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Dietary Approaches to Stop Hypertension: Rationale, Design, and Methods

Epidemiologic studies across societies have shown consistent differences in blood pressure that appear to be related to diet. Vegetarian diets are consistently associated with reduced blood pressure in observational and interventional studies, but clinical trials of individual nutrient supplements have had an inconsistent pattern of results. Dietary Approaches to Stop Hypertension (DASH) was a multicenter, randomized feeding study, designed to compare the impact on blood pressure of 3 dietary patterns. DASH was designed as a test of eating patterns rather than of individual nutrients in an effort to identify practical, palatable dietary approaches that might have a meaningful impact on reducing morbidity and mortality related to blood pressure in the general population. The objectives of this article are to present the scientific rationale for this trial, review the methods used, and discuss important design considerations and implications.

The DASH Diet, Sodium Intake and Blood Pressure Trial (DASH-Sodium): Rationale and Design

The DASH Diet, Sodium Intake and Blood Pressure Trial (DASH-Sodium) is a multicenter, randomized trial comparing the effects of 3 levels of sodium intake and 2 dietary patterns on blood pressure among adults with higher than optimal blood pressure or with stage 1 hypertension (120-159/80-95 mm Hg). The 2 dietary patterns are a control diet typical of what many Americans eat, and the DASH diet, which, by comparison, emphasizes fruits, vegetables, and low-fat dairy foods, includes whole grains, poultry, fish, and nuts, and is reduced in fats, red meat, sweets, and sugar-containing beverages. The 3 sodium levels are defined as higher (typical of current US consumption), intermediate (reflecting the upper limit of current US recommendations), and lower (reflecting potentially optimal levels). Participants are randomly assigned to 1 of the 2 dietary patterns using a parallel group design and are fed each of the 3 sodium levels using a randomized crossover design. The study provides participants with all of their food during a 2-week run-in feeding period and three 30-day intervention feeding periods. Participants attend the clinic for 1 meal per day, 5 days per week, and take home food for other meals. Weight is monitored and individual energy intake adjusted to maintain baseline weight. The primary outcome is systolic blood pressure measured at the end of each intervention feeding period. Systolic blood pressure is compared across the 3 sodium levels within each diet and across the 2 diets within each sodium level. If effects previously observed in clinical trials are additive, sodium reduction and the DASH diet together may lower blood pressure to an extent not as yet demonstrated for nonpharmacologic treatment. The DASH-Sodium results will have important implications for the prevention and treatment of high blood pressure.

Effect of a controlled high-fat versus low-fat diet on insulin sensitivity and leptin levels in African-American and Caucasian women

African-American women have been shown to be more insulin-resistant than age- and weight-matched Caucasian women, but the reasons for this difference are unclear. The purpose of the present study was to determine whether experimental manipulation of dietary fat intake has differential effects by race on insulin sensitivity (S(I)) in 20 African-American and 11 Caucasian women. Additionally, leptin levels before and after 3 weeks of an isocaloric high-fat ([HF] 50% fat, 35% carbohydrate, and 15% protein) or low-fat ([LF] 20% fat, 55% carbohydrate, and 15% protein) diet were compared. African-American and Caucasian women did not differ significantly in the body mass index (BMI) or percentage body fat at baseline. S(I) (adjusted for BMI) decreased on the HF diet and increased on the LF diet in both races combined relative to the baseline control (control, 2.42 +/- 0.22; HF, 2.29 +/- 0.22; LF, 2.75 +/- 0.21 x 10(-4) min(-1)/microU x mL; main effect of diet, P = .04). There was a 6% decrease in S(I) on the HF diet compared with the control in women of both races, while the LF diet increased S(I) by 6% in African-American and 20% in Caucasian women. Leptin levels increased by 14% on the HF versus control diet in African-Americans (35.2 +/- 3.0 v 30.8 +/- 3.0 ng/mL, P < .01), but did not change with diet in Caucasian women. Glucose and insulin administration had no effect on leptin levels. We conclude that a HF diet consumed over several weeks reduces S(I) in healthy women of both races; however, the magnitude of increase in S(I) on a LF diet is greater in Caucasian women. The HF diet significantly increased leptin levels in African-American women, although there were no other influences of diet, insulin, or race on serum leptin.

Normolipidemic Subjects With Low HDL Cholesterol Levels Have Altered HDL Subpopulations

Epidemiological studies have established that plasma concentration of HDL is inversely correlated with the risk of coronary heart disease, even in the absence of increased LDL cholesterol levels. We postulate that specific HDL subpopulations may be responsible for antiatherogenic properties of HDL. HDL subpopulations were quantitated by two-dimensional gel electrophoresis in 79 normolipidemic healthy male subjects. To eliminate the influence of diet, volunteers consumed an average American diet for 6 weeks. After the diet period, subjects were stratified according to their HDL cholesterol (HDL-C) levels to low HDL-C < 0.91 mmol/L (< 35 mg/dL), medium > 0.91 < 1.30 mmol/L (> 35 < 50 mg/dL), and high > or = 1.30 mmol/L (> or = 50 mg/dL) groups. Plasma triglycerides and insulin levels were in the normal range, but subjects with low HDL-C levels had higher concentrations of plasma triglycerides and insulin than subjects with medium or high HDL-C concentrations. The absolute concentration (mg/dL) of apoA-I in the largest alpha-migrating HDL subpopulation (alpha 1) was (P < .01) lower in the low HDL-C subjects compared with the medium and high HDL-C groups. The relative concentration (percent distribution) of apoA-I was decreased (P < .01) in alpha 1 and increased (P < .01) in alpha 3 subpopulations. A positive correlation between HDL-C and alpha 1 (P < .001) and a negative correlation between HDL-C and alpha 3 were observed. The inverse correlation of apoA-I distribution (relative concentration) between alpha 1 and alpha 3 suggests an interconversion of alpha 1 and alpha 3 subpopulations, possibly by cholesteryl ester transfer protein. Pre-beta subpopulations showed an inverse trend with HDL-C, while the pre-alpha subpopulation behaved similarly to the alpha-migrating subpopulation. Colocalization of apoA-I and apoA-II particles in the different HDL subpopulations demonstrated that alpha 1, pre-beta 1, and pre-beta 2 subpopulations are apoA-I-only particles rather than apoA-I:A-II particles.

Dietary Adherence in the Dietary Approaches to Stop Hypertension Trial

Participants in controlled feeding studies must consume all study foods and abstain from all other foods. In outpatient studies in which adherence may be compromised by free-living conditions, promoting, documenting, and monitoring dietary adherence are necessary. In the Dietary Approaches to Stop Hypertension (DASH) trial, a thorough participant screening process, an orientation session, and a run-in feeding period before randomization aided in the selection of participants who would most likely adhere to the demands of the study protocol. Throughout the feeding period, various educational and motivational techniques were used to encourage DASH participants to adhere to the dietary protocol. Both objective and subjective methods documented excellent participant adherence. Daily monitoring of individual adherence was based on meal attendance, body weight measurements, and daily diaries. Urinary sodium, potassium, phosphorus, and urea nitrogen values and an anonymous poststudy survey were used to evaluate adherence at the end of the study. Most DASH participants adhered to the feeding regimen by consuming only study foods and no other foods. When adherence lapsed, participants generally cited the lack of menu variety as a reason. Successful participant adherence to the constraints of an outpatient controlled feeding study is possible with carefully selected participants and a variety of adherence-promoting strategies incorporated into the study protocol.

Diet design for a multicenter controlled feeding trial : The DELTA Program

OBJECTIVE To describe the process and results of diet standardization, diet validation, and monitoring of diet composition, which were key components of protocol 1 of Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA-1), the initial protocol in a program of multicenter human feeding studies designed to evaluate the effects of amount and type of fat on lipoproteins and hemostasis parameters in various demographic groups. DESIGN DELTA-1 was based on a randomized, blinded, crossover experimental design. Three diets were fed for 8 weeks to 103 healthy men and women aged 22 to 67 years at 4 field centers. Diet A, an average American diet, was designed to provide 37% of energy from fat, 16% of energy from saturated fatty acids (SFAs); diet B (step 1 diet) was designed to provide 30% of energy from fat, 9% of energy from SFA; and diet C (low SFA diet) was designed to provide 26% of energy from fat, 5% of energy from SFA. Key features of diet standardization included central procurement of fat-containing foods, inclusion of standard ingredients, precision weighing of foods--especially sources of fat and cholesterol--and use of standardized written procedures. SETTING For menu validation, a set of 12 menus for each diet was prepared in duplicate and chemically assayed. For monitoring of diet composition during the study, an 8-day diet cycle (6 weekday and 2 weekend menus) was sampled by every field center twice during each of 3 feeding periods. STATISTICAL ANALYSES Means (+/- standard error) were calculated and compared with target nutrient specifications. RESULTS DELTA-1 was able to provide a standardized diet that met nutrient specifications across 4 field centers over 24 weeks of participant feeding spanning a total of 8 months. APPLICATIONS Prestudy chemical validation of menus and continuous sampling and assay of diets throughout the study are essential to standardize experimental diets and to ensure that nutrient target goals are met and maintained throughout a controlled multicenter feeding study.

Validation of diet composition for the Dietary Approaches to Stop Hypertension trial

The Dietary Approaches to Stop Hypertension trial involved 4 clinical sites at which 459 participants (in 5 cohorts) were fed 3 dietary patterns over 11 weeks per cohort. The 3 patterns were a control diet, a fruits and vegetables diet, and a combination diet. Before the intervention, key nutrient levels in each diet were validated at 2 energy levels (2,100 and 3,100 kcal) by chemical analysis of the prepared menus. During intervention, diets were sampled across all cohorts, sites, and energy levels, and 7-day menu cycle composites were assayed. In general, sodium, potassium, calcium, and magnesium in the validated menus for each diet/energy level met the nutrient targets, though moderate variability was evident among individual menus, particularly for potassium, calcium, and magnesium. However, as intended, there was clear separation and no overlap in mineral levels in individual menus of diets that were designed to differ. During intervention, macronutrient contents met nutrient goals. Sodium, potassium, calcium, and magnesium in the diets generally met target levels, though potassium in the fruits and vegetables diet was 11% to 23% below target. There were no consistent differences in nutrient levels between sites. The mean nutrient levels in the validated menus and diets sampled during intervention were in excellent agreement with each other, though sodium was somewhat higher (approximately 6%) in the diets from intervention vs validation. These results indicate the success of the quality control measures implemented and suggested consistent overall diet composition throughout the 28 months during which the study was conducted.

Pre-enrollment Diets of Dietary Approaches to Stop Hypertension Trial Participants

A large body of evidence suggests that several nutrients are related to blood pressure. Less is known about the eating patterns of special populations, such as those at risk for hypertension, or how demographic factors affect the diets of these populations. This article characterizes the usual diets of participants before they enrolled in the Dietary Approaches to Stop Hypertension (DASH) trial. During screening for DASH, 380 participants completed the National Cancer Institute food frequency questionnaire. Nutrient and food group intake, the Keys score (a measure of a diets atherogenicity), and the Diet Quality Index were estimated from the food frequency questionnaire. The effects of age, sex, race, baseline weight, and education on these dietary factors were assessed among DASH participants and compared with similar data from the Third National Health and Nutrition Examination Survey and other published reports. Among DASH participants, African-Americans reported lower intakes of dairy products (P < .001), calcium (P < .001), and magnesium (P < .05) than did whites. Older women reported greater intakes of calcium, magnesium, and potassium (all P < .05) and less fat (P < .05) than did younger women. Older men consumed fewer servings of fruits (P < .03), less vitamin C (P < .05), and had a higher Keys score (P < .05) than did younger men. Heavier (body mass index > or = 25) participants reported lower intakes of protein and potassium, but higher fat and energy intakes (all P < .05). Taken together, these data show that younger, overweight African-American women have the least healthful diets, because they consume more atherogenic foods and fewer of the nutrients related to decreased blood pressure. Overall Diet Quality Index scores did not differ between African-American and white participants. Despite differences in dietary assessment methods between the population samples of DASH and the Third National Health and Nutrition Examination Survey, within each population sample patterns of micronutrient intake were similar between African-American and white participants.

Diet Design for a Multicenter Controlled Feeding Trial

OBJECTIVE To describe the process and results of diet standardization, diet validation, and monitoring of diet composition, which were key components of protocol 1 of Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA-1), the initial protocol in a program of multicenter human feeding studies designed to evaluate the effects of amount and type of fat on lipoproteins and hemostasis parameters in various demographic groups. DESIGN DELTA-1 was based on a randomized, blinded, crossover experimental design. Three diets were fed for 8 weeks to 103 healthy men and women aged 22 to 67 years at 4 field centers. Diet A, an average American diet, was designed to provide 37% of energy from fat, 16% of energy from saturated fatty acids (SFAs); diet B (step 1 diet) was designed to provide 30% of energy from fat, 9% of energy from SFA; and diet C (low SFA diet) was designed to provide 26% of energy from fat, 5% of energy from SFA. Key features of diet standardization included central procurement of fat-containing foods, inclusion of standard ingredients, precision weighing of foods--especially sources of fat and cholesterol--and use of standardized written procedures. SETTING For menu validation, a set of 12 menus for each diet was prepared in duplicate and chemically assayed. For monitoring of diet composition during the study, an 8-day diet cycle (6 weekday and 2 weekend menus) was sampled by every field center twice during each of 3 feeding periods. STATISTICAL ANALYSES Means (+/- standard error) were calculated and compared with target nutrient specifications. RESULTS DELTA-1 was able to provide a standardized diet that met nutrient specifications across 4 field centers over 24 weeks of participant feeding spanning a total of 8 months. APPLICATIONS Prestudy chemical validation of menus and continuous sampling and assay of diets throughout the study are essential to standardize experimental diets and to ensure that nutrient target goals are met and maintained throughout a controlled multicenter feeding study.