Effects of a PUFA-rich Diet on Acute Metabolic and Inflammatory High-Fat Meal Responses
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 18, 2014
CompletedFirst Posted
Study publicly available on registry
September 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedOctober 8, 2015
October 1, 2015
1.9 years
September 18, 2014
October 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Blood Markers
Change in inflammation and coagulation factors
Change measures baseline and 9 days
Secondary Outcomes (4)
Change in Energy Expenditure
Change measures baseline and 9 days
Change in Substrate Oxidation
Change measures baseline and 9 days
Change in Fasting Blood Lipids
Change measures baseline and 9 days
Change in Systolic Blood Pressure
Change measures baseline and 9 days
Study Arms (2)
PUFA Diet
EXPERIMENTALControl Diet
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Georgia - Department of Foods and Nutrition
Athens, Georgia, 30602, United States
Related Publications (1)
Kaviani S, Taylor CM, Stevenson JL, Cooper JA, Paton CM. A 7-day high-PUFA diet reduces angiopoietin-like protein 3 and 8 responses and postprandial triglyceride levels in healthy females but not males: a randomized control trial. BMC Nutr. 2019 Jan 6;5:1. doi: 10.1186/s40795-018-0262-7. eCollection 2019.
PMID: 32153916DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jamie A Cooper, PhD
University of Georgia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 18, 2014
First Posted
September 23, 2014
Study Start
September 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
October 8, 2015
Record last verified: 2015-10