4-week nightly ketogenic supplement to improve nighttime metabolism and muscle health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.