Double-blind Placebo-controlled Intervention Study Research Articles

Randomised double-blind placebo-controlled intervention study on the nutritional efficacy of a food for special medical purposes (FSMP) and a dietary supplement in reducing the symptoms of veisalgia

ObjectiveTo assess whether the symptoms of veisalgia can be reduced by intense water supply and the intake of antioxidative supplements and plant extracts.MethodsWe performed the world’s largest randomised double-blind placebo-controlled...

Effects of Whole Grain Wheat Bread on Visceral Fat Obesity in Japanese Subjects: A Randomized Double-Blind Study.

Metabolic syndrome is a risk factor for cardiovascular diseases and has become increasingly common in Japan. Epidemiological studies show inverse associations between intake of whole wheat grains and metabolic syndrome, but few dietary intervention trials have investigated the effect of whole wheat grain consumption. It was investigated whether a diet in which refined wheat bread (RW diet) was substituted by whole grain wheat bread (WW diet) would reduce visceral fat obesity in Japanese subjects. A randomized double-blind placebo-controlled intervention study was conducted in 50 Japanese subjects with body mass index (BMI) ≥ 23kg/m2. Subjects were randomly assigned WW (WW group) or RW diets (RW group) for 12weeks. Blood samples and computed tomography scans were obtained every 6th week. The WW group showed decrease (-4 cm2) in visceral fat area (VFA) (p< 0.05), whereas the RW group showed no significant changes. These time-dependent changes were significantly different between the groups. WW diet led to significant and safe reductions in VFA in subjects with BMI ≥ 23kg/m2. WW diet may contribute to preventing visceral fat obesity.

A canine-specific probiotic product in treating acute or intermittent diarrhea in dogs: A double-blind placebo-controlled efficacy study

A double-blind placebo-controlled intervention study on 60 dogs recruited from a pool of canine patients visiting a veterinary practice and diagnosed with acute diarrhea was conducted. The dogs received in randomized manner either a sour-milk product containing three canine-derived Lactobacillus sp. probiotics in combination of Lactobacillus fermentum VET 9A, L. rhamnosus VET 16A, and L. plantarum VET 14A (2×109cfu/ml), or placebo. Stool consistency, general well-being, and the numbers of specific pathogens in stool samples were analyzed.Our results demonstrated that the treatment with the study sour-milk product had a normalizing effect on canine stool consistency. The treatment also enhanced the well-being of the pet by maintaining appetite and may reduce vomiting. In addition, the concentrations of Clostridium perfringens and Enterococcus faecium, which typically increase during diarrhea episodes in dogs, were decreased in probiotic group feces when compared with the placebo group.Taken together, the sour-milk with the specific probiotic combination had a normalizing effect on acute diarrhea in dogs which was associated with decreased numbers of potential pathogens in the feces of probiotic-treated dogs.

P79 ‐ AsthmaVent – effect of mechanical ventilation on asthmacontrol in house dust mite allergic children with asthma

Background House dust mite allergy is a frequent cause of asthma in children. Children with house dust mite allergy and asthma are especially sensitive to physical and chemical agents in the indoor air and as children spend a lot of time indoors, it seems reasonable to believe that improving the indoor environment will lead to an improvement in asthma disease. At present, there is no clear consensus on the effect of ventilation on asthmatic children with house dust mite allergy. Earlier studies have been criticized for being small, poorly carried out and inconclusive. Thus there is a need for a powerful and methodologically rigorous study to provide significant evidence as a basis for the future treatment of children with house dust mite allergy and asthma. Objective This study started in the fall 2012 and aims at investigating whether mechanical ventilation is able to improve asthma symptoms during the winter season for children with house dust mite allergy and asthma. Materials and methods The study is a randomized double-blind placebocontrolled intervention study, with 9 months of intervention and follow-up. 80 children are included from 3 Danish hospitals and are randomized into two groups. The intervention is mechanical ventilation in the child’s bedroom. We monitor indoor air quality and health outcomes every three months. Primary outcomes are minimal effective dose of inhalation steroids and reduction in levels of particulate matter and house dust mite allergen. Perspectives Asthma patients and their families rely on good evidencebased advice on behavior and design of housing, so that the specific and non-specific factors in the indoor environment that trigger the disease are controlled as well as possible. The results of this project will be a significant contribution to the recommendations that can be given in relation to the effect of ventilation on indoor air quality in the asthma control of house dust mite allergic children.

Effects of Idebenone on Color Vision in Patients With Leber Hereditary Optic Neuropathy

Background:The authors investigated the correlation of protan and tritan color vision with disease characteristics in Leber hereditary optic neuropathy (LHON). The authors also characterized the therapeutic potential of idebenone in protecting patients from developing dyschromatopsia in LHON.Methods:Color contrast data of 39 LHON patients participating in a randomized, double-blind placebo-controlled intervention study were evaluated. Patients reported disease onset <5 years before enrolment and were genetically confirmed. Protan and tritan color contrast sensitivity was measured using a computer graphics method in patients receiving idebenone (Catena; 900 mg/d; N = 28) or placebo (N = 11) for 6 months.Results:Mean age of patients was 28.1 years, 87.2% were men, 76.9% carried the m11778G>A mutation, and mean duration since onset was 2 years. Assessing protan and tritan color vision at baseline revealed a high degree of color confusion even in young patients (<25 years) and with a short history of disease (<1 year). Treatment with idebenone improved tritan color vision compared with placebo (P = 0.008 at week 24); a similar trend was seen for protan. The effect of idebenone was most prominent in patients with discordant visual acuity (interocular difference of logMAR >0.2). In this subgroup, the treatment effect at week 24 was 20.4% (P = 0.005) in favor of idebenone for the tritan color domain and 13.5% (P = 0.067) for the protan domain.Conclusion:This study confirms that protan and tritan color confusion is an early symptom in LHON. Treatment with idebenone can protect from loss of color vision, particularly in patients who are at imminent risk of further vision loss.

Modification of Antioxidant Status by Ingesting Angelica keiskei (Ak) and/or Glycine max (Gm) in Subjects with Metabolic syndrome (MS)

MS is associated with elevated oxidative stress. We have reported that Ak, a vegetable rich in bioavailable phytochemicals, can increase antioxidant performance. To determine the effect of dietary modification on antioxidant status and DNA damage using Ak and/or Gm, a randomized double-blind placebo controlled intervention study was conducted. Thirty-two non-smoking men and post-menopausal women (>50 yr) with MS were randomly assigned to one of 4 groups, consuming two nutrition bars containing 1) placebo, 2) Ak (5 g), 3) Gm (5g), or 4) Ak (2.5 g) + Gm (2.5 g). Blood samples were collected on d1, 15, 29 and 43. Plasma carotenoids and tocopherol concentrations were analyzed by a HPLC system, total antioxidant performance (TAP) by fluorometry and lymphocyte DNA damage by single cell gel electrophoresis (comet). The combination of Ak + Gm showed significant increase in TAP on d29 as compared with the baseline (p=0.003). Ak+Gm and Ak also showed significant increase in plasma lutein concentration on d29 as well as d43 as compared to the baseline (p<0.05). Plasma β-carotene concentration was significantly higher in Ak group as compared to the placebo group on d29 (p=0.002). The data on DNA damage are being analyzed. The current study indicated that dietary modification using Ak and Gm increase plasma carotenoid concentrations and antioxidant performance. [Supported by USDA ARS #58-1950-7-07, USA and BioGreen 21 #20070301034009 RDA, Korea]

Biochemical hypogonadism in men with type 2 diabetes in primary care practice

Objective: This study explores the links between testosterone deficiency and Quality Outcomes Framework (QOF) parameters in three south Staffordshire practices prior to a major double-blind placebo-controlled intervention study. Research design and methods: Four hundred and eighty-eight consecutive type 2 diabetic patients, aged over 18, attending their general practitioner for routine diabetes visits were assessed for sex hormone binding globulin, total testosterone (TT), calculated free testosterone (FT) and bioavailable testosterone, glycated haemoglobin A1c (HbA1c), body mass index, waist circumference, blood pressure, lipid profile, Sexual Health Inventory for Men, and current and past prescriptions for erectile dysfunction (ED). Results: TT and FT were significantly inversely associated with raised body mass index, waist circumference and HbA1C. The prevalence of ED was 77%, which was associated with low levels of TT, FT and raised HbA1C. Only 10% were receiving treatment for ED. Conclusions: Patients with low testosterone were more likely to fall outside the QOF targets and new markers might be difficult to achieve unless low testosterone is addressed. There is a strong case for the inclusion of TT and FT estimation in routine diabetic care.

No effect of fish oil supplementation on serum inflammatory markers and their interrelationships: a randomized controlled trial in healthy, middle-aged individuals

A high intake of n-3 polyunsaturated fatty acids (PUFAs), mainly present in fish, may be associated with decreased inflammation. Previous intervention studies on fish PUFA and inflammatory markers in healthy individuals did not analyze a broad spectrum of inflammatory cytokines, chemokines and cell adhesion molecules, or their interrelationships. Therefore, we determined the effects of fish oil supplementation on 19 serum inflammatory markers and their interrelationships in healthy, middle-aged individuals. Individuals (n=77) aged 50-70 years completed a randomized, double-blind placebo-controlled intervention study. Participants received 3.5 g/day fish oil (1.5 g/day total n-3 PUFA) (n=39) or placebo (high oleic sunflower oil) (n=38) for 12 weeks. Serum concentrations of 19 inflammatory markers were determined using a multiplex immunoassay before and after intervention. Changes in concentrations were analyzed using analysis of covariance and differences in patterns in inflammatory markers between the fish oil and placebo group were analyzed by principal component analysis. Fish oil supplementation did not significantly affect serum concentrations of cytokines, chemokines or cell adhesion molecules as compared with placebo. However, there was a trend for all inflammatory markers to increase after fish oil supplementation. PCA did not result in markedly distinctive patterns of inflammatory markers for the fish oil and placebo group. In conclusion, this 12-week randomized, double-blind placebo-controlled intervention trial did not show that 1.5 g/day n-3 PUFA significantly affected the serum inflammatory response in healthy individuals, nor did patterns of inflammatory markers. Thus, a healthy middle-aged population may not benefit from fish oil as an anti-inflammatory agent.

O0058* EFFECT OF ZINC SUPPLEMENTATION IN 6???36 MONTH AGE CHILDREN WITH FAILURE TO THRIVE AT NORTHWEST OF TABRIZ DISTRICT OF IRAN

Introduction: Failure to thrive ( FTT ) is a common health problem in children. (1) Although the main causes of FTT are not yet fully understood, however the possible role of micronutrients particularly zinc deficiency in etiology of growth retardation has been the focus of much more attention in recent years. (2–4) The objective of present study was to determine the effect of zinc supplementation on the growth of children with FTT. Methods: A randomized double blind placebo-controlled intervention study was conducted in northwest of Tabriz. 68 FTT children of 6–36 month age matched for age and sex and randomized to receive daily 10mg of zinc ( as a zinc sulphate ) or a placebo for 6 months. Weight and height gain was measured at monthly interval throughout the study. The appetite status and susceptibility to the infectious diseases were, also, assessed. Results: The results showed that zinc supplementation in comparison with placebo led to a significant increment in height (4.7 cm vs 3.6 cm, P<0.01) but had no significant effect on weiht gain (1.4 Kg vs 1.1 Kg). On the basis of their mother reports, the rate of children suffering from infectious diseases and their appetite were remarkably approved in zinc supplemented group as comparing with placebo group. (77.1 and 74.4% vs 50 and 48.1% respectively). Conclusion: Based on the results of present study, Zinc deficiency could be one of the factors that affect the growth of 6–36 month age children.

Growth of colorectal polyps

One hundred and sixteen patients were included, during 18 months, in a double-blind placebo-controlled intervention study, with calcium, vitamins A, C, E and selenium (in a cocktail) or placebo against growth of colonic polyps. Patients were randomized within three arms, according to diameter of the largest polyp, < 5 mm, 5-9 mm or > 9 mm. Polyps > 9 mm were resected, the others were left to be measured annually before resection after 3 years. The protocol (performed in all of the patients) included registration of demographic data, family and personal history, measurement of polyps, collection of blood specimens, stools and biopsy samples. Registration of nutritional status, diet history and 5-day prospective food consumption, was performed in 108 patients. The patient compliance was registered every third month by the hospital pharmacist, with concomitant delivery of new boxes of capsules. Additionally, stool collections were performed from all of the patients for the measurement of faecal calcium, bile salts and fat. Inclusion rate of 37, 41 and 38 patients in each of the three 6-month periods was uniform. The group with the largest polyps measuring 5-9 mm comprised 44% of the material. The sex ratio corresponded to that in overall referrals for colonoscopy. The age relationship of size and multiplicity of polyps and the distribution of polyps in the large bowel corresponded to previous experience in polyp-bearing individuals of the same age.(ABSTRACT TRUNCATED AT 250 WORDS)