Metabolic Flexibility and Ketone Production During Energy Deficit (NCT07429058) | Clinical Trial Compass
CompletedNot Applicable
Metabolic Flexibility and Ketone Production During Energy Deficit
Germany30 participantsStarted 2023-11-24
Plain-language summary
This randomized, interventional study examines the effects of short-term carbohydrate restriction, with and without caloric restriction, on indices of metabolic flexibility in healthy adults. Participants are randomly assigned to either a low-carbohydrate diet or a standard diet under energy balance, followed by the same diet under controlled caloric restriction. Primary outcomes include measures of carbon dioxide production, breath ketones and interstitial glucose. Secondary outcomes include blood and urinary ketones, body weight, body composition, and selected metabolic biomarkers.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-40 years
* Body mass index (BMI) 18.5-27 kg/m²
* Regular exercise or vigorous physical activity at least once per week
* Willing and able to comply with the dietary intervention and study procedures
* For female participants: non-pregnant and using hormonal contraception
Exclusion Criteria:
* Acute or chronic illness
* Metabolic disorders or conditions associated with altered glucose or lipid metabolism (exclusion of pre-diabetes and diabetes via HbA1c measurement)
* Use of medications known to interfere with study outcomes
* Intolerance or allergy to components of the study diets
* Pregnancy or breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Carbon dioxide production and breath acetone concentration
Timeframe: Baseline, during the energy-deficit intervention period, and post-intervention (over approximately 3 weeks)
2
Interstitial glucose concentration assessed by continuous glucose monitoring
Timeframe: Continuously assessed throughout the study period (approximately 3 weeks)