4-week nightly ketogenic supplement to improve nighttime metabolism and muscle health
The Effects of a 4-week Supplementation With a Ketogenic Nutrient Mix on 24-hour Substrate Metabolism and Muscle Health
We will test whether taking a ketogenic nutritional supplement each evening for 4 weeks helps older adults who are overweight improve their daily energy metabolism patterns and muscle health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht) |
| Trial ID | NCT07395973 on ClinicalTrials.gov |
What this trial studies
Healthy adults aged 60–80 with a BMI of 25–35 and low physical activity will take a daily evening ketogenic nutritional supplement or a non-ketogenic isocaloric control for four weeks. The intervention aims to induce a mild ketogenic state overnight and compare 24-hour rhythmicity in substrate metabolism between the two groups. Investigators will monitor metabolic patterns across the day and measure indicators of muscle health before and after the intervention. The study targets sedentary participants with stable weight and regular sleep schedules to limit confounding factors.
Who should consider this trial
Good fit: Healthy, sedentary adults aged 60–80 with BMI 25–35 kg/m2, stable body weight, regular sleep (7–9 hours), and no major organ failure or diabetes are ideal candidates.
Not a fit: People with type 2 diabetes, active congestive heart failure, severe renal or liver insufficiency, uncontrolled hypertension, high alcohol use, those on intermittent fasting, or with unstable weight are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could improve nighttime fat metabolism and help preserve or improve muscle health in older adults with overweight, potentially supporting metabolic health and physical function.
How similar studies have performed: Ketogenic diets and some ketogenic supplements have shown short-term metabolic and muscle effects in other studies, but prolonged nighttime ketogenic supplementation in older, overweight adults is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 60-80 years * Body mass index (BMI) 25-35 kg/m2 * Sedentary lifestyle (not more than 2 hours of structured physical activity per week in the past 3 months) * Stable dietary habits (no weight loss or gain \> 5 kg in the past 3 months) * Healthy (as determined by dependent physician based on medical questionnaire) * Regular sleeping habits (7-9h of daily sleep) Exclusion Criteria: * Type 2 diabetes * Participants with active congestive heart failure and/or severe renal and or liver insufficiency * Uncontrolled hypertension * Alcohol consumption of \>3 servings per day for men and \>2 servings per day for women * Unstable body weight (weight gain or loss \> 5 kg in the last 3 months) or intention to lose weight * Participants who are on an intermittent fasting diet * Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the investigator which would possibly hamper our study results * Significant food allergies/intolerance (seriously hampering study meals or study product) * Participants who do not want to be informed about unexpected medical findings * Blood donation during or within 2 months prior to the study * Disturbances in circadian rhythm determined with the follow criteria: * Extreme early bird or extreme night person (score ≤30 or ≥70 on MEQ-SA questionnaire) * Heavily varying sleep-wake rhythm * Night shift work during last 3 months * Travel across \> 1 time zone in the last 3 months * High daily caffeine intake \> 400mg (more than 4 cups of coffee or energy drinks)
Where this trial is running
Maastricht
- Maastricht University — Maastricht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Joris Hoeks, Dr. — Maastricht University
- Study coordinator: Merel Timmermans, MSc
- Email: merel.timmermans@maastrichtuniversity.nl
- Phone: 0031 88 3887793
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.