ObesityNCT00342732
The Food Intake Phenotype: Assessing Eating Behavior and Food Preferences as Risk Factors for Obesity
An observational study of Obesity and Overweight, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight, Overnutrition
- How many people
- 539 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 1999to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Residents of Phoenix metropolitan area
Who may be able to join
- Healthy, as determined by medical history, physical examination, and laboratory tests.
- 18-65 years old
- Non-diabetic status
Who cannot join
- 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, or heroin)
- 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
Show all 10Show fewer
- 8. Use of medications affecting metabolism and appetite
- 9. Pregnancy
- 10. Current use of nicotine products, including tobacco, electronic cigarettes, and nicotine replacement therapies that exceed Very Low Dependence on the Fagerstr(SqrRoot)(Delta)m Test for Nicotine Dependence Tool (score greater than 2).
- Subjects may be excluded or withdrawn from the study if they have any conditions not specifically mentioned above that may interfere with the collection of the food intake.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.
Trial locations and contacts
1 site in 1 country.
About this study
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....
Read the 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. 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.
- Conditions
- Obesity, Overweight, Overnutrition
- Keywords
- Genetics, Fat Intake, Weight Control, Appetite Control, Natural History
- Medical subject headings
- Obesity, Overweight, Overnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| non-diabetic volunteers | non-diabetic volunteers aged 18-65 who are healthy as determined by medical history, physical examination, and laboratory tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum food intake
Ad libitum food intake measured in kcal/day averaged over 3 days
Measured: Baseline, up to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start24 Nov 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Susanne M Votruba, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342732
- Sponsor's protocol ID
- 999999019
- Other IDs
- OH99-DK-N019
- Status last verified
- 10 Sep 2026
- First submitted
- 19 Jun 2006
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aydin BN, Stinson EJ, Cabeza De Baca T, Ando T, Travis KT, Piaggi P, Krakoff J, Chang DC. Investigation of seasonality of human spontaneous physical activity and energy expenditure in respiratory chamber in Phoenix, Arizona. Eur J Clin Nutr. 2024 Jan;78(1):27-33. doi: 10.1038/s41430-023-01347-y. Epub 2023 Oct 13.
PubMed 37833567Booker JM, Chang DC, Stinson EJ, Mitchell CM, Votruba SB, Krakoff J, Gluck ME, Cabeza de Baca T. Food insecurity is associated with higher respiratory quotient and lower glucagon-like peptide 1. Obesity (Silver Spring). 2022 Jun;30(6):1248-1256. doi: 10.1002/oby.23437.
PubMed 35674698Cabeza de Baca T, Piaggi P, Gluck ME, Krakoff J, Votruba SB. Meal-to-meal and day-to-day macronutrient variation in an ad libitum vending food paradigm. Appetite. 2022 Apr 1;171:105944. doi: 10.1016/j.appet.2022.105944. Epub 2022 Jan 21.
PubMed 35074459Basolo A, Hollstein T, Shah MH, Walter M, Krakoff J, Votruba SB, Piaggi P. Higher fasting plasma FGF21 concentration is associated with lower ad libitum soda consumption in humans. Am J Clin Nutr. 2021 Oct 4;114(4):1518-1522. doi: 10.1093/ajcn/nqab204.
PubMed 34159373Basolo A, Ando T, Chang DC, Hollstein T, Krakoff J, Piaggi P, Votruba S. Reduced Albumin Concentration Predicts Weight Gain and Higher Ad Libitum Energy Intake in Humans. Front Endocrinol (Lausanne). 2021 Mar 11;12:642568. doi: 10.3389/fendo.2021.642568. eCollection 2021.
PubMed 33776937Hollstein T, Basolo A, Ando T, Votruba SB, Krakoff J, Piaggi P. Urinary Norepinephrine Is a Metabolic Determinant of 24-Hour Energy Expenditure and Sleeping Metabolic Rate in Adult Humans. J Clin Endocrinol Metab. 2020 Apr 1;105(4):1145-56. doi: 10.1210/clinem/dgaa047.
PubMed 32002540Stinson EJ, Graham AL, Thearle MS, Gluck ME, Krakoff J, Piaggi P. Cognitive dietary restraint, disinhibition, and hunger are associated with 24-h energy expenditure. Int J Obes (Lond). 2019 Jul;43(7):1456-1465. doi: 10.1038/s41366-018-0305-9. Epub 2019 Jan 16.
PubMed 30651576Stinson EJ, Votruba SB, Venti C, Perez M, Krakoff J, Gluck ME. Food Insecurity is Associated with Maladaptive Eating Behaviors and Objectively Measured Overeating. Obesity (Silver Spring). 2018 Dec;26(12):1841-1848. doi: 10.1002/oby.22305. Epub 2018 Nov 14.
PubMed 30426695Basolo A, Heinitz S, Stinson EJ, Begaye B, Hohenadel M, Piaggi P, Krakoff J, Votruba SB. Fasting glucagon-like peptide 1 concentration is associated with lower carbohydrate intake and increases with overeating. J Endocrinol Invest. 2019 May;42(5):557-566. doi: 10.1007/s40618-018-0954-5. Epub 2018 Oct 3.
PubMed 30284224Stinson EJ, Piaggi P, Ibrahim M, Venti C, Krakoff J, Votruba SB. High Fat and Sugar Consumption During Ad Libitum Intake Predicts Weight Gain. Obesity (Silver Spring). 2018 Apr;26(4):689-695. doi: 10.1002/oby.22124. Epub 2018 Mar 4.
PubMed 29504262Stinson EJ, Krakoff J, Gluck ME. Depressive symptoms and poorer performance on the Stroop Task are associated with weight gain. Physiol Behav. 2018 Mar 15;186:25-30. doi: 10.1016/j.physbeh.2018.01.005. Epub 2018 Jan 9.
PubMed 29326031Basolo A, Votruba SB, Heinitz S, Krakoff J, Piaggi P. Deviations in energy sensing predict long-term weight change in overweight Native Americans. Metabolism. 2018 May;82:65-71. doi: 10.1016/j.metabol.2017.12.013. Epub 2018 Jan 3.
PubMed 29305947Ibrahim M, Thearle MS, Krakoff J, Gluck ME. Perceived stress and anhedonia predict short-and long-term weight change, respectively, in healthy adults. Eat Behav. 2016 Apr;21:214-9. doi: 10.1016/j.eatbeh.2016.03.009. Epub 2016 Mar 3.
PubMed 27002703Piaggi P, Thearle MS, Krakoff J, Votruba SB. Higher Daily Energy Expenditure and Respiratory Quotient, Rather Than Fat-Free Mass, Independently Determine Greater ad Libitum Overeating. J Clin Endocrinol Metab. 2015 Aug;100(8):3011-20. doi: 10.1210/jc.2015-2164. Epub 2015 Jun 18.
PubMed 26086330Bundrick SC, Thearle MS, Venti CA, Krakoff J, Votruba SB. Soda consumption during ad libitum food intake predicts weight change. J Acad Nutr Diet. 2014 Mar;114(3):444-449. doi: 10.1016/j.jand.2013.09.016. Epub 2013 Dec 8.
PubMed 24321742
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Food Intake Phenotype: Assessing Eating Behavior and Food Preferences as Risk Factors for Obesity
- ClinicalTrials.gov ID
- NCT00342732
- Acronym / sponsor ID
- 999999019
- Conditions
- Obesity, Overweight, Overnutrition
- Keywords
- Genetics, Fat Intake, Weight Control, Appetite Control, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 24 Nov 1999 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
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. 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-diabetic volunteers | – | –non-diabetic volunteers aged 18-65 who are healthy as determined by medical history, physical examination, and laboratory tests |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Phoenix metropolitan area
Key inclusion criteria (3 listed)
Key exclusion criteria (10 listed)
- 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, or heroin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ad libitum food intake
Time frame: Baseline, up to day 3
Ad libitum food intake measured in kcal/day averaged over 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 37833567Aydin BN, Stinson EJ, Cabeza De Baca T, Ando T, Travis KT, Piaggi P, Krakoff J, Chang DC. Investigation of seasonality of human spontaneous physical activity and energy expenditure in respiratory chamber in Phoenix, Arizona. Eur J Clin Nutr. 2024 Jan;78(1):27-33. doi: 10.1038/s41430-023-01347-y. Epub 2023 Oct 13.
- Derived from this study: PubMed 35674698Booker JM, Chang DC, Stinson EJ, Mitchell CM, Votruba SB, Krakoff J, Gluck ME, Cabeza de Baca T. Food insecurity is associated with higher respiratory quotient and lower glucagon-like peptide 1. Obesity (Silver Spring). 2022 Jun;30(6):1248-1256. doi: 10.1002/oby.23437.
- Derived from this study: PubMed 35074459Cabeza de Baca T, Piaggi P, Gluck ME, Krakoff J, Votruba SB. Meal-to-meal and day-to-day macronutrient variation in an ad libitum vending food paradigm. Appetite. 2022 Apr 1;171:105944. doi: 10.1016/j.appet.2022.105944. Epub 2022 Jan 21.
- Derived from this study: PubMed 34159373Basolo A, Hollstein T, Shah MH, Walter M, Krakoff J, Votruba SB, Piaggi P. Higher fasting plasma FGF21 concentration is associated with lower ad libitum soda consumption in humans. Am J Clin Nutr. 2021 Oct 4;114(4):1518-1522. doi: 10.1093/ajcn/nqab204.
- Derived from this study: PubMed 33776937Basolo A, Ando T, Chang DC, Hollstein T, Krakoff J, Piaggi P, Votruba S. Reduced Albumin Concentration Predicts Weight Gain and Higher Ad Libitum Energy Intake in Humans. Front Endocrinol (Lausanne). 2021 Mar 11;12:642568. doi: 10.3389/fendo.2021.642568. eCollection 2021.
- Derived from this study: PubMed 32002540Hollstein T, Basolo A, Ando T, Votruba SB, Krakoff J, Piaggi P. Urinary Norepinephrine Is a Metabolic Determinant of 24-Hour Energy Expenditure and Sleeping Metabolic Rate in Adult Humans. J Clin Endocrinol Metab. 2020 Apr 1;105(4):1145-56. doi: 10.1210/clinem/dgaa047.
- Derived from this study: PubMed 30651576Stinson EJ, Graham AL, Thearle MS, Gluck ME, Krakoff J, Piaggi P. Cognitive dietary restraint, disinhibition, and hunger are associated with 24-h energy expenditure. Int J Obes (Lond). 2019 Jul;43(7):1456-1465. doi: 10.1038/s41366-018-0305-9. Epub 2019 Jan 16.
- Derived from this study: PubMed 30426695Stinson EJ, Votruba SB, Venti C, Perez M, Krakoff J, Gluck ME. Food Insecurity is Associated with Maladaptive Eating Behaviors and Objectively Measured Overeating. Obesity (Silver Spring). 2018 Dec;26(12):1841-1848. doi: 10.1002/oby.22305. Epub 2018 Nov 14.
- Derived from this study: PubMed 30284224Basolo A, Heinitz S, Stinson EJ, Begaye B, Hohenadel M, Piaggi P, Krakoff J, Votruba SB. Fasting glucagon-like peptide 1 concentration is associated with lower carbohydrate intake and increases with overeating. J Endocrinol Invest. 2019 May;42(5):557-566. doi: 10.1007/s40618-018-0954-5. Epub 2018 Oct 3.
- Derived from this study: PubMed 29504262Stinson EJ, Piaggi P, Ibrahim M, Venti C, Krakoff J, Votruba SB. High Fat and Sugar Consumption During Ad Libitum Intake Predicts Weight Gain. Obesity (Silver Spring). 2018 Apr;26(4):689-695. doi: 10.1002/oby.22124. Epub 2018 Mar 4.
- Derived from this study: PubMed 29326031Stinson EJ, Krakoff J, Gluck ME. Depressive symptoms and poorer performance on the Stroop Task are associated with weight gain. Physiol Behav. 2018 Mar 15;186:25-30. doi: 10.1016/j.physbeh.2018.01.005. Epub 2018 Jan 9.
- Derived from this study: PubMed 29305947Basolo A, Votruba SB, Heinitz S, Krakoff J, Piaggi P. Deviations in energy sensing predict long-term weight change in overweight Native Americans. Metabolism. 2018 May;82:65-71. doi: 10.1016/j.metabol.2017.12.013. Epub 2018 Jan 3.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne M Votruba, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ad libitum food intake (time frame: Baseline, up to day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342732, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.