- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00414063
Energy Metabolism and Nutrient Absorption in Lean and Obese Individuals
Investigation of Differences in Energy Metabolism and Nutrient Absorption Between Lean and Obese Individuals
This study will examine whether there are differences in energy (calories) losses in stool and urine between lean and obese people. People gain weight when the amount of calories in the food they eat is greater than the amount of calories their body uses to support its functions and activities. The balance between caloric intake and expenditure may be affected by the amount of calories from food that is not absorbed but is lost in stool and urine. This study will examine whether differences in food absorption are related to obesity.
Healthy normal volunteers between 18 and 45 years of age with a body mass index (BMI) of 18-25 kg/m2 or less than 35 kg/m2 may be eligible for this 15-day study. Participants are admitted to the Clinical Research Unit at the Phoenix Indian Medical Center for the study.
Participants undergo the following tests and procedures:
- Experimental diets with dye marker: Subjects are fed a 2400-calorie diet and a 3400-calorie diet for 3 days each. On the first of the day of each diet, a blue dye marker is added to the breakfast meal. A red marker is added to the breakfast meal of the first day after the diet period. Urine is collected beginning after breakfast on the first day of the diet and until before breakfast on the last day of the diet. Stool samples are collected during the entire diet period, and until the appearance of the red dye in the stool.
- 24-hour metabolic rate in the respiratory chamber: After the first diet period, subjects spend 24 hours in a respiratory chamber to measure the number of calories the body burns a day and to assess the energy balance between intake and expenditure.
- Stool sample: Stool samples are collected on days 1 and 2 of the study to look for parasites or internal bleeding that may affect nutrient absorption.
- DXA scanning: This scan uses a low dose of X-rays to measure body fat.
- Oral glucose tolerance test: For this test for diabetes, an I.V. line (needle attached to a small plastic tube) is inserted into an arm vein. The subject drinks a sugar solution. Small blood samples are drawn from the I.V. before the subject drinks the solution and at five intervals during the 3 (Omega)-hour test period.
- Fasting blood tests: On the first day of each diet and on the day after each diet is completed a blood sample is drawn before breakfast to measure hormones that may affect the ability to absorb food.
At the end of the study, some participants may be asked to repeat the experimental diets and stool and urine collections.
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Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85014
- NIDDK, Phoenix
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
- Free of acute and chronic diseases (especially GI disorders) as determined by medical history, physical examination and laboratory tests.
- Individuals may be taking antacids and/or laxative drugs but they must be discontinued 3 or more weeks before admission.
- Age 18-45 years (in order to minimize the effect of aging on nutrient absorption).
- BMI 18-25 kg/m(2) or greater than 35 kg/m(2).
EXCLUSION CRITERIA:
History or clinical manifestation of:
- Current smoking
- Type 2 diabetes (according to the World Health Organization diagnostic criteria)
- Endocrine disorders, such as Cushing's disease, pituitary disorders, and hypo- and hyperthyroidism
- HIV infection (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV
- Active tuberculosis (self-report)
- Pulmonary disorders, including physician diagnosed chronic obstructive pulmonary diseases and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study
- Cardiovascular diseases, including coronary heart disease, heart failure, arrhythmias, and peripheral artery disease
- Hypertension (according to the World Health Organization diagnostic criteria), treated or uncontrolled
- Gastrointestinal disease, including inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active)
- Lactose intolerance
- Liver disease, including non-alcoholic fatty liver disease, AST or ALT greater than 1.5 x normal value, cirrhosis, active hepatitis B or C
- Renal disease, as defined by serum creatinine concentrations greater than 1.5 mg/dl and/or overt proteinuria
- Central nervous system disease, including previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders
- Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or, in the opinion of the investigator, carry an excellent prognosis
- Behavioral or psychiatric conditions that would be incompatible with a safe and successful participation in the study (such as major depression, schizophrenia and presence of psychotic symptoms)
- Taking weight loss drugs
- Use of any antibiotic or probiotic agents within the 2 months prior to the study
- Evidence of alcohol and/or drug abuse (more than 3 drinks per day and use of drugs, such as amphetamines, cocaine, heroin, or marijuana)
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Basolo A, Parrington S, Ando T, Hollstein T, Piaggi P, Krakoff J. Procedures for Measuring Excreted and Ingested Calories to Assess Nutrient Absorption Using Bomb Calorimetry. Obesity (Silver Spring). 2020 Dec;28(12):2315-2322. doi: 10.1002/oby.22965. Epub 2020 Oct 7.
- Segal KR, Dunaif A. Resting metabolic rate and postprandial thermogenesis in polycystic ovarian syndrome. Int J Obes. 1990 Jul;14(7):559-67.
- Vansant G, Van Gaal L, De Leeuw I. Impact of obesity on resting metabolic rate and glucose-induced thermogenesis in non-insulin dependent diabetes mellitus. Int J Obes Relat Metab Disord. 1992 Oct;16(10):817-23.
- Gougeon R, Pencharz PB, Marliss EB. Effect of NIDDM on the kinetics of whole-body protein metabolism. Diabetes. 1994 Feb;43(2):318-28. doi: 10.2337/diab.43.2.318.
- Jumpertz R, Le DS, Turnbaugh PJ, Trinidad C, Bogardus C, Gordon JI, Krakoff J. Energy-balance studies reveal associations between gut microbes, caloric load, and nutrient absorption in humans. Am J Clin Nutr. 2011 Jul;94(1):58-65. doi: 10.3945/ajcn.110.010132. Epub 2011 May 4.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999907048
- 07-DK-N048
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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