Overview

This trial is active, not recruiting.

Condition obesity
Sponsor Pennington Biomedical Research Center
Start date June 2008
End date August 2023
Trial size 1200 participants
Trial identifier NCT00945633, PBRC 27036

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Identify dietary, physiological, genetic and behavioral determinants of unhealthy weight gain over a ten-year period in healthy, young, ethnically-mixed men and women with no, one, or two obese parents.
time frame: Annually over 10 years

Secondary Outcomes

Measure
Identify relationships between genetic measures of taste perception and the determinants of unhealthy weight gain in the said population.
time frame: Baseline, Year 5, and Year 10
Identify relationships among the determinants of unhealthy weight gain that contribute to an individual's susceptibility to obesity.
time frame: Ongoing over 10 years

Eligibility Criteria

Male or female participants from 20 years up to 35 years old.

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.

Additional Information

Official title Dietary, Physiological, Genetic, and Behavioral Predictors of Health in a Young, Ethnically-Mixed Population
Principal investigator Peter Katzmarzyk, Ph.D.
Description OBJECTIVES 1. Identify dietary, physiological, genetic and behavioral determinants of unhealthy weight gain over a ten-year period in healthy, young, ethnically-mixed men and women with no, one, or two obese parents. This will be a large-scale, prospective, longitudinal, clinical study using an epidemiological approach. The 1200, free-living participants age 20-35 will be equally divided by gender and race (Caucasian and African-American). Among the participants, 1/3 will have no obese parent, 1/3 will have one obese parent, and 1/3 will have two obese (body mass index, BMI > 30 kg/m2) parents. The participants will undergo a series of assessments in the domains of diet, physiological factors, and behavioral factors at baseline and every 12 months thereafter (unless otherwise noted in Approach and Research Procedures) for 10 years. 2. Identify relationships between genetic measures of taste perception and the determinants of unhealthy weight gain in the said population. Participants will be classified based on 6-n-propylthiouracil (PROP) status (non-taster, taster, super taster) and fat taste preference. Statistical relationships between genetic measures of taste perception, fat taste preference, dietary intake, physiological status, and behavioral factors will be determined. 3. Identify relationships among the determinants of unhealthy weight gain that contribute to an individual's susceptibility to obesity. Advanced longitudinal and multivariate statistical and epidemiological techniques will be used to identify and model underlying correlation structures among the measurements collected by the research team pertaining to sensory perception, diet, biological factors (energy expenditure, insulin sensitivity and secretion, detailed body composition, skeletal muscle metabolism, adipocyte factors, genetics), cognitive factors (dietary restraint, disinhibition, food adventurousness), behavior, demographics, and other possible contributing factors to unhealthy weight gain over time.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Pennington Biomedical Research Center.