RECRUITING

Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change

Conditions

Overweight Obesity Diet Body Fat Nutrition weight-loss

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change

Quick Facts

Study Start:2024-08-28

Study Completion:2026-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06325722

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Adults aged 18-50 years 3. Weight stable (\< +/- 5 percent over past 6 months) as determined by volunteer report 4. Body mass index (BMI) \>= 25 kg/m\^2 5. Agreement to adhere to Lifestyle Considerations throughout the study duration	1. Subjects with cardiac pacemakers or other implants that may be affected by or affect the DXA measurements 2. Inadequate access to equipment required for the study (e.g., too little refrigerator storage space or a microwave oven that is too small) as determined by discretion of PI and/or study team 3. Evidence of diseases or conditions that may influence appetite (e.g., cancer, diabetes, alterations of smell or taste post COVID-19), diseases or conditions that affect the immune system, or other conditions at the discretion of the PI and/or study team 4. Taking prescription medications or other drugs that may influence metabolism (including but not limited to diet/weight-loss medication, some psychiatric medications, or other medications at the discretion of the PI and/or study team) 5. People unlikely to adhere to a relatively consistent daily and weekly routine and avoid travel during their participation in the study. For example, people with occupations such as pilots, flight attendants, or frequently travel for work or pleasure. 6. Positive pregnancy test or lactating as determined by volunteer report (women only) 7. Inability or unwillingness to use birth control between screening and completion of the study (women only) 8. Symptoms or signs of perimenopause or menopause by volunteer report (women only) 9. Regular vigorous exercise \>150 min per week as determined by volunteer report 10. Alcohol consumption \> 3 drinks per day as determined by volunteer report 11. Regular use of tobacco (smoking, chewing, or vaping), nicotine replacement therapy, or illicit drugs over past 6 months as determined by volunteer report. Subjects may also be excluded based on a urine drug test. 12. Psychological conditions as determined by DSM-5 Self-rated Level 1 Cross-cutting Symptom Measure such as (but not limited to) eating disorders, depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators 13. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) or a reported dislike of a significant fraction of the study foods 14. Volunteers unwilling or unable to give informed consent 15. Non-English speakers due to unavailability of required questionnaires in other languages

Inclusion Criteria

Exclusion Criteria

1. Stated willingness to comply with all study procedures and availability for the duration of the study
2. Adults aged 18-50 years
3. Weight stable (\< +/- 5 percent over past 6 months) as determined by volunteer report
4. Body mass index (BMI) \>= 25 kg/m\^2
5. Agreement to adhere to Lifestyle Considerations throughout the study duration

1. Subjects with cardiac pacemakers or other implants that may be affected by or affect the DXA measurements
2. Inadequate access to equipment required for the study (e.g., too little refrigerator storage space or a microwave oven that is too small) as determined by discretion of PI and/or study team
3. Evidence of diseases or conditions that may influence appetite (e.g., cancer, diabetes, alterations of smell or taste post COVID-19), diseases or conditions that affect the immune system, or other conditions at the discretion of the PI and/or study team
4. Taking prescription medications or other drugs that may influence metabolism (including but not limited to diet/weight-loss medication, some psychiatric medications, or other medications at the discretion of the PI and/or study team)
5. People unlikely to adhere to a relatively consistent daily and weekly routine and avoid travel during their participation in the study. For example, people with occupations such as pilots, flight attendants, or frequently travel for work or pleasure.
6. Positive pregnancy test or lactating as determined by volunteer report (women only)
7. Inability or unwillingness to use birth control between screening and completion of the study (women only)
8. Symptoms or signs of perimenopause or menopause by volunteer report (women only)
9. Regular vigorous exercise \>150 min per week as determined by volunteer report
10. Alcohol consumption \> 3 drinks per day as determined by volunteer report
11. Regular use of tobacco (smoking, chewing, or vaping), nicotine replacement therapy, or illicit drugs over past 6 months as determined by volunteer report. Subjects may also be excluded based on a urine drug test.
12. Psychological conditions as determined by DSM-5 Self-rated Level 1 Cross-cutting Symptom Measure such as (but not limited to) eating disorders, depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators
13. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) or a reported dislike of a significant fraction of the study foods
14. Volunteers unwilling or unable to give informed consent
15. Non-English speakers due to unavailability of required questionnaires in other languages

Contacts and Locations

Study Contact

Nan Zhai, C.R.N.P.

CONTACT

(301) 827-3324

nan.zhai@nih.gov

Valerie L Darcey

CONTACT

(301) 402-9689

valerie.darcey@nih.gov

Principal Investigator

Valerie L Darcey

PRINCIPAL_INVESTIGATOR

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

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

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

Valerie L Darcey, PRINCIPAL_INVESTIGATOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-28

Study Completion Date2026-07-31

Study Record Updates

Study Start Date2024-08-28

Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

Diet
Body Fat
Nutrition
weight-loss

Additional Relevant MeSH Terms

Overweight
Obesity