Effects of a PUFA-rich Diet on Acute Metabolic and Inflammatory High-Fat Meal Responses

Obesity Clinical Trial

Official title:

Effects of a PUFA-rich Diet on Acute Metabolic and Inflammatory High-Fat Meal Responses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246933
• Other study ID #: 503815
• Status: Completed
• Phase: N/A
• First received: September 18, 2014
• Last updated: October 6, 2015
• Start date: September 2013
• Est. completion date: August 2015

Study information

• 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

Clinical Trial Summary

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.

Description:

Eating more saturated fats has been shown to decrease how many calories an individual burns and increase chronic disease risk by increasing inflammation, coagulation (blood clotting) potential, blood pressure, and cholesterol. Conversely, eating more poly-unsaturated fats has been linked to decreased risk of chronic diseases. The goal of this study is to determine whether or not eating a diet containing a lot of poly-unsaturated fats can compensate for the damaging effects of eating occasional high-fat meals that are high in saturated fats. Those damaging effects we are interested in studying include how much fat and calories a person's body burns, and measuring some markers of chronic disease risk in the blood (inflammation markers and blood clotting markers).

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammation
• Obesity

Intervention

Other:
• PUFA Diet
The 7-day diet will consist of 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.
• Control Diet
The 7-day diet will consist of 50% carbohydrate, 35% fat, and 15% protein. Furthermore, 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.

Locations

Country	Name	City	State
United States	University of Georgia - Department of Foods and Nutrition	Athens	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

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