Metabolic SyndromeNCT02623777
Effect of Arabinoxylan Oligosaccharides Consumption on Insulin Resistance in Patients With Metabolic Syndrome
A study testing Arabinoxylan oligosaccharides and Short chain fatty acids in people with Metabolic Syndrome, run by KU Leuven.
Trial summary
During this project the investigators will evaluate whether the effects of arabinoxylan oligosaccharides (AXOS) consumption on insulin resistance in participants with metabolic syndrome can be explained by the production of short-chain fatty acids (SCFA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Arabinoxylan oligosaccharides and Short chain fatty acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Nov 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Regular diet (3 meals/day on at least 5 days/week)
- Central obese (defined as waist circumference ≥ 94cm for Europid men and ≥ 80cm for Europid women, with ethnicity specific values for other groups)
- Insulin resistant: HOMA-IR > 1.7 or fasting glucose > 100mg/dL
- And one of the following three factors:
- Elevated TG level: ≥ 150 mg/dL (1.7 mmol/L)
- Decreased HDL cholesterol level: < 40 mg/dL (1.03 mmol/L*) in males and < 50 mg/dL (1.29 mmol/L*) in females
- Elevated blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg
Who cannot join
- Low calorie diet or other special diet during the study or during the last month prior to the study
- Serious chronic disease of the gastrointestinal tract, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), irritable bowel syndrome, chronic constipation (less than 3 bowel movements a week), chronic frequent diarrhoea (more than 3 stools a day), clinically relevant lactose intolerance, …
- Use of antibiotics during the last month before starting the study
- Abdominal surgery in the past (except from appendectomy)
- Use of medication that affects the gastro-intestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication, and/or pre- or probiotic supplements (e.g. lacteol, Enterol)
- Pregnancy, pregnancy desire or lactation
- Diabetes (type 1 or 2), i.e. HbA1c > 6.5 %
- Abnormal haemoglobin (Hb) levels in blood, men must have an Hb level between 14.0 and 18.0 g / dL and women between 12.0 and 16.0 g / dL.
About this study
Official title: Evaluation of the Effect of Arabinoxylan Oligosaccharides Consumption on Insulin Resistance in Patients With Metabolic Syndrome and the Contribution of Short-chain Fatty Acids Production
During this project the investigators will evaluate whether the effects of arabinoxylan oligosaccharides (AXOS) consumption on insulin resistance in participants with metabolic syndrome can be explained by the production of short-chain fatty acids (SCFA). Secondly, the investigators will evaluate whether changes in gut hormone production might explain the effect on insulin resistance.
- Conditions
- Metabolic Syndrome
- Being tested
- Arabinoxylan oligosaccharides, Short chain fatty acids
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arabinoxylan oligosaccharidesDietary supplement
Also called AXOS
Arabinoxylan oligosaccharides administered
Short chain fatty acidsDietary supplement
Also called SCFA
Short chain fatty acids administered
| Study group | Role | What they receive |
|---|---|---|
| AXOS as first intervention | Experimental | AXOS as first intervention Receives: Dietary Supplement: Arabinoxylan oligosaccharides; Dietary Supplement: Short chain fatty acids |
| SCFA as first intervention | Experimental | SCFA as first intervention Receives: Dietary Supplement: Arabinoxylan oligosaccharides; Dietary Supplement: Short chain fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin resistance after both interventions using the homeostatic model assessment for insulin resistance
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623777
- Sponsor's protocol ID
- s57413
- Status last verified
- Dec 2015
- First submitted
- 28 Nov 2015
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Arabinoxylan Oligosaccharides Consumption on Insulin Resistance in Patients With Metabolic Syndrome and the Contribution of Short-chain Fatty Acids Production
- ClinicalTrials.gov ID
- NCT02623777
- Acronym / sponsor ID
- s57413
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 8 Dec 2015 (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.
During this project the investigators will evaluate whether the effects of arabinoxylan oligosaccharides (AXOS) consumption on insulin resistance in participants with metabolic syndrome can be explained by the production of short-chain fatty acids (SCFA). Secondly, the investigators will evaluate whether changes in gut hormone production might explain the effect on insulin resistance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXOS as first intervention | Experimental | Dietary Supplement: Arabinoxylan oligosaccharides, Dietary Supplement: Short chain fatty acidsAXOS as first intervention |
| SCFA as first intervention | Experimental | Dietary Supplement: Arabinoxylan oligosaccharides, Dietary Supplement: Short chain fatty acidsSCFA as first intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 65 years
- Regular diet (3 meals/day on at least 5 days/week)
- Central obese (defined as waist circumference ≥ 94cm for Europid men and ≥ 80cm for Europid women, with ethnicity specific values for other groups)
- Insulin resistant: HOMA-IR > 1.7 or fasting glucose > 100mg/dL
- And one of the following three factors:
Key exclusion criteria (8 listed)
- Low calorie diet or other special diet during the study or during the last month prior to the study
- Serious chronic disease of the gastrointestinal tract, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), irritable bowel syndrome, chronic constipation (less than 3 bowel movements a week), chronic frequent diarrhoea (more than 3 stools a day), clinically relevant lactose intolerance, …
- Use of antibiotics during the last month before starting the study
- Abdominal surgery in the past (except from appendectomy)
- Use of medication that affects the gastro-intestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication, and/or pre- or probiotic supplements (e.g. lacteol, Enterol)
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 |
|---|---|---|
| Arabinoxylan oligosaccharidesAlso: AXOSArabinoxylan oligosaccharides administered | Dietary supplement | AXOS as first intervention, SCFA as first intervention |
| Short chain fatty acidsAlso: SCFAShort chain fatty acids administered | Dietary supplement | AXOS as first intervention, SCFA as first intervention |
Primary outcome
Change in insulin resistance after both interventions using the homeostatic model assessment for insulin resistance
Time frame: 2 weeks
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 8 Dec 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Arabinoxylan oligosaccharides and Short chain fatty acids in people with Metabolic Syndrome, run by KU Leuven.
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 8 inclusion and 8 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 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change in insulin resistance after both interventions using the homeostatic model assessment for insulin resistance (time frame: 2 weeks). 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 8 Dec 2015.