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

Primary Purpose

Inflammation, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PUFA Diet

Control Diet

About this trial

This is an interventional prevention trial for Inflammation

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Georgia - Department of Foods and Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PUFA Diet

Control Diet

Arm Description

Outcomes

Primary Outcome Measures

Change in Blood Markers

Change in inflammation and coagulation factors

Secondary Outcome Measures

Change in Energy Expenditure

Change in Substrate Oxidation

Change in Fasting Blood Lipids

Change in Systolic Blood Pressure

Full Information

NCT ID

NCT02246933

First Posted

September 18, 2014

Last Updated

October 6, 2015

Sponsor

University of Georgia

1. Study Identification

Unique Protocol Identification Number

NCT02246933

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Georgia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation, Obesity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PUFA Diet

Arm Type

Experimental

Arm Title

Control Diet

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

PUFA Diet

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Control Diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Blood Markers

Description

Change in inflammation and coagulation factors

Time Frame