Obesity Clinical Trial
Official title:
Effects of a PUFA-rich Diet on Acute Metabolic and Inflammatory High-Fat Meal Responses
Verified date | October 2015 |
Source | University of Georgia |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This study evaluates whether a diet rich in poly-unsaturated fats can compensate for the negative effects of high saturated fat meals on metabolic, inflammatory, and coagulation responses. Half of the participants will receive a high polyunsaturated fat diet )50% carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids) for 7 days, while the other half will receive a control diet 50% carbohydrate, 35% fat, and 15% protein 50% carbohydrate, 35% fat, and 15% protein. Only, 7% of total energy will be poly-unsaturated fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total energy will be saturated fatty acids.) for 7 days.
Status | Completed |
Enrollment | 26 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Apparently healthy men and women between the ages of 18 and 45y with a normal weight based on body mass index (BMI=18-24.9kg/m2), must be sedentary (perform less than 3 hours per week of structured exercise) and , if participant has fasting total cholesterol >200 gm/dL, high-density lipoprotein <40 mg/dL, low-density lipoprotein cholesterol >100 mg/dL, and/or triglycerides >150 mg/dL (based on fasting blood lipids). Exclusion Criteria: - Weight loss or gain exceeding 5% of body weight in the past 3 months - Current participation in a weight loss program - Any current exercisers (greater than 3h per week) - Any person who is on a medically prescribed diet - Any person who is vegan, or any type of vegetarian other than pesco-vegetarian - Any chronic or metabolic disease, hyperlipidemia, gastrointestinal disorder, or history of medical or surgical events that could affect digestion and absorption of nutrients - Any current supplement use other than a daily multivitamin (this includes fish oil supplements) - Any current medication use other than birth control (this includes anti-inflammatory NSAID use). - Anyone who is pregnant, lactating, or planning a pregnancy - Anyone who has donated blood or plasma in the last 20 days - Any tobacco users - Anyone who has allergies to the most common food allergens (milk, eggs, peanuts, almonds, cashews, walnuts, fish, shellfish, soy and wheat) or to any of the food that will provided during the study - Anyone who has allergies to any of the components of the liquid meals |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Georgia - Department of Foods and Nutrition | Athens | Georgia |
Lead Sponsor | Collaborator |
---|---|
University of Georgia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Blood Markers | Change in inflammation and coagulation factors | Change measures baseline and 9 days | No |
Secondary | Change in Energy Expenditure | Change measures baseline and 9 days | No | |
Secondary | Change in Substrate Oxidation | Change measures baseline and 9 days | No | |
Secondary | Change in Fasting Blood Lipids | Change measures baseline and 9 days | No | |
Secondary | Change in Systolic Blood Pressure | Change measures baseline and 9 days | No |
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