The Effects of a 4-week Supplementation With a Ketogenic Nutrient Mix on 24-hour Substrate Metabolism and Muscle Health
1 other identifier
interventional
14
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2025
CompletedStudy Start
First participant enrolled
November 25, 2025
CompletedFirst Posted
Study publicly available on registry
February 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
February 9, 2026
February 1, 2026
1.9 years
September 8, 2025
February 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Delta respiratory exchange ratio (from 23:00 till 04:00)
Measured with indirect calorimetry
Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control
Secondary Outcomes (1)
Skeletal mitochondrial function
Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control
Other Outcomes (11)
Protein and gene markers of skeletal muscle metabolism
Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control
Metabolic blood markers
Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control
Interstitial ketone levels
Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control
- +8 more other outcomes
Study Arms (2)
Ketogenic nutritional supplement
EXPERIMENTALDaily ketogenic nutritional supplement for 4 weeks
non-ketogenic, isocaloric control
PLACEBO COMPARATORDaily control for 4 weeks
Interventions
Daily ketogenic nutritional supplement for 4 weeks
Daily control for 4 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University
Maastricht, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joris Hoeks, Dr.
Maastricht University
- PRINCIPAL INVESTIGATOR
Peter Joris, Dr.
Maastricht University
Central Study Contacts
Joris Hoeks, Dr.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2025
First Posted
February 9, 2026
Study Start
November 25, 2025
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
February 9, 2026
Record last verified: 2026-02