Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325722
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-03-21
Brief Title:
Diet Order Effects of Low Fat vs Low Carb Diets on Body Fat Change
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Diet Order Effects of Low Fat vs Low Carb Diets on Body Fat Change
Status:
RECRUITING
Status Verified Date:
2024-10-16
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:
Background
In a previous study participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home
Objective
To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks
Eligibility
Adults aged 19 to 50 years with a body mass index of 25 or more
Design
Participants will complete the study at their homes but there will be 3 required visits to the NIH Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn Before the diets begin participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out They will have scans to measure their bone density and how much muscle and body fat they have They will give stool blood and urine samples
Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks All meals will be delivered to the participants homes They will eat only the foods delivered
Participants will weigh themselves daily They will wear a monitor to track their physical activity and a sensor to measure their glucose levels They will prick their finger each morning to test a drop of blood for ketones Participants will meet virtually as a group with the study team weekly Participants will have two more NIH visits towards the end of each diet period
In a previous study participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home
Objective
To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks
Eligibility
Adults aged 19 to 50 years with a body mass index of 25 or more
Design
Participants will complete the study at their homes but there will be 3 required visits to the NIH Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn Before the diets begin participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out They will have scans to measure their bone density and how much muscle and body fat they have They will give stool blood and urine samples
Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks All meals will be delivered to the participants homes They will eat only the foods delivered
Participants will weigh themselves daily They will wear a monitor to track their physical activity and a sensor to measure their glucose levels They will prick their finger each morning to test a drop of blood for ketones Participants will meet virtually as a group with the study team weekly Participants will have two more NIH visits towards the end of each diet period
Detailed Description:
Study Description
This is an 8-week crossover outpatient feeding trial of a low carbohydrate versus a low-fat diet each provided for 4 weeks in random order with no washout period in adult volunteers with overweight or obesity
Objectives
Primary Objectives To determine the effect of diet order on the mean total fat mass change in subjects randomized to receive either a low carbohydrate followed by a low fat diet or the reverse order with each diet lasting for 4 weeks
Secondary Objectives To determine the effect of diet order on the mean rate of body weight change in subjects randomized to receive either a low carbohydrate followed by a low fat diet or the reverse order with each diet lasting for 4 weeks and the rate of weight change is measured during the last 2 weeks of each diet To determine the effect of diet order on mean total body weight change in subjects randomized to receive either a low carbohydrate followed by a low fat diet or the reverse order with each diet lasting for 4 weeks
Endpoints
Primary Endpoint Mean total fat mass change measured by dual energy X- ray absorptiometry at baseline and week 8
Secondary Endpoints Mean rate of weight change by linear mixed modeling of daily weight measurements Mean total body weight change measured between baseline and week 8
This is an 8-week crossover outpatient feeding trial of a low carbohydrate versus a low-fat diet each provided for 4 weeks in random order with no washout period in adult volunteers with overweight or obesity
Objectives
Primary Objectives To determine the effect of diet order on the mean total fat mass change in subjects randomized to receive either a low carbohydrate followed by a low fat diet or the reverse order with each diet lasting for 4 weeks
Secondary Objectives To determine the effect of diet order on the mean rate of body weight change in subjects randomized to receive either a low carbohydrate followed by a low fat diet or the reverse order with each diet lasting for 4 weeks and the rate of weight change is measured during the last 2 weeks of each diet To determine the effect of diet order on mean total body weight change in subjects randomized to receive either a low carbohydrate followed by a low fat diet or the reverse order with each diet lasting for 4 weeks
Endpoints
Primary Endpoint Mean total fat mass change measured by dual energy X- ray absorptiometry at baseline and week 8
Secondary Endpoints Mean rate of weight change by linear mixed modeling of daily weight measurements Mean total body weight change measured between baseline and week 8
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 |
|---|---|---|---|
| 001680-DK | None | None | None |