Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation (NCT06169137) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Study of Isocaloric Time Restricted Eating on Ketone Metabolism and Immunoregulation
United States150 participantsStarted 2024-09-04
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion 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
✕. 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)
What they're measuring
1
Change in ketone body (beta hydroxybutyrate) rate of appearance (Ra)
Timeframe: Day 0, Day 3
2
Change in CD4+ T cell responsiveness (Th17 polarization)
Timeframe: Day 0, Day 3
Trial details
NCT IDNCT06169137
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
✕. 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