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

August 21, 2025 updated by: Peter T. Katzmarzyk, Pennington Biomedical Research Center

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

90

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
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research 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

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The sample includes 90 free-living participants aged 20-35 years.

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body weight
Time Frame: Annually over 2 years
Changes in body weight (kg) from baseline
Annually over 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in fat mass
Time Frame: Annually over 2 years
Changes in fat mass (kg) from baseline
Annually over 2 years

Collaborators and Investigators

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

Sponsor

Pennington Biomedical Research Center

Investigators

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

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

June 1, 2008

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

July 22, 2009

First Submitted That Met QC Criteria

July 23, 2009

First Posted (Estimated)

July 24, 2009

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 27036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Obesity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe