Type 2 DiabetesNCT06384313
Butyrate-enriched Triglyceride and Diabetes Prevention
A study testing butyrate/hexanoate-enriched triglycerides in people with Type 2 Diabetes and PreDiabetes, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
A body of animal studies as well as observational studies in humans demonstrated that butyrate is one SCFA that has pronounced positive effects on body weight control, inflammation, and insulin resistance. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, PreDiabetes, Obesity
- What is being tested?
- butyrate/hexanoate-enriched triglycerides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Sep 2024to 25 Sep 2026
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age 20-70 years
- BMI ≥ 28 and < 40 kg/m2
- Weight stable for at least 3 months
- Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
- One or more of the following criteria to determine disturbed glucose/insulin homeostasis
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- Fasting glucose 5.6-6.9 mmol/L
- Two-hour glucose of 7.8-11.1 mmol/L
- HOMA-IR ≥ 2.2
- HbA1c (5.7-6.4%)
Who cannot join
- Diabetes mellitus (type 1 or 2)
- Cardiovascular disease: including no history or myocardial infarction, heart failure, arrhythmias
- Pulmonary disease: no history of chronic obstructive pulmonary disease, emphysema, bronchitis, asthma
- Kidney (e.g. kidney failure) or liver (e.g. cirrhosis, non-alcoholic fatty acid) malfunction
- Gastrointestinal disease (no inflammatory bowel disease, irritable bowel syndrome or digestive disorders) or a history of abdominal surgery (except appendectomy and cholecystectomy)
- Autoimmune disease
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- Any other diseases affecting glucose and/or lipid metabolism or use of any medication that influence glucose or fat metabolism and inflammation
- Ongoing disease or any disease with a life expectancy ≤ 5 years
- Abuse of products; alcohol (>15 units per week) and drugs, excessive nicotine use defined as >20 cigarettes per week
- Regular supplementation of pre- or probiotic products, use of pre- or probiotics, antibiotics and laxatives 3 months prior to the start of the study
- Intensive exercise training more than three hours a week
- Plan to lose weight or to follow a hypocaloric diet or vegetarian diet
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Diabetes With a Novel Butyrate-enriched Triglyceride
A body of animal studies as well as observational studies in humans demonstrated that butyrate is one SCFA that has pronounced positive effects on body weight control, inflammation, and insulin resistance. Even though the SCFA hexanoate is less researched, it has been shown to be involved in anti-inflammatory processes. Of note, acute human studies showed that fibre-induced metabolic improvements are linked to higher SCFA levels in the systemic circulation. It has been shown that a butyrate/hexanoate-enriched triglyceride oil enhanced systemic butyrate and hexanoate concentrations for a prolonged time. Yet, it remains to be determined whether a chronic increase in circulating butyrate and hexanoate concentrations translate into long-term benefits. In this study it is hypothesized that a chronic increase of butyrate/hexanoate in the circulation may improve host metabolism and metabolic health by improving adipose tissue function, reducing systemic lipid overflow and inflammation thereby increasing peripheral insulin sensitivity in individual with overweight/obesity and prediabetes.
- Conditions
- Type 2 Diabetes, PreDiabetes, Obesity
- Being tested
- butyrate/hexanoate-enriched triglycerides
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
butyrate/hexanoate-enriched triglyceridesDietary supplement
The oils are consumed two times a day for 24 weeks (six months).
| Study group | Role | What they receive |
|---|---|---|
| butyrate/hexanoate-enriched triglycerides | Experimental | Oil containing butyrate and hexanoate-enriched triglycerides Receives: Dietary Supplement: butyrate/hexanoate-enriched triglycerides |
| placebo | Placebo comparator | Oil devoid of butyrate and hexanoate but with similar composition as the intervention oil Receives: Dietary Supplement: butyrate/hexanoate-enriched triglycerides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral insulin sensitivity
The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
Measured: Before and 6 months after the start of the intervention
Secondary outcomes (12)
hepatic insulin sensitivity
The change in hepatic insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
Measured: Before and 6 months after the start of the intervention
adipose tissue insulin sensitivity
The change in adipose tissue insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
Measured: Before and 6 months after the start of the intervention
Energy expenditure (indirect calorimetry)
The change in energy expenditure as measured via ventilated hood system
Measured: Before and 6 months after the start of the intervention
Substrate oxidation (indirect calorimetry)
The change in substrate oxidation as measured via ventilated hood system
Measured: Before and 6 months after the start of the intervention
circulating SCFA
The change in concentrations of circulating SCFA
Measured: Before and 6 months after the start of the intervention
Faecal SCFA
The change in concentrations of faecal SCFA
Measured: Before and 6 months after the start of the intervention
Faecal microbiota composition
The change in faecal microbiota composition assessing abundances of bacteria and diversity indices as assessed via 16s rRNA gene
Measured: Before and 6 months after the start of the intervention
Circulating hormones such as insulin
The change in concentrations of circulating hormones in peripheral blood
Measured: Before and 6 months after the start of the intervention
Circulating metabolites such as glucose
The change in concentrations of metabolites in peripheral blood
Measured: Before and 6 months after the start of the intervention
body composition
The change in body composition as assessed using DEXA scans
Measured: Before and 6 months after the start of the intervention
body weight
The change in body weight in kg using a weight scale
Measured: Before and 6 months after the start of the intervention
Gut permeability
The change in gut permeability as assessed using a multi-sugar test
Measured: Before and 6 months after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start19 Sep 2024
- Primary completion25 Sep 2026
- Study completion25 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384313
- Sponsor's protocol ID
- NL86266.068.24
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Diabetes With a Novel Butyrate-enriched Triglyceride
- ClinicalTrials.gov ID
- NCT06384313
- Acronym / sponsor ID
- NL86266.068.24
- Conditions
- Type 2 Diabetes, PreDiabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 25 Sep 2026 (actual)
- First posted
- 25 Apr 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.
A body of animal studies as well as observational studies in humans demonstrated that butyrate is one SCFA that has pronounced positive effects on body weight control, inflammation, and insulin resistance. Even though the SCFA hexanoate is less researched, it has been shown to be involved in anti-inflammatory processes. Of note, acute human studies showed that fibre-induced metabolic improvements are linked to higher SCFA levels in the systemic circulation. It has been shown that a butyrate/hexanoate-enriched triglyceride oil enhanced systemic butyrate and hexanoate concentrations for a prolonged time. Yet, it remains to be determined whether a chronic increase in circulating butyrate and hexanoate concentrations translate into long-term benefits. In this study it is hypothesized that a chronic increase of butyrate/hexanoate in the circulation may improve host metabolism and metabolic health by improving adipose tissue function, reducing systemic lipid overflow and inflammation thereby increasing peripheral insulin sensitivity in individual with overweight/obesity and prediabetes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| butyrate/hexanoate-enriched triglycerides | Experimental | Dietary Supplement: butyrate/hexanoate-enriched triglyceridesOil containing butyrate and hexanoate-enriched triglycerides |
| placebo | Placebo comparator | Dietary Supplement: butyrate/hexanoate-enriched triglyceridesOil devoid of butyrate and hexanoate but with similar composition as the intervention oil |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age 20-70 years
- BMI ≥ 28 and < 40 kg/m2
- Weight stable for at least 3 months
- Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
Key exclusion criteria (13 listed)
- Diabetes mellitus (type 1 or 2)
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 |
|---|---|---|
| butyrate/hexanoate-enriched triglyceridesThe oils are consumed two times a day for 24 weeks (six months). | Dietary supplement | butyrate/hexanoate-enriched triglycerides, placebo |
Primary outcome
Peripheral insulin sensitivity
Time frame: Before and 6 months after the start of the intervention
The change of peripheral insulin sensitivity as assessed by a hyperinsulinaemic-euglycemic clamp
12 secondary outcomes
hepatic insulin sensitivity
Time frame: Before and 6 months after the start of the intervention
adipose tissue insulin sensitivity
Time frame: Before and 6 months after the start of the intervention
Energy expenditure (indirect calorimetry)
Time frame: Before and 6 months after the start of the intervention
Substrate oxidation (indirect calorimetry)
Time frame: Before and 6 months after the start of the intervention
circulating SCFA
Time frame: Before and 6 months after the start of the intervention
Faecal SCFA
Time frame: Before and 6 months after the start of the intervention
Faecal microbiota composition
Time frame: Before and 6 months after the start of the intervention
Circulating hormones such as insulin
Time frame: Before and 6 months after the start of the intervention
Circulating metabolites such as glucose
Time frame: Before and 6 months after the start of the intervention
body composition
Time frame: Before and 6 months after the start of the intervention
body weight
Time frame: Before and 6 months after the start of the intervention
Gut permeability
Time frame: Before and 6 months after the start of the intervention
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 28 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing butyrate/hexanoate-enriched triglycerides in people with Type 2 Diabetes and PreDiabetes, 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 10 inclusion and 13 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 28 Oct 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?
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?
Peripheral insulin sensitivity (time frame: Before and 6 months after the start of the intervention). 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 28 Oct 2026.