group showed greater gains in trabecular density, trabecular area and strength strain index at the 4% of distal tibial and radial sites compared with the placebo group (p=0.001). Greater gains in cortical area at the 38% and 66% of tibial sites were also found in twins receiving the calcium supplement (p=0.001). Daily supplementation for a period of 6 months was associated with increased trabecular area, trabecular density and strength strain index at the ultra-distal tibia and radius and increased cortical area at tibial mid-shaft.

A mild favorable effect of soy protein with isoflavones on body composition—a 6-month double-blind randomized placebo-controlled trial among Chinese postmenopausal women

In vitro and animal studies suggested that soy protein and isoflavones promote weight and body fat loss. However, clinical trials in humans were few and the effects remained uncertain. To examine whether soy protein with isoflavones and isoflavone extracts exert beneficial effects on body composition among postmenopausal women. A double-blind randomized placebo-controlled trial was conducted among 180 postmenopausal Chinese women with mild hyperglycemia. After a 2-week adaptation, participants were randomly assigned to one of the three arms to receive 15 g soy protein and 100 mg isoflavones (Soy group), or 15 g milk protein and 100 mg isoflavones (Iso group), or 15 g milk protein (placebo group) on a daily basis for 6 months. We observed a mild but significant favorable effect of soy protein with isoflavones on the changes of body weight (BW), body mass index, and body fat percentage relative to isoflavone extracts and milk protein after 6-month supplementation. The mean differences of BW between the Soy and the Iso groups were -0.75 kg (95% CI: -1.363 to -0.136, P=0.017), and between the Soy and the placebo groups were -0.60 kg (95% CI: -1.209 to -0.019, P=0.047). The mean difference of change percentage in body fat percentage between the Soy and the Iso groups was -3.74% (95% CI: -6.88 to -0.60%, P=0.02), and between the Soy and the placebo groups was -2.54% (95% CI: -5.69 to 0.12%. P=0.08). Six-month supplementation of soy protein with isoflavones had a mild favorable effect on body composition in postmenopausal women.

Treatment of Vitamin D Deficiency Increases Lower Limb Muscle Strength in Institutionalized Older People Independently of Regular Physical Activity: A Randomized Double-Blind Controlled Trial

Aims: To investigate the effects of a 6-month supplementation with calcium and cholecalciferol on biochemical parameters and muscle strength of institutionalized elderly. Methods: This prospective, double-blind, placebo-controlled, randomized trial included Brazilian institutionalized people ≥60 years of age receiving a 6-month supplementation (December to May) of daily calcium plus monthly placebo (calcium/placebo group) or daily calcium plus oral cholecalciferol (150,000 IU once a month during the first 2 months, followed by 90,000 IU once a month for the last 4 months; calcium/vitamin D group). Fasting blood samples for 25(OH)D, PTH and calcium determination were collected (n = 56) and muscle tests were performed (n = 46) to measure the strength of hip flexors (SHF) and knee extensors (SKE) before (baseline) and after the 6-month intervention (6 months). Results: Due to seasonal variations, serum 25(OH)D significantly enhanced in both groups after treatment, but the calcium/vitamin D group had significantly higher 25 (OH)D levels than the calcium/placebo group (84 vs. 33%, respectively; p < 0.0001). No cases of hypercalcemia were observed. While the calcium/placebo group showed no improvement in SHF and SKE at 6 months (p = 0.93 and p = 0.61, respectively), SHF was increased in the calcium/vitamin D group by 16.4% (p = 0.0001) and SKE by 24.6% (p = 0.0007). Conclusions: The suggested cholecalciferol supplementation was safe and efficient in enhancing 25(OH)D levels and lower limb muscle strength in the elderly, in the absence of any regular physical exercise practice.

Effects of β-carotene supplementation on adipose tissue thermogenic capacity in ferrets ( Mustela putorius furo)

We previously described that the intake of pharmacological doses of beta-carotene (BC) resulted in higher body weight gain in the ferret (Mustela putorius furo), an animal model that resembles human subjects in terms of intestinal BC absorption and metabolism. These results were some way unexpected considering the condition of BC as a vitamin A precursor and the previous data in rodents showing these compounds as thermogenic activators. Here, we aimed to characterise in the ferret whether the mentioned changes in body weight could be explained by changes in adipose tissue thermogenic capacity. We studied the effects of 6-month supplementation with BC (0.8 and 3.2 mg/kg per d) on adipose tissue morphology and uncoupling protein-1 (UCP1) content. BC supplementation resulted in higher body weight (the high dose), induced depot- and dose-dependent hypertrophy of white adipocytes, decreased the amount of brown-like multilocular adipocytes in the retroperitoneal depot and decreased UCP1 content in different fat depots. To ascertain whether BC effects could be mediated by retinoic acid (RA), 1 week supplementation with RA (0.25 and 25 mg/kg per d) was also studied. RA treatment resulted in a slight decrease in adiposity, decreased cell lipid accumulation and increased UCP1 content, suggesting that the effects of BC on thermogenic capacity are not through RA. In conclusion, RA, but not BC, may have in the ferret comparable effects with those described in rodents, whereas differences concerning BC and RA treatments may be attributable to the different BC metabolism in the present animal model with a lower conversion of BC to RA compared with rodents.

Effects of Nutrient Fortified Complementary Food Supplements on Anemia of Infants and Young Children in Poor Rural of Gansu

To assess the effectiveness of complementary food supplements with protein and multi-micronutrients on hemoglobin and anemia in infants and young children. In 5 poor counties of Gansu, 984 children aged 6-12 months were enrolled and divided into two groups. In addition to the usual home-made complementary food, all the children were fed one sachet of either Formula I or Formula II supplements each day. Protein and micronutrients were provided in Formula I, while the same energy intake was secured in Formula II as in Formula I. A massive dose of vitamin A was supplemented to all the children every 6 months. Hemoglobin test was done at the same time. Prevalence of anemia was about 35% in both Formula I and Formula II group at baseline, and there were no differences in hemoglobin concentration between the two groups. During the 6-month and 12-month supplementation, hemoglobin of children in Formula I group was higher than that in Formula II group (P < 0.05), and hemoglobin increase in Formula I group was significantly higher than that in Formula II group (P < 0.001). After 6- and 12-month supplementation, the prevalence of anemia in Formula I group dropped to 19.1% and 8.2% respectively, and it was 28.0% and 12.4% in Formula 2 group. The prevalence of anemia in Formula I group was significantly lower than that in Formula II group (P < 0.05). After adjusting age and hemoglobin level at baseline, the hemoglobin increase at age of 24 months in formula 1 group was higher (10.7 g/L vs 7.9 g/L, P < 0.0001). Micronutrient fortified complementary food supplements, with large-dose vitamin A, is effective for children aged 6-12 months in terms of iron deficiency prevention.

A dietary combination of omega-3 and omega-6 polyunsaturated fatty acids is more efficient than single supplementations in the prevention of retinal damage induced by elevation of intraocular pressure in rats

To evaluate the effect of a dietary combination of omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) compared to single PUFA supplementations on the outcome of a substantial elevation of intraocular pressure (IOP) in rats. Sprague Dawley rats were fed for 6 months with either a control diet, a diet enriched with omega-3 PUFAs (eicosapentaenoic acid, EPA, and docosahexaenoic acid, DHA), a diet enriched with omega-6 PUFAs (gamma-linolenic acid, GLA) or a diet enriched with both omega-3 and omega-6 PUFAs (EPA + DHA and GLA). After 3 months of feeding, elevation of IOP was induced by photocoagulation of the episcleral veins, limbus and trabecular meshwork using a 532-nm laser. IOP and scotopic electroretinograms (ERGs) were monitored after the induction of IOP elevation until the end of the nutritional supplementation. Retinal morphometry and GFAP immunohistochemistry were performed 3 months after laser photocoagulation. Retinal ganglion cells (RGCs) were quantified using retrograde labelling. A significant rise in IOP was observed in the laser-treated eyes. PUFA supplementation did not influence the time course of IOP in the laser-treated eyes. Three months after laser photocoagulation, the activation of glial cells observed in the laser-treated eyes was significantly lower in animals fed with the EPA + DHA + GLA diet when compared to those fed the control diet, while single supplementations with either EPA + DHA or GLA were not effective. The same protective effect of the EPA + DHA + GLA combination was observed on retinal structures in the laser-treated eyes. However, PUFA supplementation did not influence either ERG b-wave amplitude or the RGC loss in the laser-treated eyes. This study demonstrates that a 6-month supplementation with a combination of omega-3 and omega-6 PUFAs is more effective than single supplementations, since the EPA + DHA + GLA dietary combination prevented retinal cell structure and decreased glial cell activation induced by the elevation of IOP in rats.