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

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.

Conditions

Obesity, Body Weight

Study Overview

Study Details

Study overview

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.

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

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Bethesda

National Institutes of Health Clinical Center, Bethesda, Maryland, United States, 20892

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2027-02-05