NCT02246933

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

Enrollment Period

1.9 years

First QC Date

September 18, 2014

Last Update Submit

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

EXPERIMENTAL
Other: PUFA Diet

Control Diet

PLACEBO COMPARATOR
Other: Control Diet

Interventions

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.

PUFA 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.

Control Diet

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

MeSH Terms

Conditions

InflammationObesity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Study Officials

  • jamie A Cooper, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR

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

Locations