Sleep Disorders Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Adult males between 18 and 65 years old, or pre-menopausal adult females between 18 and 50 years old — including those with a specific inherited form of diabetes called MODY2
- People whose weight has been stable (not changing by more than 5%) over the past 6 months
- People with a body mass index (BMI) of 25 or above (or 18.5 or above for those with MODY2) — BMI is a measure based on height and weight
- People who are physically able to ride a stationary bike at a moderate pace, staying within a specific heart rate range and without showing signs of irregular heartbeat (confirm with trial site for the exact target heart rate calculation)
Who may not be able to join:
- People currently taking prescription medications, other drugs, or supplements that may affect how the body uses energy or digests and absorbs nutrients — including weight-loss medications (confirm with trial site for full list)
- People with signs of liver disease, specifically having both a low albumin level and a high bilirubin level in their blood
- People with serious ongoing health conditions — for example, diabetes other than MODY2, moderate-to-severe heart failure, moderate or advanced kidney disease, or other significant medical conditions as assessed by the study team
- People without MODY2 who are taking prescription medication to treat high blood pressure
- People who already do more than 2 hours per week of vigorous exercise regularly
- People who are currently pregnant (applies to those who are able to become pregnant)
- Males with a low red blood cell percentage (haematocrit below 40%)
- Females with a low red blood cell percentage (haematocrit below 37%)
- People who consume more than 300 mg of caffeine per day
- Men who drink more than 3 alcoholic drinks per day, or women who drink more than 2 alcoholic drinks per day
- People who have regularly smoked, chewed tobacco, used e-cigarettes or vapes, used nicotine patches, or used illicit drugs in the past 6 months — a urine drug test may also be used
- People with psychological conditions such as eating disorders, depression, or bipolar disorder that the investigators consider incompatible with safe participation in the study
- People with strict dietary requirements (such as vegetarian, kosher, or food allergies) or a strong dislike of a large number of the foods used in the study
- People who are unwilling or unable to follow all study procedures — such as cycling tasks or activities of daily living — or who are not available for the full duration of the study
- People who are unwilling or unable to follow specific lifestyle guidelines required throughout the study
- People who are unwilling or unable to give informed consent
- People whose measured resting energy use (the calories the body burns at rest) differs by more than 30% from what would be predicted for someone of their age, sex, height, and weight
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Stephanie T Chung, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (301) 827-3324
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Mean change in sleeping energy expenditure between the ketogenic diet and the baseline run-in diet; Mean difference in sleeping energy expenditure between NR and placebo during the ketogenic diet
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.