Metabolic SyndromeNCT01618526
ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome
A study testing Western Style Diet and Healthy Carbohydrate Diet in people with Metabolic Syndrome, run by University of Aarhus at 1 site in Denmark.
Trial summary
Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Western Style Diet and Healthy Carbohydrate Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2012to May 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Central obesity (Female > 80 cm, Male > 94 cm)
- HDL cholesterol (Female < 1,03 mmol/L, Male < 1,29 mmol/L)
- Bloodpressure (> 130/85 mmHg)
- Fasting Blood Glucose > 5,6 mmol/L
Who cannot join
- Diabetes
- Gastrointestinal disease
- Serious liver, heart or kidney disease
- Anticoagulation treatment
- Anaemia
- Corticosteroid treatment
Show all 9Show fewer
- Waist circumference above 130 cm
- Alcohol or drug addiction
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon.
In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome are randomized to two types of diet intervention: a low and a high fiber diet. The participants are subjected to endoscopy before and in the end of each intervention.
Read the detailed description
Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon.
In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome are subjected to two types of diet intervention:
- a western style diet, WSD, with a low fiber content and
- a healthy carbohydrate diet, HCD, a high fiber diet. Between the two 4-weeks diet is a wash-out period of four to eight weeks. The participants are subjected to endoscopy with tissue samples before and in the end of each intervention. Fecal and blood samples will be collected at the same time.
We hypothesize that a high content of resistent starch and arabinoxylans increases colonic butyrate concentration, changes colon's mucosal immune system and the microbiota.
A small pilot study will be carried out on 12 healthy volunteers in order to obtain a reference to participants with metabolic syndrome. The healthy volunteers will be subjected to an endoscopy but no dietary intervention.
- Conditions
- Metabolic Syndrome
- Being tested
- Western Style Diet, Healthy Carbohydrate Diet
- Keywords
- Dietary fibers, Butyrate, Short Chain Fatty Acids, Colon, Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western Style DietDietary supplement
Cross over design with two intervention diet: Healthy Carbohydrate Diet with approximally 55 grams of dietary fibers (Arabinoxylans and Resist Starch) compared with a Western Style Diet with a low content of dietary fibers.
Healthy Carbohydrate DietDietary supplement
Cross over design with two intervention diet: Healthy Carbohydrate Diet with approximally 55 grams of dietary fibers ( Arabinoxylans and Resistent Starch) compared with Western Style Diet with low content of dietary fibers
| Study group | Role | What they receive |
|---|---|---|
| Healthy Carbohydrate Diet | Active comparator | 4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch Receives: Dietary Supplement: Healthy Carbohydrate Diet |
| Western Style Diet | Placebo comparator | 4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans. Receives: Dietary Supplement: Western Style Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feces-short chain fatty acids
Concentration of short chain fatty acids
Measured: Baseline and 4 weeks
Secondary outcomes (5)
A change in gut microbiome evaluated by 16 S-RNA analysis
Measured: Baseline and 4 weeks
Change in Nuclear Factor-kappa B (NF-кB) described by gene expression analysis.
Measured: Baseline and 4 weeks
Change in production of pro inflammatory cytokines on mucosal level (IFN-γ, TNF-α, IL-17).
Measured: Baseline and 4 weeks
Change in production of regulatory cytokines on mucosal level and in peripheral blood mononuclear cell (IL-22, IL-10 TNF-β).
Measured: Baseline and 4 weeks
Activation of T-cells in mucosa described by reduced expression of CD25 and CD69.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionMay 2015
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 SyndromeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Knud Erik Bach Knudsen, Professor, Principal investigator, Aarhus University, Department of Animal Sciens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618526
- Sponsor's protocol ID
- V02062012
- Status last verified
- Aug 2013
- First submitted
- 30 May 2012
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hald S, Schioldan AG, Moore ME, Dige A, Laerke HN, Agnholt J, Bach Knudsen KE, Hermansen K, Marco ML, Gregersen S, Dahlerup JF. Effects of Arabinoxylan and Resistant Starch on Intestinal Microbiota and Short-Chain Fatty Acids in Subjects with Metabolic Syndrome: A Randomised Crossover Study. PLoS One. 2016 Jul 19;11(7):e0159223. doi: 10.1371/journal.pone.0159223. eCollection 2016.
PubMed 27434092
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01618526
- Acronym / sponsor ID
- V02062012
- Conditions
- Metabolic Syndrome
- Keywords
- Dietary fibers, Butyrate, Short Chain Fatty Acids, Colon, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Jun 2012 (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.
Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon.
In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome are randomized to two types of diet intervention: a low and a high fiber diet. The participants are subjected to endoscopy before and in the end of each intervention.
Detailed description
Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon.
In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome are subjected to two types of diet intervention:
- a western style diet, WSD, with a low fiber content and
- a healthy carbohydrate diet, HCD, a high fiber diet. Between the two 4-weeks diet is a wash-out period of four to eight weeks. The participants are subjected to endoscopy with tissue samples before and in the end of each intervention. Fecal and blood samples will be collected at the same time.
We hypothesize that a high content of resistent starch and arabinoxylans increases colonic butyrate concentration, changes colon's mucosal immune system and the microbiota.
A small pilot study will be carried out on 12 healthy volunteers in order to obtain a reference to participants with metabolic syndrome. The healthy volunteers will be subjected to an endoscopy but no dietary intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Carbohydrate Diet | Active comparator | Dietary Supplement: Healthy Carbohydrate Diet4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch |
| Western Style Diet | Placebo comparator | Dietary Supplement: Western Style Diet4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Central obesity (Female > 80 cm, Male > 94 cm)
- HDL cholesterol (Female < 1,03 mmol/L, Male < 1,29 mmol/L)
- Bloodpressure (> 130/85 mmHg)
- Fasting Blood Glucose > 5,6 mmol/L
Key exclusion criteria (9 listed)
- Diabetes
- Gastrointestinal disease
- Serious liver, heart or kidney disease
- Anticoagulation treatment
- Anaemia
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 |
|---|---|---|
| Western Style DietCross over design with two intervention diet: Healthy Carbohydrate Diet with approximally 55 grams of dietary fibers (Arabinoxylans and Resist Starch) compared with a Western Style Diet with a low content of dietary fibers. | Dietary supplement | Western Style Diet |
| Healthy Carbohydrate DietCross over design with two intervention diet: Healthy Carbohydrate Diet with approximally 55 grams of dietary fibers ( Arabinoxylans and Resistent Starch) compared with Western Style Diet with low content of dietary fibers | Dietary supplement | Healthy Carbohydrate Diet |
Primary outcome
Feces-short chain fatty acids
Time frame: Baseline and 4 weeks
Concentration of short chain fatty acids
5 secondary outcomes
A change in gut microbiome evaluated by 16 S-RNA analysis
Time frame: Baseline and 4 weeks
Change in Nuclear Factor-kappa B (NF-кB) described by gene expression analysis.
Time frame: Baseline and 4 weeks
Change in production of pro inflammatory cytokines on mucosal level (IFN-γ, TNF-α, IL-17).
Time frame: Baseline and 4 weeks
Change in production of regulatory cytokines on mucosal level and in peripheral blood mononuclear cell (IL-22, IL-10 TNF-β).
Time frame: Baseline and 4 weeks
Activation of T-cells in mucosa described by reduced expression of CD25 and CD69.
Time frame: Baseline and 4 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 29 May 2015.
- Derived from this study: PubMed 27434092Hald S, Schioldan AG, Moore ME, Dige A, Laerke HN, Agnholt J, Bach Knudsen KE, Hermansen K, Marco ML, Gregersen S, Dahlerup JF. Effects of Arabinoxylan and Resistant Starch on Intestinal Microbiota and Short-Chain Fatty Acids in Subjects with Metabolic Syndrome: A Randomised Crossover Study. PLoS One. 2016 Jul 19;11(7):e0159223. doi: 10.1371/journal.pone.0159223. eCollection 2016.
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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.
Knud Erik Bach Knudsen, Professor principal investigator
Aarhus University, Department of Animal Sciens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Western Style Diet and Healthy Carbohydrate Diet in people with Metabolic Syndrome, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 9 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 May 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 Denmark. 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?
Feces-short chain fatty acids (time frame: Baseline and 4 weeks). 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 NCT01618526, 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 May 2015.