Therapeutic Lifestyle Changes Diet Research Articles

Pantethine, a derivative of vitamin B5 used as a nutritional supplement, favorably alters low-density lipoprotein cholesterol metabolism in low– to moderate–cardiovascular risk North American subjects: a triple-blinded placebo and diet-controlled investigation

Safety and efficacy of a biologically active derivative of vitamin B(5) (pantethine) on total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) metabolism was studied in North American subjects at conventional low to moderate cardiovascular disease (CVD) risk. A total of 120 subjects initiated a therapeutic lifestyle change (TLC) diet 4 weeks before randomization (baseline) and maintained the diet throughout a 16-week study period; at baseline, subjects were randomized in a triple-blinded manner to either pantethine (600 mg/d, baseline to week 8, and 900 mg/d, weeks 9-16) or identically labeled, nonbiologically active placebo (n = 60 per group). We hypothesized that pantethine would lower TC and low-density lipoprotein in low-CVD-risk North American subjects in a similar manner as reported in high-CVD-risk subjects studied mainly in Italy and Japan. While sustaining a TLC diet and in comparison with placebo, pantethine demonstrated significant (P < .005) and sustained reductions (from baseline to week 16) in TC (6 mg/dL, 0.16 mmol/L, 3%), LDL-C (4 mg/dL, 0.10 mmol/L, 4%), and apolipoprotein B (4 mg/dL, 0.04 g/L, 5%). Our data suggest that pantethine supplementation for 16 weeks (600 mg/d for weeks 1-8 then 900 mg/d for weeks 9-16) is safe and significantly lowers TC and LDL-C over and above the effect of TLC diet alone. Although the absolute magnitude of these effects was small in these low- to moderate-risk North Americans (4-6 mg/dL), the results are noteworthy as prior studies have shown that, for each 1 mg/dL (0.026 mmol/L) reduction in LDL-C, there is a concomitant 1% reduction in overall future CVD risk.

Effect of nutritional intervention on the prevalence of metabolic syndrome and heart disease risk factors in urban Tehran [Tehran Lipid and Glucose Study

In a case-control study a nutritional intervention consisting of an educational program based on the Therapeutic Lifestyle Change diet (TLC) guidelines was implemented in one area of Tehran. Data were collected from subjects in the intervention area (n =133) and controls from another area (n = 183), before and 3.8 years after the intervention. Mean energy and macronutrient intakes and prevalence of risk factors including metabolic syndrome were compared between and within cases and controls. Baseline and follow-up evaluations showed improvement in hypercholesterolemia and high LDL cholesterol levels in cases versus controls. Central obesity and low HDL cholesterol levels increased significantly in controls but not in cases. As there were no significant differences between the 2 groups in energy and macronutrient intakes, it is difficult to claim that nutritional interventions played an important role.

Controlling diet in a clinical trial of the effects of barley beta glucan on glucose metabolism and insulin sensitivity in subjects at high risk for type 2 diabetes

We used the Therapeutic Lifestyle Changes (TLC) diet to counsel subjects in a clinical trial designed to assess the impact of a flavored, water beverage containing barley β‐glucan (barley betafiber; BarlivTM) on glucose levels and insulin sensitivity. The beverage was consumed three times a day for 12 weeks, providing 0 grams, 3 grams or 6 grams of β‐glucan per day. Adherence to the TLC diet was assessed using 3‐day food records at baseline, 3, 6, 9 and 12 weeks of the trial. Dietary intake data was analyzed using the Nutrient Data System for Research software. Subjects had improvements in glucose levels and insulin sensitivity during this trial while they maintained their weight (as required) during the trial by following the TLC diet. P‐values for comparisons of macronutrient intake among and between randomization groups and within randomization groups from baseline to 12 weeks were not significant (&gt; 0.05). Parameter [mean(SD)] 0 g/d BBG (n=13) 3 g/d BBG (n=11) 6 g/day BBG (n=14) Body Weight (kg) 92.3 (12.2) 90.9 (14.4) 90.7 (12.9) BMI (kg/m2) 32.1 (3.7) 32.2 (4.5) 32.2 (4.9) Energy (kcal) 1687 (383) 1720 (322) 1513 (319) Fat (g) 61 (18) 68 (22) 58 (20) Fat (% energy) 31 (7) 34 (7) 33 (8) Carbohydrate (g) 199 (63) 195 (26) 175 (67) Carbohydrate (% energy) 46 (7) 45 (9) 44 (10) Protein (g) 83 (23) 75 (26) 75 (16) Protein (% energy) 21 (7) 18 (4) 21 (4) Fiber (g) 19 (7) 18 (7) 20 (12) This trial demonstrates the application of the TLC diet and analysis of dietary intake data to a clinical trial setting in which weight maintenance and stability of the diet is preferred in order to isolate the effects of a nutritive test article.

Does Stage of Change Modify the Effectiveness of an Educational Intervention to Improve Diet among Family Members of Hospitalized Cardiovascular Disease Patients?

Objective The purpose of this study was to evaluate whether effectiveness of a special intervention to improve diet vs a control intervention differs by readiness to reduce dietary saturated fat based on the Transtheoretical Model Stages of Change among family members of hospitalized cardiovascular disease patients. Design Stages of change (ie, precontemplation, contemplation, preparation, action, maintenance) were assessed by standardized questionnaire. Diet was measured by Block 98 Food Frequency Questionnaire at baseline and 1 year in participants in the Family Intervention Trial for Heart Health (n=501; 36% racial/ethnic minorities; 66% female). Therapeutic Lifestyle Change diet education was provided to each special intervention subject tailored to baseline stage of change. Statistical analyses Multivariable linear regression was used to examine whether the effect of the intervention was modified by stage of change. Results Baseline saturated fat and cholesterol intakes were lower among those in maintenance stage vs others (9.9% vs 11.2% kcal; P<0.0001 and 112.2 vs 129.7 mg/1,000 kcal; P=0.0003, respectively). Overall, change in the percentage of calories from saturated fat from baseline to 1 year was −0.7 in the special intervention vs −0.4 in the control intervention ( P=0.18). Among participants in contemplation, greater reductions in saturated fat (−2.1% vs + 0.3% kcal; P=0.04) and cholesterol (−34.0 vs + 32.6 mg/1,000 kcal; P=0.01) were seen in the special intervention vs control intervention. The special intervention was more likely than control intervention to achieve new adherence to a diet of <10% saturated fat/<300 mg cholesterol at 1 year among those not in maintenance stage (30% vs 15%; P=0.03). Control intervention participants were more likely than special intervention to revert to lower levels on the stage of change continuum from baseline to 1 year (17% vs 7%; P=0.002). Conclusion Effectiveness of an intervention to lower saturated fat varies by baseline stage of change among family members of hospitalized cardiovascular patients. This can be important to consider when designing research or clinical diet interventions.

Effects of consuming a yogurt containing plant sterols, as part of a Therapeutic Lifestyle Changes (TLC) Diet, on blood lipids in men and women with primary hypercholesterolemia

Objective was to assess the effects of an intervention involving TLC diet, including consumption of a plant sterol containing yogurt, on the fasting lipoprotein lipid profile and blood pressure in men and women with primary hypercholesterolemia. Study included men and women (n = 34), 40–69 yrs, with fasting LDL‐C of 130–210 mg/dL. At week 0, participants were instructed on the TLC diet and provided with yogurt to be consumed twice daily (0.6 g plant sterol/serving) for six weeks. Fasting lipids were measured at baseline (weeks ‐1 and 0) and weeks 2, 4, and 6. Participants were mostly female (73.5%) and of non‐Hispanic white ethnicity (91.2%) with a mean age of 52.7 yrs and BMI of 26.8. Significant reductions from baseline were observed for LDL‐C (−8.2 %; p &lt; 0.001), TC (−6.9 %; p &lt; 0.001), non‐ HDL‐C (−7.3 %; p &lt; 0.001) and HDL‐C (−4.5 %; p = 0.023). Blood pressure decreased from 121.5/76.9 mm Hg at baseline to 116.1/74.6 mm Hg at the end of treatment (p &lt; 0.03 for systolic and diastolic). The mean MEDFICTS score decreased from week 0 (53.7) to week 6 (32.4; p &lt; 0.001), indicating compliance with the TLC diet. These results show that the TLC diet including consumption of yogurt containing plant sterols (1.2 g/day) was associated with improvements in total, LDL, and non‐HDL‐C and blood pressure in men and women with primary hypercholesterolemia.Funding: General Mills Bell Institute of Health and Nutrition, Minneapolis, MN.

Validation of the MEDFICTS Dietary Assessment Questionnaire in a Diverse Population

The National Cholesterol Education Program (NCEP) recommends MEDFICTS, a rapid screening instrument for dietary fat, to assess adherence to the Adult Treatment Panel (ATP) III Therapeutic Lifestyle Changes (TLC) diet (score <40 points indicates intake of <7% of energy from saturated fat, <30% of energy from total fat, and <200 mg dietary cholesterol/day). MEDFICTS has only been validated in small, select populations and its utility in diverse clinical settings is unknown. To evaluate the ability of MEDFICTS to identify individuals who are nonadherent to a TLC diet in an ethnically diverse population that includes both English- and Spanish-speakers. MEDFICTS was administered concurrently with the Gladys Block Food Frequency Questionnaire to participants (n=501; mean age 48+/-13.5 years; 36% nonwhite; 66% female) in the National Heart, Lung, and Blood Institute Family Intervention Trial for Heart Health (FIT Heart) at the baseline screening visit. Reliability and validity analyses were conducted overall and by sex, age, and race/ethnicity. MEDFICTS score correlated significantly with percentage of energy from saturated fat (r=0.52, P<0.0001), percentage of energy from total fat (r=0.31, P<0.0001), and milligrams per day of dietary cholesterol (r=0.54, P<0.0001). Sensitivity of MEDFICTS to correctly identify TLC diet adherence was 85.7% and did not differ significantly by sex, age, or race/ethnicity. Specificity of MEDFICTS to correctly identify nonadherence to the TLC diet was low (56.9%) and significantly worse for women than men (48.4% vs 72.9%; P<0.0001), but did not differ significantly in older vs younger participants or among white, black, or Hispanic participants. Our data suggest that sex-specific recalibration of MEDFICTS may improve specificity and clinical utility.

Effect of Soy Nuts on Adhesion Molecules and Markers of Inflammation in Hypertensive and Normotensive Postmenopausal Women

Recently, it was shown that substituting soy nuts for nonsoy protein in a therapeutic lifestyle change (TLC) diet lowered systolic and diastolic blood pressure by 9.9% and 6.8%, respectively, in postmenopausal women with hypertension and by 5.2% and 2.9%, respectively, in normotensive postmenopausal women. In this study, to examine mechanisms for these reductions, markers of inflammation were measured, including soluble vascular cell adhesion molecule-1, soluble intercellular adhesion molecule-1, C-reactive protein, interleukin-6, and matrix metalloproteinase-9. Sixty healthy postmenopausal women (48 normotensive and 12 with hypertension) were randomized in a crossover design to a TLC diet alone or a TLC diet in which 0.5 cups of soy nuts (25 g soy protein and 101 mg aglycone isoflavones) replaced 25 g of nonsoy protein daily. Each diet was followed for 8 weeks. Compared with the TLC diet alone, levels of soluble vascular cell adhesion molecule-1 were significantly lower on the soy diet in women with hypertension (623.6 +/- 153.8 vs 553.8 +/- 114.4 ng/ml, respectively, p = 0.003), whereas no significant differences were observed in normotensive women. Soy nuts were associated with a trend toward reduction in C-reactive protein in normotensive women. No effect on levels of soluble intercellular adhesion molecule-1, interleukin-6, or matrix metalloproteinase-9 was observed. In conclusion, the reduction in soluble vascular cell adhesion molecule-1 with soy nuts in women with hypertension suggests an improvement in endothelial function that may reflect an overall improvement in the underlying inflammatory process underlying atherosclerosis.

Abstract 2372: Validity of the MEDFICTS Dietary Assessment Questionnaire in a Diverse Population

Background: The National Cholesterol Education Program (NCEP) recommends MEDFICTS, a rapid dietary fat screening instrument, for assessment of adherence to the Adult Treatment Panel (ATP) III Therapeutic Lifestyle Change (TLC) diet (Score &lt; 40 points = &lt; 7% of calories from saturated fat, &lt;30% of calories from total fat, and &lt;200mg dietary cholesterol/day). MEDFICTS has only been validated in small, select populations and its utility in diverse clinical settings is unknown. The purpose of this study was to evaluate the ability of MEDFICTS to identify individuals non-adherent to a TLC diet against a gold standard in an ethnically diverse population. Methods: MEDFICTS was administered concurrently with the Gladys Block Food Frequency Questionnaire to participants (n=470; 35% non-white; 66% female; mean age 48.1 ± 13.6y) in the NHLBI F amily I ntervention T rial for Heart Health ( F.I.T. Heart ) at the baseline screening visit. Correlation, agreement, sensitivity and specificity analyses were conducted overall and by sex, age, and race/ethnicity. Results: MEDFICTS score correlated significantly with % calories from saturated fat (r=.51, p&lt;.0001), % calories from total fat (r=.30, p&lt;.0001), and mg/day dietary cholesterol (r=.53, p=&lt;.0001). Categorical agreement between MEDFICTS score &lt;40 and Gladys Block on TLC diet adherence was poor overall (κ = 0.07) and for individual TLC components: &lt;7% calories from saturated fat (κ=.12), &lt;30% calories from total fat (κ=.16), &lt;200mg dietary cholesterol per day (κ=.34). Sensitivity of MEDFICTS to correctly identify TLC diet adherence was 84% and did not differ significantly by sex, age, or race/ethnicity. Specificity of MEDFICTS to correctly identify non-adherence to TLC diet was low (57%) and was significantly worse for females than males (48% vs. 74%; p&lt;.0001), but did not differ significantly in older vs. younger participants or among whites and non-whites. Conclusion: The NCEP ATP III MEDFICTS dietary assessment questionnaire performed poorly as a screening tool to correctly identify patients non-adherent to a TLC diet. Our data suggest a re-calibration of the instrument to improve specificity may increase its clinical utility.

Effect of Soy Nuts on Blood Pressure and Lipid Levels in Hypertensive, Prehypertensive, and Normotensive Postmenopausal Women

Epidemiologic studies suggest a low incidence of cardiovascular disease in populations that consume dietary soy. For people aged 40 to 70 years, each increment of 20 mm Hg in systolic blood pressure (BP) or 10 mm Hg in diastolic BP doubles the risk of cardiovascular disease for BPs of 115/75 to 185/115 mm Hg. To determine the effect of soy nuts on systolic and diastolic BP and lipid levels, 60 healthy postmenopausal women were randomized in a crossover design to a Therapeutic Lifestyle Changes (TLC) diet alone and a TLC diet of similar energy, fat, and protein content in which soy nuts (containing 25 g of soy protein and 101 mg of aglycone isoflavones) replaced 25 g of non-soy protein. Each diet was followed for 8 weeks. Compared with the TLC diet alone, the TLC diet plus soy nuts lowered systolic and diastolic BP 9.9% and 6.8%, respectively, in hypertensive women (systolic BP> or =140 mm Hg) and 5.2% and 2.9%, respectively, in normotensive women (systolic BP<120 mm Hg). Further subdivision of normotensive women revealed that systolic and diastolic BPs were lowered 5.5% and 2.7%, respectively, in prehypertensive women (systolic BP of 120-139 mm Hg) and 4.5% and 3.0%, respectively, in normotensive women. Soy nut supplementation lowered low-density lipoprotein cholesterol and apolipoprotein B levels 11% and 8% (P = .04 for both), respectively, in hypertensive women but had no effect in normotensive women. Substituting soy nuts for nonsoy protein in a TLC diet improves BP and low-density lipoprotein cholesterol levels in hypertensive women and BP in normotensive postmenopausal women. These findings may explain a cardioprotective effect of soy.

The Association between Soy Nut Consumption and Decreased Menopausal Symptoms

Epidemiological studies suggest a low incidence of hot flashes in populations that consume dietary soy. The present study examined the effect of soy nuts on hot flashes and menopausal symptoms. Sixty healthy postmenopausal women were randomized in a crossover design to a therapeutic lifestyle changes (TLC) diet alone and a TLC diet of similar energy, fat, and protein content in which one-half cup soy nuts divided into three or four portions spaced throughout the day (containing 25 g soy protein and 101 mg aglycone isoflavones) replaced 25 g of nonsoy protein. During each 8-week diet period, subjects recorded the number of hot flashes and amount of exercise daily. At the end of each 8-week diet period, subjects filled out the menopausal symptom quality of life questionnaire. Compared to the TLC diet alone, the TLC diet plus soy nuts was associated with a 45% decrease in hot flashes (7.5 +/- 3.6 vs. 4.1 +/- 2.6 hot flashes day, respectively, p < 0.001) in women with >4.5 hot flashes/day at baseline and 41% in those with <or=4.5 hot flashes/day (2.2 +/- 1.2 vs. 1.3 +/- 1.1, respectively, p < 0.001). Soy nut intake was also associated with significant improvement in scores on the menopausal symptom quality of life questionnaire: 19% decrease in vasomotor score (p = 0.004), 12.9% reduction in psychosocial score (p = 0.01), 9.7% decrease in physical score (p = 0.045), and a trend toward improvement in the sexual score, with a 17.7% reduction in symptoms (p = 0.129). The amount of exercise had no effect on hot flash reduction. Substituting soy nuts for nonsoy protein in a TLC diet and consumed three or four times throughout the day is associated with a decrease in hot flashes and improvement in menopausal symptoms.

Medical Director Responsibilities for Outpatient Cardiac Rehabilitation/Secondary Prevention Programs

Medical Director Responsibilities for Outpatient Cardiac Rehabilitation/Secondary Prevention Programs

Effect of a therapeutic lifestyle change diet on immune functions of moderately hypercholesterolemic humans

Hypercholesterolemia is a risk factor for coronary heart disease (CHD) and also could contribute to impaired immune response. The National Cholesterol Education Program Expert Panel recommends a therapeutic lifestyle change (TLC) diet to reduce the risk for CHD. We investigated the effects of changing from a high-fat Western diet to a low-fat diet in accordance with a TLC diet on immune functions of older adults with hypercholesterolemia to determine whether improving the lipid profile via dietary intervention would have beneficial effects on immune functions. In a double-blind study, 18 subjects consumed both a Western diet (38% fat) and a TLC diet (28% fat) for 32 days in a randomized order. Measures of cellular immune responses, including delayed-type hypersensitivity (DTH) response, in vitro lymphocyte proliferation, and interleukin (IL)-2 production, and production of proinflammatory mediators, including tumor necrosis factor-alpha, IL-6, IL-1beta, and prostaglandin E2, were determined. DTH response and lymphocyte proliferative response increased significantly (29% and 27%, respectively) after consumption of a TLC diet. Our results indicate that consumption of a TLC diet enhances T cell-mediated immune functions in older adults with elevated cholesterol level. This might be a clinically important benefit, considering the decline of T cell-mediated immune functions with aging and evidence of impaired immune function associated with hypercholesterolemia.

IV. General Approach to Treatment—Goals and Thresholds

The basic principle that guides cholesterol-lowering intervention is that the intensity of treatment is directly related to the degree of risk for CHD events. Both short-term (10-year) risk and long-term risk must be considered for treatment decisions. Persons with existing CHD (or a CHD risk equivalent) are at the highest risk; for this reason, they have the lowest goal level for LDL cholesterol and receive the most intensive treatment. For persons without CHD, classification and treatment goals are based on the category of risk, of which there are two—multiple (2+) risk factors other than LDL, and 0-1 risk factor. Persons with 2+ risk factors have an LDL goal that is not quite as low as that for persons with CHD (or CHD risk equivalents). ATP III differs from ATP II in that it distinguishes three subcategories of risk among persons with multiple (2+) risk factors: 10-year risk for hard CHD >20 percent, 10-20 percent, and <10 percent. Among the group with multiple risk factors, those at highest risk receive the most intensive LDL-lowering therapy, and those with the lowest risk receive the least intensive therapy. For persons with 0-1 risk factor, LDL goal levels are not as low as for persons with multiple risk factors, and intensive LDL-lowering therapy is not required unless LDL cholesterol levels are very high. ATP III recommends that LDL cholesterol be the primary target of therapy. The LDL cholesterol goals for each risk category are shown in Table IV.1-1. View this table: Table IV.1-1. LDL Cholesterol Goals for Three Risk Levels Persons with CHD or CHD risk equivalent have an LDL cholesterol goal of 20 percent per 10 years) who has an LDL cholesterol goal …

Statins and the soul of medicine

Statins and the soul of medicine

Effect of addition of exercise to therapeutic lifestyle changes diet in enabling women and men with coronary heart disease to reach Adult Treatment Panel III low-density lipoprotein cholesterol goal without lowering high-density lipoprotein cholesterol

To reduce the risk for coronary heart disease, the Adult Treatment Panel III of the National Cholesterol Education Program has recommended a multifaceted lifestyle approach.1 The Therapeutic Lifestyle Changes (TLC) Diet has replaced the former Step 1 and Step 2 diets and consists of <7% saturated fat and <200 mg cholesterol for all subjects. The Adult Treatment Panel III guidelines recommend that if low-density lipoprotein (LDL) cholesterol is 100 to 129 mg/dl in subjects with coronary heart disease, drug treatment is optional, or if patients are already on drugs, no change in dose is necessary.1 To determine the additive effect of exercise to a TLC diet, we conducted a structured exercise and stress reduction program in subjects with coronary heart disease who were already following a TLC diet. Our hypotheses were: (1) that exercise and weight loss would result in significant reductions in LDL cholesterol and thus obviate the need to add or increase lipid-lowering medications; (2) that exercise and weight loss would result in reductions in triglyceride levels and thus prevent lowering of high-density lipoprotein (HDL) cholesterol in response to the TLC diet in women and men; and (3) that stress reduction and weight loss would have a beneficial effect on blood pressure.