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View Clinical Trial (Medical Research Study)
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Dietary, Physiological, Genetic, and Behavioral Predictors of Health in a Young, Ethnically-Mixed Population - NCT00945633-70808 (Clinical Trial 303244)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy303244.aspx
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| City: |
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Baton Rouge |
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State:
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LA |
| Zip Code: |
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70808 |
| Conditions: |
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Obesity |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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. |
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| Study is available at: |
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Pennington Biomedical Research Center
Baton Rouge, LA 70808
United States
Primary Contact:
Steven Smith, MD
Email: doctors@pbrc.edu
Secondary Contact:
Steven R Smith, M.D.
Email: Doctors@pbrc.edu
Phone: 225-763-3028 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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