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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02962128
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH), Office of Dietary Supplements (ODS) (NIH), University of Arizona (Other)
80
Enrollment
1
Location
2
Arms
60.5
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: High Linoleic Acid (LA) Diet
  • Dietary Supplement: Low Linoleic Acid (LA) Diet
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Role of PUFA-Gene Interactions in Health Disparities
Actual Study Start Date :
Nov 29, 2016
Actual Primary Completion Date :
Dec 14, 2021
Actual Study Completion Date :
Dec 14, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Measurement in Change of PUFAs [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.

Secondary Outcome Measures

  1. Measurement of Change in Serum Lipids (Cholesterol and Triglycerides) [12 Weeks for Each Volunteer]

    Secondary outcomes will be quantified in mg/dL and assessed using standard methods in an accredited clinical laboratory.

Other Outcome Measures

  1. Measurement of Change in Inflammatory Biomarkers (including Cytokines) [12 Weeks for Each Volunteer]

    The biochemical endpoints will be measured using established protocols

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest Baptist Medical Center Winston-Salem North Carolina United States 27103

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT02962128
Other Study ID Numbers:
  • IRB00038046
  • 1R01AT008621-01A1
First Posted:
Nov 11, 2016
Last Update Posted:
Jan 31, 2022
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 31, 2022