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

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Dec 11, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a type of eating schedule called time-restricted eating (TRE) to see how it affects women’s health, particularly in relation to body weight and metabolism. TRE involves eating only during a specific time frame each day, usually between 4 to 10 hours. The researchers want to understand how this eating pattern impacts women of different body sizes, especially regarding their metabolism and immune system.

To participate, women aged 18 to 50 who are in good health and have a body mass index (BMI) in the normal range or are considered obese can apply. Participants will visit the clinic for two appointments, where they’ll receive a physical examination, have blood tests, and discuss their eating habits with a nutritionist. During a 5-day stay at the clinic, they will follow the TRE schedule, wear a device to monitor their glucose levels, and take part in various tests to assess their metabolism. All meals will be provided, and participants will also be asked to keep a food diary before their stay. This study is vital for understanding how TRE may work differently for women compared to men.

Gender

FEMALE

Eligibility 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.