Weight Loss and Cardiovascular Disease (CVD) Prevention Via a Whole Grain Diet in Men and Women With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Syndrome; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to determine if intake of whole grain foods as part of a
      hypocaloric diet enhances weight loss and improves cardiovascular disease risk factors in men
      and women with metabolic syndrome.
    

Detailed description: 
      Fifty men and women with metabolic syndrome age 20 to 65 will be recruited to participate.
      Men and women are eligible if they have a body mass index (BMI) ≥ 30 and at least three out
      of five ATP III criteria for metabolic syndrome. These criteria are defined as: [1]
      Triacylglycerol ≥150 mg/dL, [2] HDL <40 mg/dL in men or <50 mg/dL in women, [3] Fasting
      glucose ≥100 mg/dL, [4] Systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure
      ≥85 mg/dL, and [5] waist circumference ≥102 cm in men or ≥88 cm in women.

      Participants will receive dietary advice to either avoid whole grain foods or to have all of
      their grain servings each day from whole grain foods for 12 weeks. Participants will be
      stratified by gender and BMI and randomized using a random number table. A registered
      dietitian will meet individually with each participant at baseline to discuss the dietary
      intervention and provide educational materials. Participants in the whole grain group are
      given a target number of daily whole grain servings, either 4, 5, 6 or 7 servings/d, based on
      the number of grain servings recommended in the 2005 Dietary Guidelines For Americans for
      their energy needls to facilitate understanding and adherence. Participants in the whole
      grain group are given a list and description of whole grain foods to help them identify foods
      to include in their diet and were encouraged to select foods that had a whole grain food
      listed as the first ingredient. To ease the transition, participants in the whole grain group
      will consume three servings of whole grain foods per day for the first two weeks of the study
      and then increase to their target number of daily whole grain servings for the remaining ten
      weeks. Participants in the refined grain group are also given a list of whole grain foods and
      asked not to consume any of these foods during the study period.

      In addition to the instruction on whole grain servings, participants in both groups are
      aasked to eat five servings of fruit and vegetables, three servings of low-fat dairy
      products, and two servings of lean meat, fish or poultry/d, as recommended in the 2005
      Dietary Guidelines for Americans. The target macronutrient composition for all participants
      is 55% carbohydrate, 30% fat, with emphasis on unsaturated fats, and 15% protein. All
      participants are encouraged to engage in moderate physical activity at least three times a
      week for 30 minutes per session and were instructed to avoid dietary supplements throughout
      the study period. Participants in both groups are told that their aim was to lose at least 1
      pound per week for the duration of the study.

      Every other week, participants visit the study site and review their diet records with a
      dietitian on a one-on-one basis. During this time, the dietitian presents an educational
      lesson that explained the rationale for the dietary guidelines used in the study, and offered
      nutritional guidance, encouragement, and suggestions for improvement. The participant's
      weight, blood pressure, and waist circumference are also recorded. On the weeks that
      participants do not come in for a study visit, they are contacted by phone or e-mail by a
      dietitian to discuss their progress and address any concerns or questions. A fasting blood
      draw, 2-hour oral glucose tolerance test (OGTT), dual energy x-ray absorptiometery (DXA)
      scan, and biometric measurements are done at the beginning and end of the 12-week diet period
      at The Pennsylvania State University General Clinical Research Center (GCRC).
    

Intervention name(s): Whole Grain Foods
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: whole grain; metabolic syndrome; weight loss