Role of Polyunsaturated Fatty Acids (PUFA)-Gene Interactions in Heath Disparities

January 14, 2022 updated by: Wake Forest University Health Sciences

Role of PUFA-Gene Interactions in Health Disparities

A randomized, clinical trial to provide the first comprehensive investigation of the role of fatty acid desaturate (FADS) genetic determinants on PUFA biosynthesis and metabolism as well as levels of inflammatory markers in a controlled dietary environment using two (low and high linoleic acid) parallel diets.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be provided (weekly) with food items containing most of (>90%) the daily dietary fat (25-30% of daily calories) to be consumed. All study-supplied foods will be prepared by or acquired by the Wake Forest University Health Sciences (WFUHS) Clinical Research Unit (CRU) Metabolic Kitchen and distributed by the same. These foods will include smoothies (containing flaxseed oil common to both arms), and arm-dependent oil-based condiments (salad dressing, mayonnaise, and margarine) and prepared snack foods, each made with the arm-specific oil, as well as several packaged snacks and food items. Participants will be provided meal plans and recipes for home preparation of meals that will allow them to adhere to the target fatty acid contents of the two dietary arms. The goal of the dietary intervention is to provide participants with the daily fat content of their diet (25-30% of the daily calories) and to educate the participant to select and consume the balance of nutrients (60-75% of daily calories) derived from non-fat/low-fat containing foods.

Study Type

Interventional

Enrollment (Actual)

80

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

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Wake Forest Baptist Medical Center

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

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to give informed consent
  • Must agree to adhere to dietary intervention requirements during the entire 12-week study period
  • Be willing to participate for the whole study
  • Agree not to take any PUFA-based dietary supplements during the study
  • Agree not to take interfering medications during the duration of the study
  • Agree to allow samples to be stored for future use
  • Self-identify as European American or African American

Exclusion Criteria:

  • A diagnosis of diabetes, cancer, heart disease, arthrosclerosis, asthma, multiple sclerosis or chronic joint disease or the occurrence heart attack or vascular surgery within the past year, untreated high blood pressure or a history of stroke, having a pacemaker or a defibrillator
  • use of tobacco products (smoked, smokeless, electronic) within the last six months
  • Currently pregnant or lactating. Potential female subjects are asked in the telephone screening if they are pregnant or plan to become pregnant in the next year. Those answering in the affirmative are excluded. We will include in the Institutional Review Board (IRB) protocol and consent that subjects agree to use a reliable method of birth control during the time they are in the study.
  • Having a current or recent history of eating disorders
  • Having an allergy to safflower or, flaxseed or olive oils.
  • fasting triglycerides (TG) greater than 150 mg/dl, as measured by Lab Corp at screening
  • BP greater than 140/90 , as measured by a CRU nurse, at screening
  • BMI equal to or greater than 30 or less than 19, as measured at screening
  • fasting glucose greater than 125 mg/dl, as measured by Lab Corp at screening
  • use of aspirin (>100 mg /day), NSAIDS or oral corticosteroids
  • use of montelukast-type of allergy medications
  • use of statins, niacin or fibrates or other lipid lowering medications
  • use of botanical/fish (PUFA-containing) oil or dietary supplements for one month prior to joining the study .
  • individuals not self-identifying as European American or African American
  • individuals self-identifying as Hispanic
  • Individuals of vulnerable populations, including children, will not be recruited for this study
  • having an hsCRP measurement in excess of 3.0 at Visit 1

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High Linoleic Acid (LA) Diet
European Americans (genotypes: TT, GT & GG) and African Americans (genotypes: GT & GG) at rs173537will be randomly assigned to a high LA diet (10% energy) based on a randomized block design with 5 strata defined by race and genotype combinations.
Dietary supplement: High Linoleic Acid (LA) Diet
Volunteers will be randomly assigned to consumption of a high [10% energy] LA-containing diet for 12 weeks.
EXPERIMENTAL: Low Linoleic Acid (LA) Diet
European Americans (genotypes: TT, GT & GG) and African Americans (genotypes: GT & GG) at rs173537will be randomly assigned to a low LA diet (2.5% energy) based on a randomized block design with 5 strata defined by race and genotype combinations.
Dietary supplement: Low Linoleic Acid (LA) Diet
Volunteers will be randomly assigned to consumption of a low [2.5% energy] LA-containing diet for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement in Change of PUFAs
Time Frame: 12 Weeks for Each Volunteer
The primary outcome is the measurement of the change in PUFAs at 12 weeks. Biological specimens (urine and blood) will be collected from each subject at the beginning of the dietary intervention and at 4 week intervals. The primary outcome will be the measured difference between baseline and final PUFA levels before and after the diet.
12 Weeks for Each Volunteer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Change in Serum Lipids (Cholesterol and Triglycerides)
Time Frame: 12 Weeks for Each Volunteer
Secondary outcomes will be quantified in mg/dL and assessed using standard methods in an accredited clinical laboratory.
12 Weeks for Each Volunteer

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Change in Inflammatory Biomarkers (including Cytokines)
Time Frame: 12 Weeks for Each Volunteer
The biochemical endpoints will be measured using established protocols
12 Weeks for Each Volunteer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Center for Complementary and Integrative Health (NCCIH)
University of Arizona
Office of Dietary Supplements (ODS)

Investigators

  • Principal Investigator: Susan Sergeant, PhD, Wake Forest University Health Sciences

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.

General Publications

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 (ACTUAL)

November 29, 2016

Primary Completion (ACTUAL)

December 14, 2021

Study Completion (ACTUAL)

December 14, 2021

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (ESTIMATE)

November 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00038046
  • 1R01AT008621-01A1 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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