ObesityNCT01877044
Long-term Effects of Arabinoxylans on Intestinal Barrier Function
A study testing NAXUS in people with Obesity and Overweight, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The higher prevalence of overweight and obesity among the population contributes to increased incidences of chronic metabolic diseases. Obesity is considered a low-grade systemic inflammatory condition through 1) production of pro-inflammatory cytokines by adipose tissue and 2) alterations in intestinal microbiota… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- NAXUS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to Jan 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight men/women (BMI 28-35 kg/m2)
- Besides overweight, healthy human beings
- Fasting glucose <7.0 mmol/L
- Normal HbA1c (4.4 to 6.2%)
- Consistently stable body weight for at least 6 months (± 2 kg)
Who cannot join
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L);
- Gastroenterological diseases or abdominal surgery;
- Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- Abuse of products; alcohol (>20 alcoholic consumptions per week) and drugs
- Smoking
- Plans to lose weight or following a hypocaloric diet;
Show all 15Show fewer
- Use of any medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing;
- Regular use of laxation products;
- Use of antibiotics in the 90 days prior to the start of study.
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- Known pregnancy, lactation (checked by a pregnancy test before start of study)
- Blood donation within 3 months before study period
- Prohibited use of pro-, pre- or synbiotics during study period and three months prior to start of study. A list with forbidden products will be provided (E4 PreProbiotics).
- Self-admitted HIV-positive state
- History of any side effects towards intake of pro- or prebiotic supplements of any kind
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
About this study
Official title: The Effects of Long-term Arabinoxylan Administration on Intestinal Barrier Function and Innate Immunity
The higher prevalence of overweight and obesity among the population contributes to increased incidences of chronic metabolic diseases. Obesity is considered a low-grade systemic inflammatory condition through 1) production of pro-inflammatory cytokines by adipose tissue and 2) alterations in intestinal microbiota composition and associated increase in intestinal permeability. Healthcare costs related to these diseases are rising; prevention or delay of onset of disorders associated with overweight is needed. Administration of wheat arabinoxylans (NAXUS), a non-digestible carbohydrate, may change the intestinal microbiota composition and have beneficial effects on gut epithelial barrier, especially on permeability and innate immune function.
Objective: To assess the effects of NAXUS on intestinal barrier function, immune system performance and metabolic control. Prebiotic properties of NAXUS will be studied. Tolerance of the product in different doses will also be investigated.
- Conditions
- Obesity, Overweight
- Being tested
- NAXUS, Placebo
- Keywords
- Prebiotics, Intestinal permeability, Gut barrier function, Immunity
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAXUSDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo |
| NAXUS 7.5 grams | Experimental | Arabinoxylan Receives: Dietary Supplement: NAXUS |
| NAXUS 15.0 grams | Experimental | Arabinoxylan Receives: Dietary Supplement: NAXUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to assess the change from baseline intestinal barrier function at 6 weeks, by performing a gut sugar permeability test.
Measured: Baseline and after 6 weeks of administration
Secondary outcomes (5)
To assess the change from baseline intestinal barrier function at 6 weeks, by assessing the tight junction structure and proteins in colonic biopsies.
Assessment will take place by immunofluorescent labelling and Polymerase Chain Reaction quantification of zonulin-1, claudin-3, occluding, myosin light chain kinase and phosphorylated myosin light chain.
Measured: Baseline and after 6 weeks of administration
To assess the change from baseline local and systemic immune system performance at 6 weeks.
Secondary outcome will be measured by the expression of immune parameters in colonic biopsies, by multiplex cytokine analysis in blood and Peripheral Blood Mononuclear Cell stimulation assays.
Measured: Baseline and after 6 weeks administration
To assess the change from baseline prebiotic properties at 3 and 6 weeks, by collecting faecal samples, intestinal contents and mucosal contents.
The microbial community composition, Short-chain Fatty Acid profiles in intestinal content and faeces and proteolytic activity markers in intestinal content and faeces will be determined.
Measured: Baseline, after 3 and after 6 weeks of administration
To assess the change from baseline glucose and lipid metabolism at 3 and 6 weeks
By determining glucose, insulin and triglyceride in blood samples. Cholesterol and free fatty acids will be measured as part of general blood profiling. Moreover effects on insulin sensitivity will be estimated by measuring HOMA-IR. Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations.
Measured: Baseline, after 3 and after 6 weeks of adminstration
To assess the effect of different doses of NAXUS administration on tolerance and digestive (dys)comfort.
Via questionnaires stool frequency, stool consistency and gastrointestinal symptoms will be measured.
Measured: At baseline, after 1 wk of administration, after 2 wks of administration, after 3 wks of administration, after 4 wks of administration, after 5 wks of administration, after 6 wks of administration (in total 7 times)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bouke Salden, Maastricht University Medical Center
- Investigators
- A.A.M. Masclee, Professor, Principal investigator, Department of Internal Medicine, Division of Gastroenterology-Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877044
- Sponsor's protocol ID
- 123050
- Status last verified
- Jul 2015
- First submitted
- 5 Jun 2013
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salden BN, Troost FJ, Wilms E, Truchado P, Vilchez-Vargas R, Pieper DH, Jauregui R, Marzorati M, van de Wiele T, Possemiers S, Masclee AA. Reinforcement of intestinal epithelial barrier by arabinoxylans in overweight and obese subjects: A randomized controlled trial: Arabinoxylans in gut barrier. Clin Nutr. 2018 Apr;37(2):471-480. doi: 10.1016/j.clnu.2017.01.024. Epub 2017 Feb 3.
PubMed 28214040
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Long-term Arabinoxylan Administration on Intestinal Barrier Function and Innate Immunity
- ClinicalTrials.gov ID
- NCT01877044
- Acronym / sponsor ID
- 123050
- Conditions
- Obesity, Overweight
- Keywords
- Prebiotics, Intestinal permeability, Gut barrier function, Immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Jun 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.
The higher prevalence of overweight and obesity among the population contributes to increased incidences of chronic metabolic diseases. Obesity is considered a low-grade systemic inflammatory condition through 1) production of pro-inflammatory cytokines by adipose tissue and 2) alterations in intestinal microbiota composition and associated increase in intestinal permeability. Healthcare costs related to these diseases are rising; prevention or delay of onset of disorders associated with overweight is needed. Administration of wheat arabinoxylans (NAXUS), a non-digestible carbohydrate, may change the intestinal microbiota composition and have beneficial effects on gut epithelial barrier, especially on permeability and innate immune function.
Objective: To assess the effects of NAXUS on intestinal barrier function, immune system performance and metabolic control. Prebiotic properties of NAXUS will be studied. Tolerance of the product in different doses will also be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin |
| NAXUS 7.5 grams | Experimental | Dietary Supplement: NAXUSArabinoxylan |
| NAXUS 15.0 grams | Experimental | Dietary Supplement: NAXUSArabinoxylan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Overweight men/women (BMI 28-35 kg/m2)
- Besides overweight, healthy human beings
- Fasting glucose <7.0 mmol/L
- Normal HbA1c (4.4 to 6.2%)
- Consistently stable body weight for at least 6 months (± 2 kg)
Key exclusion criteria (15 listed)
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L);
- Gastroenterological diseases or abdominal surgery;
- Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
- Abuse of products; alcohol (>20 alcoholic consumptions per week) and drugs
- Smoking
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 |
|---|---|---|
| NAXUS | Dietary supplement | NAXUS 15.0 grams, NAXUS 7.5 grams |
| Placebo | Dietary supplement | Placebo |
Primary outcome
The primary objective of this study is to assess the change from baseline intestinal barrier function at 6 weeks, by performing a gut sugar permeability test.
Time frame: Baseline and after 6 weeks of administration
5 secondary outcomes
To assess the change from baseline intestinal barrier function at 6 weeks, by assessing the tight junction structure and proteins in colonic biopsies.
Time frame: Baseline and after 6 weeks of administration
To assess the change from baseline local and systemic immune system performance at 6 weeks.
Time frame: Baseline and after 6 weeks administration
To assess the change from baseline prebiotic properties at 3 and 6 weeks, by collecting faecal samples, intestinal contents and mucosal contents.
Time frame: Baseline, after 3 and after 6 weeks of administration
To assess the change from baseline glucose and lipid metabolism at 3 and 6 weeks
Time frame: Baseline, after 3 and after 6 weeks of adminstration
To assess the effect of different doses of NAXUS administration on tolerance and digestive (dys)comfort.
Time frame: At baseline, after 1 wk of administration, after 2 wks of administration, after 3 wks of administration, after 4 wks of administration, after 5 wks of administration, after 6 wks of administration (in total 7 times)
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 Jul 2015.
- Derived from this study: PubMed 28214040Salden BN, Troost FJ, Wilms E, Truchado P, Vilchez-Vargas R, Pieper DH, Jauregui R, Marzorati M, van de Wiele T, Possemiers S, Masclee AA. Reinforcement of intestinal epithelial barrier by arabinoxylans in overweight and obese subjects: A randomized controlled trial: Arabinoxylans in gut barrier. Clin Nutr. 2018 Apr;37(2):471-480. doi: 10.1016/j.clnu.2017.01.024. Epub 2017 Feb 3.
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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.
A.A.M. Masclee, Professor principal investigator
Department of Internal Medicine, Division of Gastroenterology-Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAXUS in people with Obesity and Overweight, 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 15 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 Jul 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?
The primary objective of this study is to assess the change from baseline intestinal barrier function at 6 weeks, by performing a gut sugar permeability test. (time frame: Baseline and after 6 weeks of 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 NCT01877044, 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 8 Jul 2015.