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NCT Number: NCT02246933

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

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.

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Key information

Conditions

Inflammation Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Georgia - Department of Foods and Nutrition

Athens, Georgia, 30602, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PUFA Diet

Other

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

Other

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 outcomes

  1. Change in Blood Markers

    Time frame: Change measures baseline and 9 days

    Change in inflammation and coagulation factors

Secondary outcomes

  1. Change in Energy Expenditure

    Time frame: Change measures baseline and 9 days

  2. Change in Substrate Oxidation

    Time frame: Change measures baseline and 9 days

  3. Change in Fasting Blood Lipids

    Time frame: Change measures baseline and 9 days

  4. Change in Systolic Blood Pressure

    Time frame: Change measures baseline and 9 days

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2014
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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