Status:
RECRUITING
Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Body Weight
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 ...
Detailed Description
Study Description: Intermittent fasting confers anti-inflammatory effects, although underlying metabolic mechanisms are poorly defined. This pilot study will explore ketone bodies as a mediator of in...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
September 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 5 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06169137
Start Date
September 4 2024
End Date
February 5 2027
Last Update
August 22 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892