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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Peter T. Katzmarzyk, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00945633
First received: July 22, 2009
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dietary, Physiological, Genetic, and Behavioral Predictors of Health in a Young, Ethnically-Mixed Population

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Identify relationships among the determinants of unhealthy weight gain that contribute to an individual's susceptibility to obesity. [ Time Frame: Ongoing over 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Archival repository


Estimated Enrollment: 1200
Study Start Date: June 2008
Estimated Study Completion Date: August 2023
Estimated Primary Completion Date: August 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts
African-american male, no obese parent
White male, no obese parent
African American Female, no obese parent
White female, no obese parent
African-American male, one obese parent
African Amer. female, one obese parent
White male, one obese parent
White female, one obese parent
African American male, two obese parents
African Amer. female, two obese parents
White male, two obese parents
White female, two obese parents

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Pennington Biomedical Research Center

Additional 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: PBRC27036
Study First Received: July 22, 2009
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Obesity
unhealthy weight gain

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014