- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02246933
Effects of a PUFA-rich Diet on Acute Metabolic and Inflammatory High-Fat Meal Responses
October 6, 2015 updated by: Jamie Cooper, University of Georgia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30602
- University of Georgia - Department of Foods and Nutrition
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Blood Markers
Time Frame: Change measures baseline and 9 days
|
Change in inflammation and coagulation factors
|
Change measures baseline and 9 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Energy Expenditure
Time Frame: Change measures baseline and 9 days
|
Change measures baseline and 9 days
|
Change in Substrate Oxidation
Time Frame: Change measures baseline and 9 days
|
Change measures baseline and 9 days
|
Change in Fasting Blood Lipids
Time Frame: Change measures baseline and 9 days
|
Change measures baseline and 9 days
|
Change in Systolic Blood Pressure
Time Frame: Change measures baseline and 9 days
|
Change measures baseline and 9 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jamie A Cooper, PhD, University of Georgia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
September 18, 2014
First Submitted That Met QC Criteria
September 18, 2014
First Posted (Estimate)
September 23, 2014
Study Record Updates
Last Update Posted (Estimate)
October 8, 2015
Last Update Submitted That Met QC Criteria
October 6, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 503815
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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