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NCT07395973Recruiting

The Effects of a 4-week Supplementation With a Ketogenic Nutrient Mix on 24-hour Substrate Metabolism and Muscle Health

Source: ClinicalTrials.gov · Last updated 9 Feb 2026

Brief summary (registry, in English)

This study will investigate the effect of providing a daily ketogenic nutritional supplement in the evening for a prolonged time (4 weeks) to induce a mild ketogenic state during the night in healthy elderly (60-80 years), overweight/obese (BMI: 25-35 kg/m2) individuals with low physical activity, on 24h rhythmicity in energy metabolism as compared to a non-ketogenic, isocaloric control.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
14 (estimated)
First submitted
8 Sept 2025
Start date
25 Nov 2025
Primary completion date
31 Oct 2027
Lead sponsor
Maastricht University Medical Center
Diseases
Obesity
NCT number
NCT07395973

What you commit to

  • Study type: Interventional
  • Planned participants: 14
  • From 25 Nov 2025 to the primary completion date, 31 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Blood donation during or within 2 months prior to the study

Other illness

  • Type 2 diabetes
  • Participants with active congestive heart failure and/or severe renal and or liver insufficiency
  • Uncontrolled hypertension
  • Significant food allergies/intolerance (seriously hampering study meals or study product)

Other

  • 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
  • Participants who do not want to be informed about unexpected medical findings
  • 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)

Who the study is looking for

  • 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)

Age in the registry: 60 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Maastricht University
Coordinator of this site? Confirm its status
MaastrichtNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.