Overweight and ObesityNCT06511206
Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones
A study testing 25g MCT-based nutrient mix and 25g MCT-based nutrient mix + cofactors in people with Overweight and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
This study will be performed to determine the optimal nutrient mix (predominantly based on medium-chain triglycerides (MCTs)) to induce a mild ketogenic state in healthy older (60-80y), overweight/obese (BMI: 25-35 kg/m2) individuals. 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?
- 25g MCT-based nutrient mix and 25g MCT-based nutrient mix + cofactors
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Aug 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Stable dietary habits (no weight loss or gain > 5 kg in the past 3 months)
- Participants are able to provide signed and dated written informed consent prior to any study specific procedures
Who cannot join
- Type 2 diabetes
- Pre-diabetes based on one or a combination of the following criteria:
- ImpairedFastingGlucose(IFG):Fasting plasma glucose ≥ 6.1mmol/l and ≤ 6.9 mmol/l.
- HbA1c of 5.7-6.4%.
- Participants with active congestive heart failure and/or severe renal and or liver insufficiency
- Uncontrolled hypertension
Show all 12Show fewer
- Alcohol consumption of > 3 servings per day for man and > 2 servings per day for woman
- Unstable body weight (weight gain or loss > 5 kg in the last 3 months)
- 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)
- Participants who do not want to be informed about unexpected medical findings
- Blood donation during or within 2 months prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
This study will be performed to determine the optimal nutrient mix (predominantly based on medium-chain triglycerides (MCTs)) to induce a mild ketogenic state in healthy older (60-80y), overweight/obese (BMI: 25-35 kg/m2) individuals. Since the aim is to induce a mild ketogenic state, a 25g MCT-based nutrient mix, a 25g MCT-based nutrient mix + cofactors, or a non-ketogenic control will be compared.
- Conditions
- Overweight and Obesity
- Being tested
- 25g MCT-based nutrient mix, 25g MCT-based nutrient mix + cofactors, non-ketogenic 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.
25g MCT-based nutrient mixDietary supplement
The 25g MCT-based nutrient mix will be consumed two hours after breakfast.
25g MCT-based nutrient mix + cofactorsDietary supplement
The 25g MCT-based nutrient mix + cofactors will be consumed two hours after breakfast.
non-ketogenic controlDietary supplement
The non-ketogenic control will be consumed two hours after breakfast.
| Study group | Role | What they receive |
|---|---|---|
| 25g MCT-based nutrient mix | Experimental | Not described Receives: Dietary Supplement: 25g MCT-based nutrient mix |
| 25g MCT-based nutrient mix + cofactors | Experimental | Not described Receives: Dietary Supplement: 25g MCT-based nutrient mix + cofactors |
| non-ketogenic control | Placebo comparator | Not described Receives: Dietary Supplement: non-ketogenic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma ketone levels
The primary outcome is plasma ketone levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as area under the curve (AUC).
Measured: Testday 1, 2, and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start8 Aug 2024
- Primary completion27 Mar 2025
- Study completion31 Mar 2025
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
- 11 participants (actual)
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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511206
- Sponsor's protocol ID
- NL86023.068.23
- Status last verified
- Oct 2024
- First submitted
- 20 Jun 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones
- ClinicalTrials.gov ID
- NCT06511206
- Acronym / sponsor ID
- NL86023.068.23
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 19 Jul 2024 (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 be performed to determine the optimal nutrient mix (predominantly based on medium-chain triglycerides (MCTs)) to induce a mild ketogenic state in healthy older (60-80y), overweight/obese (BMI: 25-35 kg/m2) individuals. Since the aim is to induce a mild ketogenic state, a 25g MCT-based nutrient mix, a 25g MCT-based nutrient mix + cofactors, or a non-ketogenic control will be compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25g MCT-based nutrient mix | Experimental | Dietary Supplement: 25g MCT-based nutrient mix |
| 25g MCT-based nutrient mix + cofactors | Experimental | Dietary Supplement: 25g MCT-based nutrient mix + cofactors |
| non-ketogenic control | Placebo comparator | Dietary Supplement: non-ketogenic control |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 60-80 years
- Body mass index (BMI) 25-35 kg/m2
- Stable dietary habits (no weight loss or gain > 5 kg in the past 3 months)
- Participants are able to provide signed and dated written informed consent prior to any study specific procedures
Key exclusion criteria (12 listed)
- Type 2 diabetes
- Pre-diabetes based on one or a combination of the following criteria:
- Participants with active congestive heart failure and/or severe renal and or liver insufficiency
- Uncontrolled hypertension
- Alcohol consumption of > 3 servings per day for man and > 2 servings per day for woman
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 |
|---|---|---|
| 25g MCT-based nutrient mixThe 25g MCT-based nutrient mix will be consumed two hours after breakfast. | Dietary supplement | 25g MCT-based nutrient mix |
| 25g MCT-based nutrient mix + cofactorsThe 25g MCT-based nutrient mix + cofactors will be consumed two hours after breakfast. | Dietary supplement | 25g MCT-based nutrient mix + cofactors |
| non-ketogenic controlThe non-ketogenic control will be consumed two hours after breakfast. | Dietary supplement | non-ketogenic control |
Primary outcome
Plasma ketone levels
Time frame: Testday 1, 2, and 3
The primary outcome is plasma ketone levels determined regularly over a defined time period after ingestion of the respective nutritional supplements, expressed as area under the curve (AUC).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Joris Hoeks, 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 25g MCT-based nutrient mix and 25g MCT-based nutrient mix + cofactors 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 4 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma ketone levels (time frame: Testday 1, 2, and 3). 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 4 Apr 2025.