ObesityNCT03711383
Inulin and Acetate Production and Human Substrate Metabolism
A study testing Inulin and Resistant Starch and Inulin in people with Obesity and Pre Diabetes, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Based on our hypothesis that orally administered resistant starch and inulin/beta glucan will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective: To investigate the effects of an… Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Pre Diabetes
- What is being tested?
- Inulin and Resistant Starch and Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Feb 2018to 15 Nov 2018
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2)
- normoglycemic
- aged 30 - 65 years
- OR
- overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2)
- pre-diabetes
- aged between 30 - 65 years.
Who cannot join
- diabetes mellitus
- gastroenterological diseases or major abdominal surgery (allowed i.e.: - appendectomy, cholecystectomy)
- lactose intolerance and other digestive disorders
- cardiovascular disease, cancer, liver or kidney malfunction (determined -based on ALAT and creatinine levels, respectively)
- disease with a life expectancy shorter than 5 years
- Use of antibiotics 3 months prior inclusion
- Use of probiotics or prebiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Inulin on Acetate Production and Human Substrate Metabolism
Based on our hypothesis that orally administered resistant starch and inulin/beta glucan will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective:
To investigate the effects of an acute administration of inulin/beta glucan in combination with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.
- Conditions
- Obesity, Pre Diabetes
- Being tested
- Inulin and Resistant Starch, Inulin, Placebo
- Medical subject headings
- Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inulin and Resistant StarchDietary supplement
12g per inulin in combination 7.5 g resistant starch per day the day before the CID Resistant starch 7.5 g
InulinDietary supplement
12g per inulin in combination with maltodextrin per day the day before the CID
PlaceboDietary supplement
isocaloric maltodextrin before test day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | isocaloric maltodextrin the day before CIDs Receives: Dietary Supplement: Placebo |
| Inulin | Active comparator | 12 g of inulin + isocaloric maltodextrin the day before CID Receives: Dietary Supplement: Inulin |
| Inulin and Resistant Starch | Experimental | 12 g inulin + 7.5 g resistant starch the day before CID Receives: Dietary Supplement: Inulin and Resistant Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma acetate concentrations (microM)
Measured: At baseline and up to four hours after a high-fat mixed meal of each CID
Secondary outcomes (6)
Energy expenditure (in kJ/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
Measured: At baseline and up to four hours after a high-fat mixed meal of each CID
Fat oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
Measured: At baseline and up to four hours after a high-fat mixed meal of each CID
Carbohydrate oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
Measured: At baseline and up to four hours after a high-fat mixed meal of each CID
Circulating hormone concentrations (Insulin, GLP-1, PYY)
Measured: At baseline and up to four hours after a high-fat mixed meal of each CID
Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides)
Measured: At baseline and up to four hours after a high-fat mixed meal of each CID
Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)
Measured: At baseline and up to four hours after a high-fat mixed meal of each CID
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start20 Feb 2018
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT03711383
- Sponsor's protocol ID
- NL63754.068.17
- Status last verified
- Oct 2018
- First submitted
- 6 Jul 2018
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Canfora EE, Hermes GDA, Muller M, Bastings J, Vaughan EE, van Den Berg MA, Holst JJ, Venema K, Zoetendal EG, Blaak EE. Fiber mixture-specific effect on distal colonic fermentation and metabolic health in lean but not in prediabetic men. Gut Microbes. 2022 Jan-Dec;14(1):2009297. doi: 10.1080/19490976.2021.2009297.
PubMed 34923911
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inulin on Acetate Production and Human Substrate Metabolism
- ClinicalTrials.gov ID
- NCT03711383
- Acronym / sponsor ID
- NL63754.068.17
- Conditions
- Obesity, Pre Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 18 Oct 2018 (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.
Based on our hypothesis that orally administered resistant starch and inulin/beta glucan will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective:
To investigate the effects of an acute administration of inulin/beta glucan in combination with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboisocaloric maltodextrin the day before CIDs |
| Inulin | Active comparator | Dietary Supplement: Inulin12 g of inulin + isocaloric maltodextrin the day before CID |
| Inulin and Resistant Starch | Experimental | Dietary Supplement: Inulin and Resistant Starch12 g inulin + 7.5 g resistant starch the day before CID |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2)
- normoglycemic
- aged 30 - 65 years
- OR
- overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2)
Key exclusion criteria (7 listed)
- diabetes mellitus
- gastroenterological diseases or major abdominal surgery (allowed i.e.: - appendectomy, cholecystectomy)
- lactose intolerance and other digestive disorders
- cardiovascular disease, cancer, liver or kidney malfunction (determined -based on ALAT and creatinine levels, respectively)
- disease with a life expectancy shorter than 5 years
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 |
|---|---|---|
| Inulin and Resistant Starch12g per inulin in combination 7.5 g resistant starch per day the day before the CID Resistant starch 7.5 g | Dietary supplement | Inulin and Resistant Starch |
| Inulin12g per inulin in combination with maltodextrin per day the day before the CID | Dietary supplement | Inulin |
| Placeboisocaloric maltodextrin before test day | Dietary supplement | Placebo |
Primary outcome
Plasma acetate concentrations (microM)
Time frame: At baseline and up to four hours after a high-fat mixed meal of each CID
6 secondary outcomes
Energy expenditure (in kJ/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
Time frame: At baseline and up to four hours after a high-fat mixed meal of each CID
Fat oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
Time frame: At baseline and up to four hours after a high-fat mixed meal of each CID
Carbohydrate oxidation (in g/min) using an open-circuit ventilated hood system (Omnical, Maastricht University, The Netherlands)
Time frame: At baseline and up to four hours after a high-fat mixed meal of each CID
Circulating hormone concentrations (Insulin, GLP-1, PYY)
Time frame: At baseline and up to four hours after a high-fat mixed meal of each CID
Circulating metabolite concentrations (Glucose, Free Fatty Acids, Triglycerides)
Time frame: At baseline and up to four hours after a high-fat mixed meal of each CID
Breath H2 using (Bedfont EC60 Gastrolyzer, Rochester, UK)
Time frame: At baseline and up to four hours after a high-fat mixed meal of each CID
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 14 Jan 2020.
- Derived from this study: PubMed 34923911Canfora EE, Hermes GDA, Muller M, Bastings J, Vaughan EE, van Den Berg MA, Holst JJ, Venema K, Zoetendal EG, Blaak EE. Fiber mixture-specific effect on distal colonic fermentation and metabolic health in lean but not in prediabetic men. Gut Microbes. 2022 Jan-Dec;14(1):2009297. doi: 10.1080/19490976.2021.2009297.
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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 Inulin and Resistant Starch and Inulin in people with Obesity and Pre Diabetes, 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 7 inclusion and 7 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 14 Jan 2020. 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 acetate concentrations (microM) (time frame: At baseline and up to four hours after a high-fat mixed meal of each CID). 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 NCT03711383, 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 14 Jan 2020.