Type 2 Diabetes MellitusNCT02009670
Inulin,SCFA Production and Metabolic Response
A study testing 13C inulin in people with Type 2 Diabetes Mellitus and Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In this placebo controlled, double-blind, randomized crossover study the investigators will investigate in overweight/obese healthy male volunteers whether inulin administration will increase intestinal SCFA production, thereby investigating whether this will lead to acute metabolic effects. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity
- What is being tested?
- 13C inulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2014to Jul 2014
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight, obese men
Who cannot join
- athletes
- diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SCFA Production and Their Metabolic Effects After Inulin Ingestion
In this placebo controlled, double-blind, randomized crossover study the investigators will investigate in overweight/obese healthy male volunteers whether inulin administration will increase intestinal SCFA production, thereby investigating whether this will lead to acute metabolic effects.
Read the detailed description
Gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. The role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by microbial fermentation of fibre, is still controversial. At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited. The investigators hypothesize that the ingested prebiotic inulin is fermented into SCFA and these SCFA have metabolic effects.
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Being tested
- 13C inulin, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C inulinDietary supplement
Oral 13C inulin
PlaceboOther
Oral maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| 13C inulin | Experimental | 13C inulin combined with an inulin load are administered orally Receives: Dietary Supplement: 13C inulin |
| Placebo | Placebo comparator | A placebo is administered orally Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat oxidation, energy expenditure
Fat oxidation and energy expenditure are measured after inulin ingestion
Measured: 1 study day for each administration
Secondary outcomes (5)
Hormones that influence substrate and energy metabolism
Insulin, GLP-1, PYY will be measured in plasma after inulin ingestion
Measured: 1 study day for each administration
Circulating metabolites
Glucose, FFA, TG will be measured in plasma after inulin ingestion
Measured: 1 study day for each administration
Appetite VAS scoring
Visual Analogue Scale for hunger and appetite are completed after inulin ingestion
Measured: 1 study day for each administration
SCFAs
SCFA content (acetate, butyrate and propionate, unlabeled and 13C-labeled) are measured after inulin ingestion in plasma, faeces
Measured: 1 study day for each administration
Breath sampling 13CO2
In breath samples 13CO2 will be measured after inulin ingestion
Measured: 1 study day for each administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
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 Type 2 Diabetes MellitusStudies 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
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Sponsor
- Investigators
- CHC Dejong, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009670
- Sponsor's protocol ID
- Inulin and SCFA production
- Status last verified
- Oct 2014
- First submitted
- 9 Dec 2013
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Beek CM, Canfora EE, Kip AM, Gorissen SHM, Olde Damink SWM, van Eijk HM, Holst JJ, Blaak EE, Dejong CHC, Lenaerts K. The prebiotic inulin improves substrate metabolism and promotes short-chain fatty acid production in overweight to obese men. Metabolism. 2018 Oct;87:25-35. doi: 10.1016/j.metabol.2018.06.009. Epub 2018 Jun 25.
PubMed 29953876
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCFA Production and Their Metabolic Effects After Inulin Ingestion
- ClinicalTrials.gov ID
- NCT02009670
- Acronym / sponsor ID
- Inulin and SCFA production
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Dec 2013 (estimated)
- 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 placebo controlled, double-blind, randomized crossover study the investigators will investigate in overweight/obese healthy male volunteers whether inulin administration will increase intestinal SCFA production, thereby investigating whether this will lead to acute metabolic effects.
Detailed description
Gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. The role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by microbial fermentation of fibre, is still controversial. At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited. The investigators hypothesize that the ingested prebiotic inulin is fermented into SCFA and these SCFA have metabolic effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 13C inulin | Experimental | Dietary Supplement: 13C inulin13C inulin combined with an inulin load are administered orally |
| Placebo | Placebo comparator | Other: PlaceboA placebo is administered orally |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Overweight, obese men
Key exclusion criteria (2 listed)
- athletes
- diabetes mellitus
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 |
|---|---|---|
| 13C inulinOral 13C inulin | Dietary supplement | 13C inulin |
| PlaceboOral maltodextrin | Other | Placebo |
Primary outcome
Fat oxidation, energy expenditure
Time frame: 1 study day for each administration
Fat oxidation and energy expenditure are measured after inulin ingestion
5 secondary outcomes
Hormones that influence substrate and energy metabolism
Time frame: 1 study day for each administration
Circulating metabolites
Time frame: 1 study day for each administration
Appetite VAS scoring
Time frame: 1 study day for each administration
SCFAs
Time frame: 1 study day for each administration
Breath sampling 13CO2
Time frame: 1 study day for each administration
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 25 Nov 2015.
- Derived from this study: PubMed 29953876van der Beek CM, Canfora EE, Kip AM, Gorissen SHM, Olde Damink SWM, van Eijk HM, Holst JJ, Blaak EE, Dejong CHC, Lenaerts K. The prebiotic inulin improves substrate metabolism and promotes short-chain fatty acid production in overweight to obese men. Metabolism. 2018 Oct;87:25-35. doi: 10.1016/j.metabol.2018.06.009. Epub 2018 Jun 25.
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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.
CHC Dejong, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 13C inulin in people with Type 2 Diabetes Mellitus 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 1 inclusion and 2 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 25 Nov 2015. 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?
Fat oxidation, energy expenditure (time frame: 1 study day for each administration). 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 NCT02009670, 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 25 Nov 2015.