Exploring the effects of time-restricted eating on metabolism and immune response in women
Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation
This study is testing if eating within a 6-hour window can improve metabolism and immune response in women compared to a regular 12-hour eating schedule.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06169137 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates how time-restricted eating (TRE) impacts ketone metabolism and immune regulation in women of varying body sizes. Participants will engage in a 6-hour eating window followed by an 18-hour fasting period, compared to a conventional 12-hour eating regimen. The study includes physical exams, blood tests, and the use of continuous glucose monitors to assess metabolic responses. The primary aims focus on measuring ketone body turnover and CD4+ T cell responses after the dietary interventions.
Who should consider this trial
Good fit: Ideal candidates are healthy premenopausal women aged 18 to 50 with a BMI between 18-24.9 or 30 and above.
Not a fit: Patients with diagnosed immune or inflammatory disorders, metabolic conditions, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary strategies that improve metabolic health and reduce inflammation in women.
How similar studies have performed: While time-restricted eating has shown promise in other studies, this specific approach focusing on ketone metabolism and immune response is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following 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 EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 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 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie T Chung, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Lilian S Mabundo
- Email: lilian.mabundo@nih.gov
- Phone: (240) 383-9379
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.