Status:
TERMINATED
Diet-Induced-Obesity Resistant Phenotypes in Humans
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
25-50 years
Brief Summary
Background: \- Obesity is the result of many factors, including genetics and lifestyle, such as over-eating high-calorie foods and not being physically active. Obesity affects approximately one third...
Detailed Description
While many obesity studies focus on the individuals who are already overweight and obese, a complementary approach to understand such a common disease is to define the mechanisms which allow some lean...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Healthy normal men and women between 25-50 years of age;
- BMI between 18.5 and 25.0 kg/M(2);
- Self-reported as having had trouble gaining weight, who doing little or no exercise, self-described or by friends or family members as an overeater, and who have never tried to lose weight.
- EXCLUSION CRITERIA:
- A self-reported history of overweight after the age of 18, other than during pregnancy for women;
- Recent weight changes \>2% of current body weight in the last 6 months;
- Current or past history of eating disorders such as binge eating, anorexia nervosa, or bulimia, by psychological evaluations;
- Current or past history of intentional weight loss by self-report, other than postpartum weight loss;
- High physically demanding occupations or volitional exercise \>20 total minutes/day of moderate intensity or higher (as measured by sweating), \>2 days/week, by self-report;
- Significant dietary limitations (multiple food allergies/intolerances, vegan diet, etc.) that may affect absorption and body weight, or special dietary requirements that are difficult to accommodate with by study diets;
- Significant physical limitations that may preclude completing the majority of the tests in this study;
- Current pregnancy, recent pregnancy (\<3 years), current/recent breast feeding (\<1 year), or perimenopausal status. During the study, women may be asked to use birth control and will undergo repeated pregnancy testing. Subjects who refuse these tests will be excluded;
- Current or past medical conditions that are known to affect energy metabolism and body weight regulations, including HIV/AIDS, cancer, cardiac ischemia, dyslipidemia, thyroid and parathyroid disorders, hypo- or hypertension, diabetes (type 1 or type 2) or impaired glucose tolerance, congenital or acquired lipodystrophy, hepatic, renal, neuromuscular, celiac disease and other malabsorptive conditions, known genetic disorders that alter lipid metabolism, or cardiac failure as assessed by history and physical exam;
- Any psychiatric condition (including psychosis) or personality disorder as judged by the PI or Co-PI that would impede participation in the study;
- Smoking (currently or within the past year), excessive caffeine (\>500 mg/day) and/or alcohol intake (\>2 drinks/day for men, \> 1 drink/day for women), as assessed by self reports and serum thiocyanate;
- Taking narcotics, cocaine, or marijuana which would alter metabolism (positive urine toxicology screen)
- Any use of medications or nutritional supplements known to increase EE, depress food intake, or affect absorption;
- Unwilling or unable to give informed consent;
- Any other clinical or sub-clinical conditions not mentioned above that are considered by the investigators as significant exclusions for the study.
Exclusion
Key Trial Info
Start Date :
September 19 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 22 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00999154
Start Date
September 19 2009
End Date
October 22 2012
Last Update
December 3 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892