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Weight Loss and Cardiovascular Disease (CVD) Prevention Via a Whole Grain Diet in Men and Women With Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole Grain Foods
Sponsored by
Penn State University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring whole grain, metabolic syndrome, weight loss

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • body mass index (BMI) ≥ 30
  • 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.

Exclusion Criteria:

  • diagnosis of type I or II diabetes
  • diagnosis of CVD
  • diagnosis of cancer
  • diagnosis of any other serious medical condition
  • use of any medications that affect glucose, insulin, cholesterol, or reproductive hormones
  • smoker
  • drink more than 2 alcoholic beverages/d
  • consume a diet high in whole grains (>3 servings/d)
  • pregnant or lactating

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Weight Loss

    Secondary Outcome Measures

    Waist Circumference
    Blood Pressure
    Body fat percentage
    Lipids and Lipoproteins
    Glucose Tolerance (OGTT)
    Testosterone Concentration
    Markers of Inflammation and Fibrinolysis

    Full Information

    First Posted
    March 30, 2007
    Last Updated
    August 16, 2023
    Sponsor
    Penn State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00455065
    Brief Title
    Weight Loss and Cardiovascular Disease (CVD) Prevention Via a Whole Grain Diet in Men and Women With Metabolic Syndrome
    Official Title
    Weight Loss and Cardiovascular Disease (CVD) Prevention Via a Whole Grain Diet in Men and Women With Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2005 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Penn State University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome
    Keywords
    whole grain, metabolic syndrome, weight loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Whole Grain Foods
    Primary Outcome Measure Information:
    Title
    Weight Loss
    Secondary Outcome Measure Information:
    Title
    Waist Circumference
    Title
    Blood Pressure
    Title
    Body fat percentage
    Title
    Lipids and Lipoproteins
    Title
    Glucose Tolerance (OGTT)
    Title
    Testosterone Concentration
    Title
    Markers of Inflammation and Fibrinolysis

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: body mass index (BMI) ≥ 30 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. Exclusion Criteria: diagnosis of type I or II diabetes diagnosis of CVD diagnosis of cancer diagnosis of any other serious medical condition use of any medications that affect glucose, insulin, cholesterol, or reproductive hormones smoker drink more than 2 alcoholic beverages/d consume a diet high in whole grains (>3 servings/d) pregnant or lactating
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Penny M Kris-Etherton, Ph.D.
    Organizational Affiliation
    Penn State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18175740
    Citation
    Katcher HI, Legro RS, Kunselman AR, Gillies PJ, Demers LM, Bagshaw DM, Kris-Etherton PM. The effects of a whole grain-enriched hypocaloric diet on cardiovascular disease risk factors in men and women with metabolic syndrome. Am J Clin Nutr. 2008 Jan;87(1):79-90. doi: 10.1093/ajcn/87.1.79.
    Results Reference
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