Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455065
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2007-03-30
Brief Title:
Weight Loss and Cardiovascular Disease CVD Prevention Via a Whole Grain Diet in Men and Women With Metabolic Syndrome
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
Weight Loss and Cardiovascular Disease CVD Prevention Via a Whole Grain Diet in Men and Women With Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgdL 2 HDL 40 mgdL in men or 50 mgdL in women 3 Fasting glucose 100 mgdL 4 Systolic blood pressure 130 mmHg andor diastolic blood pressure 85 mgdL 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 servingsd 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 poultryd 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 participants 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
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 servingsd 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 poultryd 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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None