Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00523627
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2007-08-30
Brief Title:
Effects of Diet Changes on Metabolism
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Study of Short-Term Metabolic Adaptation Prediction of Weight Change and Effects of Macronutrient Manipulations
Status:
COMPLETED
Status Verified Date:
2024-06-28
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 IV 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
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 IV 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
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 Fifteen volunteers will have two additional chambers to try and understand if the source of carbohydrates ie simple sugars versus complex carbohydrates in a high carbohydrate diet affect metabolism Thirty volunteers are planned to also undergo 2 positron emission tomography PET studies to look at the relationship of brown fat with EE in adult humans As of April 2021 we will stop performing the PET scans 24 volunteers have completed them and we have acquired sufficient data 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-DK-N215 | None | None | None |