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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 19, 2006 | ||||
| Last Updated Date | August 24, 2009 | ||||
| Start Date ICMJE | April 1999 | ||||
| Estimated Primary Completion Date | January 2004 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00342732 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Food Intake Phenotype: Assessing Eating Behavior and Food Preferences as Risk Factors for Obesity | ||||
| Official Title ICMJE | The Food Intake Phenotype: Assessing Eating Behavior and Food Preferences as Risk Factors for Obesity | ||||
| Brief 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. |
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| Detailed Description | 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. As food intake influences appetite-regulating hormones and vice versa, we also plan to assess the effect of short-term overfeeding on ad libitum intake and the appetite-stimulating hormone, ghrelin. Also, as the body's metabolism of carbohydrates may influence food intake, we propose to look at the effects of isocaloric high fat and high carbohydrate diets on short-term ad libitum intake. We will study Pima Indians and 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 480 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | January 2004 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Healthy, as determined by medical history, physical examination, and laboratory tests. Diabetic, if recently diagnosed (within the last 6 months) and not taking any diabetes medications (original study only). EXCLUSION CRITERIA: Hypo or hyper thyroid Blood pressure greater than 160/95 Cardiovascular disease Gallbladder disease Alcohol and/or current use of drugs (more than 2 drinks per day and regular use of drugs such as amphetamines, cocaine, heroin, or marijuana) 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 Use of medications affecting metabolism and appetite Pregnancy Smoking Diabetes diagnosis (overfeeding study arm and macronutrient study arm). |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00342732 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 999999019, OH99-DK-N019 | ||||
| Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE | |||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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