ObesityNCT00414063
Energy Metabolism and Nutrient Absorption in Lean and Obese Individuals
An observational study of Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2006to 19 Mar 2013
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
...
Read the detailed description
The prevalence of obesity has risen to epidemic proportions in the world, resulting from both excessive energy intake and low levels of energy expenditure. The effect of nutrient absorption on energy balance, that is, the relative amount of nutrients consumed vs. the amount excreted in stool, has been reported only in small studies in which energy waste in feces and urine between lean and obese individuals was not found to be different. However, these studies were limited by small sample sizes and were not specifically designed to examine whether stool energy loss varied between lean and obese individuals. In addition, little is known about the reproducibility of the measurements of energy loss in stool and urine. We propose to investigate (i) whether there are significant differences in energy loss (as measured in stool and urine) between obese and lean individuals, and (ii) to examine the reproducibility of these measurements. Because the literature suggests a role for enteric bacterial flora in obesity, we will also examine differences in such flora between these groups. We plan to study 25 obese and 25 lean healthy non-smoking Caucasian men age 18 - 45 years old, not taking any medications (including medications for weight loss, antibiotics or probiotics) for the examination of differences in nutrient energy loss. Of these subjects, 10 lean and 10 obese individuals will be invited to repeat the study to test the reproducibility of these measurements. All participants will be admitted to the Clinical Research Unit for 15 days. During their stay, subjects will be fed a weight maintaining diet for 3 days, followed in a random cross-over design by two experimental diets: a 2400 kcal/d or 3400 kcal/d diet for 3 days. Twenty four-hour urine and feces collections will take place each day of the experimental diet period. The energy content of these waste products as well as that of the diet (using duplicate plate analysis) will be measured by bomb calorimetry. Bacterial components in feces will be extracted by repeated fractional centrifugation to obtain bacterial mass and by using 16S rDNA-based oligonucleotide probes to obtain bacterial flora. Primary results will examine the differences in energy loss between lean and obese individuals as well as the reproducibility of the measurements of stool and urine energy content.
- Conditions
- Obesity
- Keywords
- Fecal Energy, Urine Energy, Bomb Calorimetry, Gut Maintenance Flora, Obesity, Energy Metabolism
- Medical subject headings
- Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study start15 Dec 2006
- Study completion19 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Jonathan Krakoff, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414063
- Sponsor's protocol ID
- 999907048
- Other IDs
- 07-DK-N048
- Status last verified
- 19 Mar 2013
- First submitted
- 20 Dec 2006
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Segal KR, Dunaif A. Resting metabolic rate and postprandial thermogenesis in polycystic ovarian syndrome. Int J Obes. 1990 Jul;14(7):559-67.
PubMed 2228390Vansant 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.
PubMed 1330961Gougeon 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.
PubMed 8288057Basolo 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.
PubMed 33029899Jumpertz 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.
PubMed 21543530
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Differences in Energy Metabolism and Nutrient Absorption Between Lean and Obese Individuals
- ClinicalTrials.gov ID
- NCT00414063
- Acronym / sponsor ID
- 999907048
- Conditions
- Obesity
- Keywords
- Fecal Energy, Urine Energy, Bomb Calorimetry, Gut Maintenance Flora, Obesity, Energy Metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 15 Dec 2006
- Study completion
- 19 Mar 2013
- First posted
- 21 Dec 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.
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.
...
Detailed description
The prevalence of obesity has risen to epidemic proportions in the world, resulting from both excessive energy intake and low levels of energy expenditure. The effect of nutrient absorption on energy balance, that is, the relative amount of nutrients consumed vs. the amount excreted in stool, has been reported only in small studies in which energy waste in feces and urine between lean and obese individuals was not found to be different. However, these studies were limited by small sample sizes and were not specifically designed to examine whether stool energy loss varied between lean and obese individuals. In addition, little is known about the reproducibility of the measurements of energy loss in stool and urine. We propose to investigate (i) whether there are significant differences in energy loss (as measured in stool and urine) between obese and lean individuals, and (ii) to examine the reproducibility of these measurements. Because the literature suggests a role for enteric bacterial flora in obesity, we will also examine differences in such flora between these groups. We plan to study 25 obese and 25 lean healthy non-smoking Caucasian men age 18 - 45 years old, not taking any medications (including medications for weight loss, antibiotics or probiotics) for the examination of differences in nutrient energy loss. Of these subjects, 10 lean and 10 obese individuals will be invited to repeat the study to test the reproducibility of these measurements. All participants will be admitted to the Clinical Research Unit for 15 days. During their stay, subjects will be fed a weight maintaining diet for 3 days, followed in a random cross-over design by two experimental diets: a 2400 kcal/d or 3400 kcal/d diet for 3 days. Twenty four-hour urine and feces collections will take place each day of the experimental diet period. The energy content of these waste products as well as that of the diet (using duplicate plate analysis) will be measured by bomb calorimetry. Bacterial components in feces will be extracted by repeated fractional centrifugation to obtain bacterial mass and by using 16S rDNA-based oligonucleotide probes to obtain bacterial flora. Primary results will examine the differences in energy loss between lean and obese individuals as well as the reproducibility of the measurements of stool and urine energy content.
Study design
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (19 listed)
- History or clinical manifestation of:
- 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)
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
Not reported in the source record.
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 17 Dec 2019.
- Background: PubMed 2228390Segal KR, Dunaif A. Resting metabolic rate and postprandial thermogenesis in polycystic ovarian syndrome. Int J Obes. 1990 Jul;14(7):559-67.
- Background: PubMed 1330961Vansant 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.
- Background: PubMed 8288057Gougeon 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.
- Derived from this study: PubMed 33029899Basolo 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.
- Derived from this study: PubMed 21543530Jumpertz 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.
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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.
Jonathan Krakoff, M.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, 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 4 inclusion and 19 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 17 Dec 2019. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00414063, which also lists 5 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 17 Dec 2019.