RECRUITING

Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation

Conditions

Obesity Body Weight Diet Time Restricted Eating Inflammation Ketone Bodies

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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: Time restricted eating (TRE) is a form of fasting in which a person eats only during a set window of time, which is usually between 4 and 10 hours each day. Researchers want to know more about how TRE may affect health. Objective: To learn how TRE affects women with different body sizes. Eligibility: Healthy women aged 18 to 50 years. Design: Participants will have 2 visits: 1 screening visit and one 5-day stay in the clinic. Participants will fast before both visits. They will have a physical exam with blood tests. They will talk to a nutritionist about the foods they eat. They will lay under a clear hood for up to 45 minutes during a test that measures how many calories they burn while resting. Participants will keep a food diary for up to 7 days before their clinic stay. They will apply a continuous glucose monitor the day before they go to the clinic. This is a device that attaches to the skin of the stomach. They will wear this device throughout their clinic stay. All meals will be provided during the clinic stay. Participants will follow TRE on 3 days. They will answer survey questions and have tests during their stay, including: * DXA (dual energy X-ray absorptiometry) scan. Participants will lie on a padded table. Their body will be scanned to measure how much muscle, bone, fat, and other tissues they have. * Stable isotope tracer study. Small amounts of sugar and other substances will be given through a tube attached to a needle inserted into a vein in the arm. Blood samples will be collected.

Official Title

Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation

Quick Facts

Study Start:2024-09-04

Study Completion:2027-02-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06169137

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:FEMALE

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. Women between ages 18-50 years who are premenopausal (defined as regular menses and/or FSH \<ULN) 3. BMI of 18-24.9 or \>=30 kg/m\^2 4. In good general health as evidenced by medical history and/or screening laboratory evaluation. 5. Agreement to adhere to Lifestyle Considerations throughout study duration	1. Diagnosis/treatment for immune/inflammatory disorder or other metabolic conditions that would interfere with study parameters, including diabetes, chronic kidney, chronic liver disease, history of hypoglycemia, and thyroid disease (with the exception of chronic controlled hypothyroidism as measured by TSH within normal limits) 2. Current use of antihyperglycemic medications, systemic steroids, adrenergic-stimulating agents, or medications affecting sleep, circadian rhythms, or metabolism which affect parameters under investigation (examples include oral contraceptives, anti-diabetic agents, nicotinamide riboside, tryptophan, vitamin B3 supplements) 3. Caffeine consumption in excess of approximately 300 mg (approximately three 8-oz cups of coffee) daily 4. Factors that affect circadian rhythms including individuals who perform overnight shift work, report irregular sleep and/or eating schedules, and who regularly fast for more than 15 hours/day 5. History of an eating disorder by self-report or medical history 6. Food allergies/intolerances or dietary patterns that would prohibit consumption of metabolic diet 7. Inability to provide informed consent 8. Pregnancy or lactation 9. Unstable weight with more than 5% body weight change in last previous 3 months 10. Engaged in competitive sports training and/ or unwilling to comply with exercise regimen in this protocol. 11. Consumption of more than 3 servings of alcohol daily 12. Current smoker or regular tobacco use, vaping, or other forms of nicotine within prior 3 months

Inclusion Criteria

Exclusion Criteria

1. Stated willingness to comply with all study procedures and availability for the duration of the study
2. Women between ages 18-50 years who are premenopausal (defined as regular menses and/or FSH \<ULN)
3. BMI of 18-24.9 or \>=30 kg/m\^2
4. In good general health as evidenced by medical history and/or screening laboratory evaluation.
5. Agreement to adhere to Lifestyle Considerations throughout study duration

1. Diagnosis/treatment for immune/inflammatory disorder or other metabolic conditions that would interfere with study parameters, including diabetes, chronic kidney, chronic liver disease, history of hypoglycemia, and thyroid disease (with the exception of chronic controlled hypothyroidism as measured by TSH within normal limits)
2. Current use of antihyperglycemic medications, systemic steroids, adrenergic-stimulating agents, or medications affecting sleep, circadian rhythms, or metabolism which affect parameters under investigation (examples include oral contraceptives, anti-diabetic agents, nicotinamide riboside, tryptophan, vitamin B3 supplements)
3. Caffeine consumption in excess of approximately 300 mg (approximately three 8-oz cups of coffee) daily
4. Factors that affect circadian rhythms including individuals who perform overnight shift work, report irregular sleep and/or eating schedules, and who regularly fast for more than 15 hours/day
5. History of an eating disorder by self-report or medical history
6. Food allergies/intolerances or dietary patterns that would prohibit consumption of metabolic diet
7. Inability to provide informed consent
8. Pregnancy or lactation
9. Unstable weight with more than 5% body weight change in last previous 3 months
10. Engaged in competitive sports training and/ or unwilling to comply with exercise regimen in this protocol.
11. Consumption of more than 3 servings of alcohol daily
12. Current smoker or regular tobacco use, vaping, or other forms of nicotine within prior 3 months

Contacts and Locations

Study Contact

Lilian S Mabundo

CONTACT

(240) 383-9379

lilian.mabundo@nih.gov

Stephanie T Chung, M.D.

CONTACT

(240) 479-8137

stephanie.chung@nih.gov

Principal Investigator

Stephanie T Chung, M.D.

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)

Stephanie T Chung, M.D., 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 Date2024-09-04

Study Completion Date2027-02-05

Study Record Updates

Study Start Date2024-09-04

Study Completion Date2027-02-05

Terms related to this study

Keywords Provided by Researchers

Diet
Time Restricted Eating
Inflammation
Ketone Bodies

Additional Relevant MeSH Terms

Obesity
Body Weight