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NCT Number: NCT07395973

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

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ketogenic nutritional Supplement

Dietary Supplement

Daily ketogenic nutritional supplement for 4 weeks

non-ketogenic, isocaloric control

Dietary Supplement

Daily control for 4 weeks

Primary outcomes

  1. Delta respiratory exchange ratio (from 23:00 till 04:00)

    Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

    Measured with indirect calorimetry

Secondary outcomes

  1. Skeletal mitochondrial function

    Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

    Measured in muscle biopsy

Other outcomes

  1. Protein and gene markers of skeletal muscle metabolism

    Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

    Measured in muscle biopsy

  2. Metabolic blood markers

    Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

    Measured in blood samples

  3. Interstitial ketone levels

    Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

    Measured with a continuous ketone monitor

  4. Interstitial glucose levels

    Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

    Measured with a continuous glucose monitor

  5. Whole body substrate utilization

    Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

    Measured with indirect calorimetry

  6. Whole body energy expenditure

    Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

    Measured with indirect calorimetry

  7. Physical performances

    Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

    Measured with 6-minute walk test, chair-stand-test, and handgrip strength test

  8. Cognitive performance

    Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

    Measured using Cambridge Neuropsychological Test Automated Battery (CANTAB) and cerebral perfusion measured with transcranial doppler ultrasound

  9. Other perceivable benefits: microvasculature

    Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

    Measured with retinal images

  10. Other perceivable benefits: sleep quality

    Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

    Measured with sleep quality questionnaires

  11. Body composition

    Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control

    Measured with BodPod

Study contacts

Contact information is provided by the study sponsor or research team.

Joris Hoeks, Dr.

CONTACT

Merel Timmermans, MSc

CONTACT

[email protected]

0031 88 3887793

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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