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

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ClinicalTrials.gov Identifier: NCT02962128
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : November 20, 2020
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
University of Arizona
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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
Fatty Acid-Gene Interactions Dietary Supplement: High Linoleic Acid (LA) Diet Dietary Supplement: Low Linoleic Acid (LA) Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 : November 29, 2016
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Measurement of Change in Inflammatory Biomarkers (including Cytokines) [ Time Frame: 12 Weeks for Each Volunteer ]
    The biochemical endpoints will be measured using established protocols



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962128


Contacts
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Contact: Tammy L Mustin, MS 336-716-7388 talee@wakehealth.edu
Contact: Priscilla Ivester, MS 336-716-7388 Ivester@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Priscilla Ivester    336-716-7388      
Contact: Tammy Mustin    336-716-7388      
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
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Principal Investigator: Susan Sergeant, PhD Wake Forest University Health Sciences
Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02962128    
Other Study ID Numbers: IRB00038046
1R01AT008621-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No