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

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ClinicalTrials.gov Identifier: NCT02246933
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Jamie Cooper, University of Georgia

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.

Condition or disease Intervention/treatment Phase
Inflammation Obesity Other: PUFA Diet Other: Control Diet Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of a PUFA-rich Diet on Acute Metabolic and Inflammatory High-Fat Meal Responses
Study Start Date : September 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: PUFA Diet 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.

Placebo Comparator: Control Diet Other: 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.




Primary Outcome Measures :
  1. Change in Blood Markers [ Time Frame: Change measures baseline and 9 days ]
    Change in inflammation and coagulation factors


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246933


Locations
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United States, Georgia
University of Georgia - Department of Foods and Nutrition
Athens, Georgia, United States, 30602
Sponsors and Collaborators
University of Georgia
Investigators
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Principal Investigator: jamie A Cooper, PhD University of Georgia

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Responsible Party: Jamie Cooper, Associate Professor, University of Georgia
ClinicalTrials.gov Identifier: NCT02246933     History of Changes
Other Study ID Numbers: 503815
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes