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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00342732
Other study ID # 999999019
Secondary ID OH99-DK-N019
Status Recruiting
Phase
First received
Last updated
Start date November 24, 1999

Study information

Verified date February 28, 2024
Source National Institutes of Health Clinical Center (CC)
Contact Kat A Ware
Phone (602) 200-5300
Email wareka@mail.nih.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The prevalence of obesity in the United States has reached alarming proportions with 33% of adults over the age of 20 being overweight. Obesity is more than twice as prevalent, however, in the Pima Indians of Arizona. Although there have been a number of advances in our understanding of the genetics of obesity, the environmental influences on the genetic expression of obesity requires further investigation. In an effort to understand some of the influences on the high prevalence of obesity in the Pima Indians, the present study was designed to investigate eating behaviors and food preferences, most especially the preference for high fat foods, in sib-pairs of Pima Indians who have been previously genotyped in our genomic scan for loci linked to diabetes/obesity. Most specifically, we will utilize several questionnaires and methods of assessing eating behavior and the preference for high fat foods to create a food intake phenotype. In addition, we will study Caucasians so that comparisons can be made between these two groups. We will make these evaluations by assessing eating behavior, food preferences including usual fat intake and preferences for high fat foods, body image perceptions, and energy expenditure. It is hoped that the data gathered from this study will elucidate some of the risk factors for the development of obesity among the Pima Indians.


Description:

The prevalence of obesity in the United States has reached alarming proportions with 33% of adults over the age of 20 being overweight. In some populations, obesity is even more prevalent. Although there have been a number of advances in our understanding of the genetics of obesity, the environmental influences on the genetic expression of obesity requires further investigation. In an effort to understand some of the influences on the high prevalence of obesity, the present study was designed to investigate what drives how much people eat. More specifically, we will try to understand what drives food intake utilizing 1) questionnaires that assess eating behavior, 2) measurements in blood, urine or fat tissue, and 3) genotypic associations to investigate the various factors that control what and how much people eat. We will make these evaluations by assessing eating behavior, food preferences including usual fat intake and preferences for high fat foods, body image perceptions, and energy expenditure. It is hoped that the data gathered from this study will elucidate some of the risk factors for the development of obesity.


Recruitment information / eligibility

Status Recruiting
Enrollment 1140
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility - Inclusion Criteria: 1. Healthy, as determined by medical history, physical examination, and laboratory tests. 2. 18-65 years old 3. Non-diabetic status Exclusion Criteria: 1. Hypo- or hyper-thyroid 2. Blood pressure greater than 160/95 3. Cardiovascular disease 4. Gallbladder disease 5. Alcohol and/or current use of drugs (more than 2 drinks per day and regular use of drugs such as amphetamines, cocaine, or heroin) 6. Psychiatric conditions or behavior that would be incompatible with safe and successful participation in this study, including claustrophobia and eating disorders such as anorexia or bulimia nervosa 8. Use of medications affecting metabolism and appetite 9. Pregnancy 10. Current use of nicotine products, including tobacco, electronic cigarettes, and nicotine replacement therapies Subjects may be excluded or withdrawn from the study if they have any conditions not specifically mentioned above that may interfere with the collection of the food intake. This includes such issues as not following study and unit policies and procedures, diagnosis of contraindications following admission, and development of illness/infection unrelated to the study. For example, volunteers who do not comply with the vending machine protocol (i.e., share food, do not record what they eat, eat outside of room, etc) may be withdrawn from the study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States NIDDK, Phoenix Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ad libitum food intake Ad libitum food intake measured in kcal/day averaged over 3 days Baseline, up to day 3
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