Overweight and ObesityNCT07395973
The Effects of a 4-week Supplementation With a Ketogenic Nutrient Mix on 24-hour Substrate Metabolism and Muscle Health
A study testing ketogenic nutritional Supplement in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- ketogenic nutritional Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Nov 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joris Hoeks, Dr. contact
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht
About this study
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.
- Conditions
- Overweight and Obesity
- Being tested
- ketogenic nutritional Supplement, non-ketogenic, isocaloric control
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketogenic nutritional SupplementDietary supplement
Daily ketogenic nutritional supplement for 4 weeks
non-ketogenic, isocaloric controlDietary supplement
Daily control for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic nutritional supplement | Experimental | Daily ketogenic nutritional supplement for 4 weeks Receives: Dietary Supplement: ketogenic nutritional Supplement |
| non-ketogenic, isocaloric control | Placebo comparator | Daily control for 4 weeks Receives: Dietary Supplement: non-ketogenic, isocaloric control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta respiratory exchange ratio (from 23:00 till 04:00)
Measured with indirect calorimetry
Measured: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control
Secondary outcomes (1)
Skeletal mitochondrial function
Measured in muscle biopsy
Measured: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start25 Nov 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joris Hoeks, Dr., Principal investigator, Maastricht UniversityPeter Joris, Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395973
- Sponsor's protocol ID
- NL-009725
- Status last verified
- Feb 2026
- First submitted
- 8 Sep 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a 4-week Supplementation With a Ketogenic Nutrient Mix on 24-hour Substrate Metabolism and Muscle Health
- ClinicalTrials.gov ID
- NCT07395973
- Acronym / sponsor ID
- NL-009725
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic nutritional supplement | Experimental | Dietary Supplement: ketogenic nutritional SupplementDaily ketogenic nutritional supplement for 4 weeks |
| non-ketogenic, isocaloric control | Placebo comparator | Dietary Supplement: non-ketogenic, isocaloric controlDaily control for 4 weeks |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketogenic nutritional SupplementDaily ketogenic nutritional supplement for 4 weeks | Dietary supplement | Ketogenic nutritional supplement |
| non-ketogenic, isocaloric controlDaily control for 4 weeks | Dietary supplement | non-ketogenic, isocaloric control |
Primary outcome
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
1 secondary outcome
Skeletal mitochondrial function
Time frame: Measured after 4 weeks of daily supplementation with a ketogenic nutritional supplement or non-ketogenic, isocaloric control
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joris Hoeks, Dr. contact
Joris Hoeks, Dr. principal investigator
Maastricht University
Peter Joris, Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketogenic nutritional Supplement in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merel Timmermans, MSc (0031 88 3887793, merel.timmermans@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.