Metabolic DiseaseNCT04662411
Butyrate/Hexanoate in Metabolic Health
A study testing butyrate and hexanoate amount 1, butyrate and hexanoate amount 2 and butyrate and hexanoate amount 3 in people with Metabolic Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In this study, we aim to identify a well consumable butyrate/hexanoate-enriched oil that increases circulating SCFA concentrations and improves postprandial substrate metabolism, which could be further used for a long-term study. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- butyrate and hexanoate amount 1, butyrate and hexanoate amount 2 and butyrate and hexanoate amount 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jan 2021to 26 Jul 2021
- 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 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight/obese men (BMI ≥ 25 kg/m2 and ≤ 34.9 kg/m2);
- Aged 40 - 70 years;
- Caucasian;
- Normal blood pressure (systolic blood pressure 100-140mmHg, diastolic blood pressure 60-90 mmHg);
- Weight stable for at least 3 months (± 2 kg).
Who cannot join
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.1 mmol/L)
- Gastroenterological diseases or abdominal surgery (gallbladder removal and appendix removal are allowed)
- Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- Lactose intolerance or other disorders that affect digestion (such as celiac disease)
- Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day; and excessive alcohol use defined as (> 15 units/week)
- Plans to lose weight or following of a hypocaloric diet in the following three months;
Show all 12Show fewer
- Regular supplementation of pre- or probiotic products (for example Yakult, Activia), use of pre- or probiotics 3 months prior to the start of the study;
- Intensive exercise training more than three hours a week;
- Use of any medication that influences glucose or fat metabolism and inflammation (i.e. betablockers, corticosteroids, statins or NSAIDs);
- Regular use of laxation products in 3 months prior start of study or during study period;
- Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
- Follow a vegan diet or vegetarian diet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Butyrate/Hexanoate-enriched Triglycerides for Metabolic Health
In this study, we aim to identify a well consumable butyrate/hexanoate-enriched oil that increases circulating SCFA concentrations and improves postprandial substrate metabolism, which could be further used for a long-term study.
- Conditions
- Metabolic Disease
- Being tested
- Placebo, butyrate and hexanoate amount 1, butyrate and hexanoate amount 2, butyrate and hexanoate amount 3
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
acute intake of 0 mg butyrate and hexanoate
butyrate and hexanoate amount 1Dietary supplement
acute intake of 650 mg butyrate and hexanoate
butyrate and hexanoate amount 2Dietary supplement
acute intake of 1325 mg butyrate and hexanoate
butyrate and hexanoate amount 3Dietary supplement
acute intake of 2000 mg butyrate and hexanoate
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| butyrate and hexanoate amount 1 | Experimental | 1325 mg of butyrate and hexanoate Receives: Dietary Supplement: butyrate and hexanoate amount 1 |
| butyrate and hexanoate amount 2 | Experimental | Not described Receives: Dietary Supplement: butyrate and hexanoate amount 2 |
| butyrate and hexanoate amount 3 | Experimental | Not described Receives: Dietary Supplement: butyrate and hexanoate amount 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma butyrate concentrations
Plasma butyrate concentrations
Measured: Fasting and postprandial butyrate will be measured before and up to 6 hours after intake of the supplement
Secondary outcomes (6)
Circulating Glucose
Circulating Glucose assessed in plasma
Measured: Fasting and postprandial glucose will be measured before and up to 6 hours after intake of the supplement
Circulating Free Fatty Acids
Circulating Free Fatty Acids assessed in plasma
Measured: Fasting and postprandial Free Fatty Acids will be measured before and up to 6 hours after intake of the supplement
Circulating Glycerol
Circulating Glycerol assessed in plasma
Measured: Fasting and postprandial Glycerol will be measured before and up to 6 hours after intake of the supplement
Circulating Triglycerides (TG)
Circulating Triglycerides assessed in plasma
Measured: Fasting and postprandial TG will be measured before and up to 6 hours after intake of the supplement
Circulating insulin
Circulating . insulin will be assessed in plasma
Measured: Fasting and postprandial insulin will be measured before and up to 6 hours after intake of the supplement
Breath H2
Breath H2 using Gastrolyzer
Measured: Fasting and postprandial breath H2 will be measured before and up to 6 hours after intake of the supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start13 Jan 2021
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseaseStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 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
- NCT04662411
- Sponsor's protocol ID
- NL75253.068.20
- Status last verified
- Nov 2021
- First submitted
- 4 Dec 2020
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Deuren T, Smolders L, Hartog A, Bouwman FG, Holst JJ, Venema K, Blaak EE, Canfora EE. Butyrate and hexanoate-enriched triglycerides increase postprandrial systemic butyrate and hexanoate in men with overweight/obesity: A double-blind placebo-controlled randomized crossover trial. Front Nutr. 2023 Jan 4;9:1066950. doi: 10.3389/fnut.2022.1066950. eCollection 2022.
PubMed 36687671
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Butyrate/Hexanoate-enriched Triglycerides for Metabolic Health
- ClinicalTrials.gov ID
- NCT04662411
- Acronym / sponsor ID
- NL75253.068.20
- Conditions
- Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 10 Dec 2020 (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.
In this study, we aim to identify a well consumable butyrate/hexanoate-enriched oil that increases circulating SCFA concentrations and improves postprandial substrate metabolism, which could be further used for a long-term study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| butyrate and hexanoate amount 1 | Experimental | Dietary Supplement: butyrate and hexanoate amount 11325 mg of butyrate and hexanoate |
| butyrate and hexanoate amount 2 | Experimental | Dietary Supplement: butyrate and hexanoate amount 2 |
| butyrate and hexanoate amount 3 | Experimental | Dietary Supplement: butyrate and hexanoate amount 3 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Overweight/obese men (BMI ≥ 25 kg/m2 and ≤ 34.9 kg/m2);
- Aged 40 - 70 years;
- Caucasian;
- Normal blood pressure (systolic blood pressure 100-140mmHg, diastolic blood pressure 60-90 mmHg);
- Weight stable for at least 3 months (± 2 kg).
Key exclusion criteria (12 listed)
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.1 mmol/L)
- Gastroenterological diseases or abdominal surgery (gallbladder removal and appendix removal are allowed)
- Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- Lactose intolerance or other disorders that affect digestion (such as celiac disease)
- Abuse of products; alcohol and drugs, excessive nicotine use defined as >20 cigarettes per day; and excessive alcohol use defined as (> 15 units/week)
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 |
|---|---|---|
| Placeboacute intake of 0 mg butyrate and hexanoate | Dietary supplement | Placebo |
| butyrate and hexanoate amount 1acute intake of 650 mg butyrate and hexanoate | Dietary supplement | butyrate and hexanoate amount 1 |
| butyrate and hexanoate amount 2acute intake of 1325 mg butyrate and hexanoate | Dietary supplement | butyrate and hexanoate amount 2 |
| butyrate and hexanoate amount 3acute intake of 2000 mg butyrate and hexanoate | Dietary supplement | butyrate and hexanoate amount 3 |
Primary outcome
Plasma butyrate concentrations
Time frame: Fasting and postprandial butyrate will be measured before and up to 6 hours after intake of the supplement
Plasma butyrate concentrations
6 secondary outcomes
Circulating Glucose
Time frame: Fasting and postprandial glucose will be measured before and up to 6 hours after intake of the supplement
Circulating Free Fatty Acids
Time frame: Fasting and postprandial Free Fatty Acids will be measured before and up to 6 hours after intake of the supplement
Circulating Glycerol
Time frame: Fasting and postprandial Glycerol will be measured before and up to 6 hours after intake of the supplement
Circulating Triglycerides (TG)
Time frame: Fasting and postprandial TG will be measured before and up to 6 hours after intake of the supplement
Circulating insulin
Time frame: Fasting and postprandial insulin will be measured before and up to 6 hours after intake of the supplement
Breath H2
Time frame: Fasting and postprandial breath H2 will be measured before and up to 6 hours after intake of the supplement
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 29 Nov 2021.
- Derived from this study: PubMed 36687671van Deuren T, Smolders L, Hartog A, Bouwman FG, Holst JJ, Venema K, Blaak EE, Canfora EE. Butyrate and hexanoate-enriched triglycerides increase postprandrial systemic butyrate and hexanoate in men with overweight/obesity: A double-blind placebo-controlled randomized crossover trial. Front Nutr. 2023 Jan 4;9:1066950. doi: 10.3389/fnut.2022.1066950. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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 and hexanoate amount 1, butyrate and hexanoate amount 2 and butyrate and hexanoate amount 3 in people with Metabolic Disease, 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 5 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 29 Nov 2021. 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 butyrate concentrations (time frame: Fasting and postprandial butyrate will be measured before and up to 6 hours after intake of the supplement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04662411, which also lists 1 linked publication.
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 29 Nov 2021.