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

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ClinicalTrials.gov Identifier: NCT00945633
Recruitment Status : Active, not recruiting
First Posted : July 24, 2009
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Peter T. Katzmarzyk, Pennington Biomedical Research Center

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
Obesity

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
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 : June 2008
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023



Primary Outcome Measures :
  1. Changes in body weight [ Time Frame: Annually over 2 years ]
    Changes in body weight (kg) from baseline


Secondary Outcome Measures :
  1. Changes in fat mass [ Time Frame: Annually over 2 years ]
    Changes in fat mass (kg) from baseline


Biospecimen Retention:   Samples With DNA
Archival repository


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The sample includes 90 free-living participants aged 20-35 years.
Criteria

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.

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): NCT00945633


Locations
United States, Louisiana
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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter T. Katzmarzyk, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00945633     History of Changes
Other Study ID Numbers: PBRC 27036
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Peter T. Katzmarzyk, Pennington Biomedical Research Center:
Obesity
unhealthy weight gain