InSight: Dietary, Physiological, Genetic, and Behavioral Predictors of Health in a Young, Ethnically-Mixed Population

Sponsor
Pennington Biomedical Research Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00945633
Collaborator
(none)
90
1
182
0.5

Study Details

Study Description

Brief Summary

Dietary intervention and other strategies to prevent unhealthy weight gain and the development of obesity should be based on knowledge of dietary, physiological, genetic and behavioral determinants and their contributing interactions. Identifying these determinants is difficult because physiological susceptibility to specific dietary and behavioral factors implicated in unhealthy weight gain differs between populations and individuals within the populations. The research challenge is identifying specific determinants in a free-living, adult population.

Understanding the interaction between diet and the underlying susceptibility factors such as physiologic, genetic and epigenetic, and behavioral factors mandate an integrated approach.

This integrated approach should include understanding the interplay of physiological factors (genetics, epigenetics, taste preferences, susceptibility to energy excess, etc.) and behavioral factors (food cravings, restraint, disinhibition, physical activity) as each of these domains is a potential driving force in energy expenditure, food preference, dietary choices, and food intake.

Which of these factor(s) is most important? The investigators propose that by examining dietary, physiological, genetic, and behavioral factors in an integrated fashion we will gain insight into the obesity epidemic and identify the most important determinants of weight gain. As a secondary aim, the investigators will identify a single parsimonious collection of factors and develop strategies to mitigate the risks of developing obesity.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a prospective, longitudinal, clinical study using an epidemiological approach. The sample consists of 90 free-living participants aged 20-35 years. The participants will undergo a series of assessments in the domains of diet, physiological factors, and behavioral factors at baseline and every 12 months for 2 years.

    OBJECTIVES

    1. Identify dietary, physiological, genetic and behavioral determinants of unhealthy weight gain in healthy, young, ethnically-mixed men and women.

    2. Identify relationships between genetic measures of taste perception and the determinants of unhealthy weight gain in the said population.

    3. Identify relationships among the determinants of unhealthy weight gain that contribute to an individual's susceptibility to obesity.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Dietary, Physiological, Genetic, and Behavioral Predictors of Health in a Young, Ethnically-Mixed Population
    Study Start Date :
    Jun 1, 2008
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Changes in body weight [Annually over 2 years]

      Changes in body weight (kg) from baseline

    Secondary Outcome Measures

    1. Changes in fat mass [Annually over 2 years]

      Changes in fat mass (kg) from baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Inclusion criteria will be healthy men and women between the ages of 20-35, with BMI < 27.5 kg/m2, and fasting blood glucose < 126 mg/dl.
    Exclusion Criteria:
    • History of diabetes, history of obesity (BMI > 30).

    • History of known inherited medical conditions that might influence future health status.

    • Current or planned medication usage that might influence future health status.

    • Prior serious injuries/surgeries that might influence future health status.

    • Women who are pregnant or breastfeeding (once enrolled, pregnancy will not cause subjects to be terminated from the study).

    • Women who are < 6 months postpartal, or women who have discontinued breastfeeding < 3 months prior to screening.

    • History of cancer (including skin cancer) within 5 years.

    • History or organ transplant.

    • Previous diagnosis with HIV, Hepatitis B or C, or tuberculosis.

    • Abuse of alcohol or illegal drugs.

    • Abnormal EKG.

    • Presence of pacemaker, defibrillator, or implanted metal.

    • History of eating disorders and abnormal psychological scores for the screening measures described under Psychological Assessment Measures in the Appendix. This psychological screening will be conducted approximately two weeks prior to outpatient testing.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808

    Sponsors and Collaborators

    • Pennington Biomedical Research Center

    Investigators

    • Principal Investigator: Peter Katzmarzyk, Ph.D., Pennington Biomedical Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peter T. Katzmarzyk, Principal Investigator, Pennington Biomedical Research Center
    ClinicalTrials.gov Identifier:
    NCT00945633
    Other Study ID Numbers:
    • PBRC 27036
    First Posted:
    Jul 24, 2009
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Peter T. Katzmarzyk, Principal Investigator, Pennington Biomedical Research Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2022