Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation
2 other identifiers
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Sep 2024
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2023
CompletedFirst Posted
Study publicly available on registry
December 13, 2023
CompletedStudy Start
First participant enrolled
September 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 5, 2027
August 22, 2025
August 20, 2025
2.4 years
December 11, 2023
August 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in ketone body (beta hydroxybutyrate) rate of appearance (Ra)
Within subject difference in ketone body (beta hydroxybutyrate) rate of appearance (Ra) after 3 days of 6-hr TRE compared to a 12-hr eating window regimen
Day 0, Day 3
Change in CD4+ T cell responsiveness (Th17 polarization)
Within subject difference in CD4+ T cell response after 3 days of 6-hr TRE compared to a 12-hr eating window regimen
Day 0, Day 3
Secondary Outcomes (4)
Change in post-absorptive glucose rate of appearance (Ra)
Day 0, Day 3
Change in ketone body rate of appearance (Ra) in lean women vs women with obesity
Day 0, Day 3
Change in CD4+ T cell responsiveness (Th17 polarization) in lean women vs women with obesity
Day 0, Day 3
Ketone biology in isolated CD4+ T cells
Day 0, Day 3
Study Arms (1)
Premenopausal women (lean and obese)
EXPERIMENTALAges 18-50 yearsBMI 18.0-24.5 mg/k\^2 or BMI \> 30 mg/k\^2
Interventions
Participants will be provided all meals to consume within a 6-hour timeframe (9:30-3:30p)
Participants will be provided all meals to consume within a 12-hour timeframe (9:30a-9:30p)
Eligibility Criteria
You may qualify if:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Women between ages 18-50 years who are premenopausal (defined as regular menses and/or FSH \<ULN)
- BMI of 18-24.9 or \>=30 kg/m\^2
- In good general health as evidenced by medical history and/or screening laboratory evaluation.
- Agreement to adhere to Lifestyle Considerations throughout study duration
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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)
- 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)
- Caffeine consumption in excess of approximately 300 mg (approximately three 8-oz cups of coffee) daily
- 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
- History of an eating disorder by self-report or medical history
- Food allergies/intolerances or dietary patterns that would prohibit consumption of metabolic diet
- Inability to provide informed consent
- Pregnancy or lactation
- Unstable weight with more than 5% body weight change in last previous 3 months
- Engaged in competitive sports training and/ or unwilling to comply with exercise regimen in this protocol.
- Consumption of more than 3 servings of alcohol daily
- Current smoker or regular tobacco use, vaping, or other forms of nicotine within prior 3 months
- This study will recruit only women. The study design was informed by our Protocol NCT04728165 which investigates an identical 6:18h TRE intervention in males who are healthy and those with psoriasis. Based on our pilot data in men, the current study is needed to test our hypothesis in women. This study in women is a critical next step to replicate the findings in women and to understand sex-specific differences in TRE response and ketone metabolism.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (2)
Han K, Nguyen A, Traba J, Yao X, Kaler M, Huffstutler RD, Levine SJ, Sack MN. A Pilot Study To Investigate the Immune-Modulatory Effects of Fasting in Steroid-Naive Mild Asthmatics. J Immunol. 2018 Sep 1;201(5):1382-1388. doi: 10.4049/jimmunol.1800585. Epub 2018 Jul 18.
PMID: 30021766BACKGROUNDPuchalska P, Crawford PA. Metabolic and Signaling Roles of Ketone Bodies in Health and Disease. Annu Rev Nutr. 2021 Oct 11;41:49-77. doi: 10.1146/annurev-nutr-111120-111518.
PMID: 34633859BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie T Chung, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2023
First Posted
December 13, 2023
Study Start
September 4, 2024
Primary Completion (Estimated)
February 5, 2027
Study Completion (Estimated)
February 5, 2027
Last Updated
August 22, 2025
Record last verified: 2025-08-20
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- The data will be provided upon request within 1 year after publication and will be available to indefinitely
- Access Criteria
- The PI will accept requests from other researchers who are examining pertinent outcomes
The investigators will provide raw data (without identifying information) to journals or other researchers upon request.