Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Diet Changes on Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00523627
Recruitment Status : Recruiting
First Posted : August 31, 2007
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Brief Summary:

This study, conducted at the NIH Clinical Research Unit at the Phoenix Indian Medical Center, will examine how the body s metabolism (energy expenditure) changes when people overeat and when they fast and how different diets (e.g., high-protein or high-fat) affect metabolism. The results may provide information about whether there are mechanisms that make some people more resistant than others to gaining weight when they eat more.

Non-smoking healthy subjects between 18 and 55 years of age who weigh no more than 350 pounds may be eligible for this study. Participants undergo the following procedures:

  • Pregnancy test for women of childbearing age.
  • Oral glucose tolerance test. For this test, an I.V. line (needle attached to a plastic tube) is inserted into a vein to allow several blood draws without repeated needle sticks. After the first blood sample is drawn, the subject drinks a cola-flavored sugar solution. Five additional blood samples are then drawn over 3 hours.
  • Blood test for DNA (genetic) studies related to obesity, diabetes and related medical problems.
  • DEXA scan. This test measures body fat. The subject lies on a table while a very small dose of X-rays is passed through the body.
  • Respiratory chamber. This test measures how many calories the body burns a day and assesses energy balance between intake and expenditure. Subjects stay in a room with two windows, equipped with a sink, toilet, television and DVD player, desk, chair, telephone and bed for 24 hours. The test is repeated five times during the first 18-day admission and 3 times during the second 13-day admission. For the first two sessions, subjects are fed a diet equal to the amount of energy their body uses. For the next 6 stays they are fed double the amount of calories their body usually uses for 5 of the stays and fast (consume nothing but water and soda without caffeine or calories) during 1 stay. The overfeeding diets may be high or low in protein, normal in protein, or high in fat. Blood tests are done on the day of each respiratory chamber session and a 24-hour urine sample is collected for one day while in the chamber.
  • Eating behavior questionnaires.
  • Psychological performance tests.

Some participants are asked to volunteer to repeat two of the chamber studies to validate the measurements. The repeat session includes only the fasting and the overfeeding with normal protein content.

All participants are followed at 6 months with blood tests, a DEXA scan, and urine tests (including pregnancy test for women). At annual visits for years 1 through 7, participants have the 6-month tests plus an oral glucose tolerance test.


Condition or disease
Obesity

Detailed Description:
Some people appear to be more resistant than others to gaining weight when they overeat, though they do not increase their physical activity. This may indicate that adaptive mechanisms exist, which lead to wasting as heat part of the excess calories taken in. Such mechanisms exist in rodents including activation of brown fat, a tissue which can also convert calories to heat for warmth. Human studies have provided conflicting results. A pilot study on the relationship of the weight change over time with the changes in the amount of energy an individual uses over 24 hours (energy expenditure, EE) with 48-h overfeeding (OF) and fasting (F) in Pima Indian men has shown that persons with the greatest increase in EE with OF and the smallest decrease in EE with F gained the least weight over time, indicating that the ability to waste more calories when overfed may reduce weight gain. Other studies, however, have not shown this relationship. In addition, it has been proposed that unbalanced diets can help magnify these effects. The aims of this study are to test whether (a) the changes in EE in response to 24-h OF and F predict changes in weight over two years, and (b) high-carbohydrate diets or diets with high or low protein amounts may magnify the metabolic response to 24-h OF compared to normal protein and high-fat diets. 64 volunteers will be evaluated at baseline, 6 months and on a yearly basis for up to 7 years. At baseline, subjects will undergo 8 24-h sessions in a human respiratory chamber to measure EE while on a weight-maintaining diet, and then in random order: fasting, 200% OF on a normal-protein diet, 200% OF on a high fat, low-protein diet, 200% OF on a high-fat, normal-protein diet, 200% OF on a high fat, high protein diet, and 200% OF on a high-carbohydrate, normal-protein diet. Twenty volunteers will have two additional chambers to try to understand what influences how a person responds to overeating. Fifteen volunteers will have two additional chambers to try and understand if the source of carbohydrates, i.e. simple sugars versus complex carbohydrates, in a high carbohydrate diet affect metabolism. Thirty volunteers will also undergo 2 positron emission tomography (PET) studies to look at the relationship of brown fat with EE in adult humans. Body weight and composition will be measured at each subsequent admission. Hormonal measurements to find determinants of adaptive changes in EE in response to OF and F will also be performed. This study will provide significant insights into possible mechanisms that may help people resist weight gain and obesity.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Short-Term Metabolic Adaptation: Prediction of Weight Change and Effects of Macronutrient Manipulations
Actual Study Start Date : May 22, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Group/Cohort
Healthy Volunteers with normal glucose regulation
Healthy volunteers with normal glucose regulation



Primary Outcome Measures :
  1. Weight, DXA scans [ Time Frame: at baseline visit, 6 month visit, and then annually for up to 7 years ]
    Changes in body weight and composition in response to overfeeding and fasting diets with high, normal, or low levels of carbohydrates,protein, or fat

  2. Resting metabolic rate, thermic effect of food, energy cost of physical activity, cycle ergometry, core body and distal skin temperature [ Time Frame: at baseline visit, 6 month visit, and then annually for up to 7 years ]
    Changes in energy expenditure in response to overfeeding and fasting diets with high, normal, or low levels of carbohydrates, protein, or fat

  3. Weight, DXA scans, resting metabolic rate, thermic effect of food, energy cost of physical activity, cycle ergometry, core body and distal skin temperature [ Time Frame: at baseline visit, 6 month visit, and then annually for up to 7 years ]
    Changes in body weight and composition in response to changes in energy expenditure


Secondary Outcome Measures :
  1. Resting metabolic rate, thermic effect of food, energy cost of physical activity, cycle ergometry, core body and distal skin temperature [ Time Frame: at baseline visit, 6 month visit, and then annually for up to 7 years ]
    Repeatability of changes in energy expenditure in response to overfeeding and fasting diets with high, normal, or low levels of carbohydrates, protein, or fat

  2. Hormone values in blood and urine [ Time Frame: at baseline visit, 6 month visit, and then annually for up to 7 years ]
    Changes in hormones involved in the regulation of energy metabolism in response to overfeeding and fasting diets with high, normal, or low levels of carbohydrates, protein, or fat

  3. Resting metabolic rate, thermic effect of food, energy cost of physical activity, cycle ergometry, FDG-PET and FDG- CT scans, core body and distal skin temperature [ Time Frame: at baseline visit, 6 month visit, and then annually for up to 7 years ]
    Changes in BAT levels in response to cool temperature (16 degrees C), changes in energy expenditure, or changes in diet

  4. Resting metabolic rate, thermic effect of food, energy cost of physical activity, cycle ergometry, core body and distal skin temperature [ Time Frame: at baseline visit, 6 month visit, and then annually for up to 7 years ]
    Changes in energy expenditure response to overfeeding in response to thermal insulation of the body core

  5. Core body and distal skin temperature [ Time Frame: at baseline visit, 6 month visit, and then annually for up to 7 years ]
    Changes in thermic effect of food during overfeeding in response to beta blockade

  6. Resting metabolic rate, thermic effect of food, energy cost of physical activity, cycle ergometry, core body and distal skin temperature [ Time Frame: at baseline visit, 6 month visit, and then annually for up to 7 years ]
    Effect of simple sugars and complex carbohydrates during overfeeding on energy expenditure

  7. Resting metabolic rate, thermic effect of food, energy cost of physical activity, cycle ergometry, core body and distal skin temperature, questionnaires [ Time Frame: at baseline visit, 6 month visit, and then annually for up to 7 years ]
    Predictive value of substrate oxidation in chambers for changes in appetite sensations upon completion of 24 hour respiratory chamber



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Residents of the Phoenix metropolitan area
Criteria
  • Inclusion Criteria:
  • Age: 18-55 years, to exclude effects of aging on energy expenditure and weight change. For the PET-CT substudy, women will be limited to ages 18-40 years because there is a high likelihood that for women greater than 40 years, their personal physician may recommend an annual routine mammogram, thereby increasing their annual radiation exposure. Men will also be limited to this age range to prevent age discrepancies between men and women for this substudy.
  • Premenopausal
  • Weight: less than or equal to 450 lb (maximum weight allowed on the DXA scanning tables by the manufacturer).
  • Only men with a percent body fat less than 25% and women with a percent body fat less than 33% will be eligible for the thermic effect of food (TEF) substudy as this substudy is designed to assess the effect of body core insulation in lean individuals.

Exclusion Criteria

  • History or clinical manifestation of:
  • Current smoking
  • Impaired glucose tolerance (IGT), type 1 and type 2 diabetes
  • Endocrine disorders, such as Cushing s disease, pituitary disorders, and hypo- and hyperthyroidism
  • Pulmonary disorders, including chronic obstructive pulmonary disease, which would limit ability to follow the protocol (investigator judgment)
  • Cardiovascular diseases, including coronary heart disease, heart failure, arrhythmias, and peripheral artery disease
  • Hypertension, as diagnosed and treated by an outside physician or by sitting blood pressure measurement, using an appropriate cuff, higher than 140/90 mmHg on two or more occasions
  • Liver disease, including cirrhosis, active hepatitis B or C, and AST or ALT greater than or equal to 3 times normal
  • Renal disease, as defined by serum creatinine concentrations greater than or equal 1.5 mg/dl and/or proteinuria greater than 300 mg/day (200 (Micro)g/min)
  • 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 (e.g., Stage 1 cervical cancer).
  • Infectious disease such as active tuberculosis, HIV (by self-report), chronic coccidiomycoses or other chronic infections that might influence weight.
  • Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators
  • Alcohol and/or drug abuse (more than 3 drinks per day and use of drugs, such as amphetamines, cocaine, heroin, or marijuana).
  • Pregnancy or lactation
  • For the PET-CT substudy, radiation exposure to the torso for research or medical purposes within the past 12 months
  • For the TEF substudy, an allergy to propranolol, a BP less than 100/60, or a contraindication to propranolol ingestion including asthma or bradycardia.

Prior to beginning any of the study procedures, all subjects will be fully informed of the aim, nature, and risks of the study prior to giving written informed consent. The study s informed consent will be obtained by a principal or associate investigator, research physician or physician assistant working in the clinical research unit.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523627


Contacts
Layout table for location contacts
Contact: Kateri Ware (602) 200-5300 wareka@mail.nih.gov
Contact: Jonathan Krakoff, M.D. (602) 200-5217 jkrakoff@mail.nih.gov

Locations
Layout table for location information
United States, Arizona
NIDDK, Phoenix Recruiting
Phoenix, Arizona, United States, 85014
Contact: Marie Thearle, M.D.    602-200-5304    thearlem@mail.nih.gov   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Jonathan Krakoff, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00523627     History of Changes
Other Study ID Numbers: 999907215
07-DK-N215
First Posted: August 31, 2007    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 4, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Energy Expenditure
Adaptive Thermogenesis
Low-protein Overfeeding
Fasting
Weight Gain