Energy Metabolism and Nutrient Absorption in Lean and Obese Individuals

NCT00414063 | Completed

• 2 other identifiers: 99990704807-DK-N048
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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. ...

Conditions

Obesity

Keywords

Fecal Energy; Urine Energy; Bomb Calorimetry; Gut Maintenance Flora; Obesity; Energy Metabolism

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

Location

Related Publications (5)

• Segal KR, Dunaif A. Resting metabolic rate and postprandial thermogenesis in polycystic ovarian syndrome. Int J Obes. 1990 Jul;14(7):559-67.

  PMID: 2228390 BACKGROUND

• 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.

  PMID: 1330961 BACKGROUND

• 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.

  PMID: 8288057 BACKGROUND

• 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.

  PMID: 33029899 DERIVED

• 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.

  PMID: 21543530 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Krakoff, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 20, 2006
• First Posted: December 21, 2006
• Study Start: December 15, 2006
• Study Completion: March 19, 2013
• Last Updated: December 17, 2019

Record last verified: 2013-03-19

Locations

US (1)