Change of Transit or CirculationNCT02491125
The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism
A study testing soluble wheat bran fibre in people with Change of Transit or Circulation and Obesity, run by Maastricht University Medical Center.
Trial summary
The study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Change of Transit or Circulation, Obesity
- What is being tested?
- soluble wheat bran fibre
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight to obese men and women (BMI ≥ 25 kg/m2 <35 kg/m2)
- Aged 20-50 years
- Caucasian
- Normal fasting glucose (<6.1 mmol/L.)
- Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
- Weight stable in last 3 months (±2 kg)
- A low defecation frequency, <4 times/week and no constipation or underlying pathology, as determined by gastro-intestinal questionnaires).
- A slow whole gut transit (>35h)
Who cannot join
- Woman lactating, pregnant (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test) or (post)-menopausal
- Regular smokers
- People with intensive fitness training, eg. athletes (≥3 per week ≥ 1 hour training)
- Diabetes Mellitus (defined as FPG ≥ 7.0 mmol/l and or 2h PG ≥ 11.1 mmol/l)
- Gastro-intestinal diseases or abdominal surgery, cardiovascular diseases, cancer, liver or kidney malfunctioning (determined based on ALAT and creatinine levels, respectively) disease with a life expectation shorter than 5 years
- Following a hypocaloric diet
Show all 19Show fewer
- Gluten intolerance
- Regular use of laxation products, or use of antibiotics, probiotics or prebiotics 3 months prior to the start of the study
- More than 2 symptoms occurring over a period of 12 weeks in the preceding 12 months such as
- Straining in >1/4 defecations;
- Lumpy or hard stools in >1/4 defecations;
- Sensation of incomplete evacuation in >1/4 defecations;
- Sensation of anorectal obstruction/blockade in >1/4 defecations
- Manual maneuvers to facilitate >1/4 defecations (e.g., digital evacuation, support of the pelvic floor); and/or
- <3 defecations/week
- Current use of medication interfering with study intervention or interfering with study endpoints/hypotheses
- Not to be able to understand the study information
- Blood donation 2 months prior to the study and during the study
- Participation in other studies
About this study
Official title: Effect of Prebiotic Fibre on Intestinal Health and Functioning
The study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism.
Read the detailed description
A human dietary intervention study will be performed in overweight to obese subjects with a slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs. placebo on gut health, including gut microbiota composition, gastrointestinal transit time, metabolic health and quality of life.
- Conditions
- Change of Transit or Circulation, Obesity
- Being tested
- soluble wheat bran fibre, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soluble wheat bran fibreDietary supplement
12 weeks daily intake of 15g of soluble wheat bran fibre
PlaceboDietary supplement
Also called Maltodextrin
12 weeks daily intake of 15g of maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 12 weeks placebo maltodextrin 15g/day ( 5 g in beverage, to be consumed three times a day) Receives: Dietary Supplement: Placebo |
| soluble wheat bran fibre | Experimental | 12 weeks soluble wheat bran fibre 15g/day (5 g in beverage, to be consumed three times a day) Receives: Dietary Supplement: soluble wheat bran fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole gut transit time [hours]
Whole gut transit time as measured by radio-opaque marker method
Measured: measured at baseline at week 1 and directly after the 12 week supplementation
Secondary outcomes (11)
Gastric emptying [min]
Gastric emptying measured by isotope breath test
Measured: measured at baseline at week 1 and directly after the 12 week supplementation
Oro-cecal transit time [min]
Oro-cecal transit time measured by hydrogen breath test
Measured: measured at baseline at week 1 and directly after the 12 week supplementation
Defecation frequency (bowel movement per day)
Defecation frequency as measured via questionnaire
Measured: measured at baseline at week 1 and directly after the 12 week supplementation
Energy expenditure
Energy expenditure measured by indirect calorimetry
Measured: measured at baseline at week 1 and directly after the 12 week supplementation
Substrate oxidation
Fat and carbohydrate oxidation measured by indirect calorimetry
Measured: measured at baseline at week 1 and directly after the 12 week supplementation
Plasma inflammatory cytokines Interleukin-6,8 and 1 (pg/ml)
IL-6, IL8,IL-1 measured by enzyme linked immunosorbent assay
Measured: measured at baseline at week 1 and directly after the 12 week supplementation
Adipose tissue gene expression
Adipose tissue gene expression measured by quantitative real time polymerase chain reaction
Measured: measured at baseline at week 1 and directly after the 12 week supplementation
Gut permeability
Gut permeability as measured by multi sugar assay
Measured: measured at baseline at week 1 and directly after the 12 week supplementation
Microbiota composition
Microbiota composition as measured by illumina sequencing in feces
Measured: measured at baseline at week 1 and directly after the 12 week supplementation
Fecal Short chain fatty acid concentrations
Fecal Short chain fatty acid concentrations measured by ion exchange chromatography with conductivity detection
Measured: measured at baseline at week 1 and directly after the 12 week supplementation
Plasma short chain fatty acid concentrations
Plasma short chain fatty acid concentrations measured by liquid chromatography-mass spectrometry
Measured: measured at baseline at week 1 and directly after the 12 week supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
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 Change of Transit or CirculationStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT02491125
- Sponsor's protocol ID
- NL52300.068.15
- Status last verified
- Oct 2018
- First submitted
- 23 Mar 2015
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller M, Hermes GDA, Emanuel E C, Holst JJ, Zoetendal EG, Smidt H, Troost F, Schaap FG, Damink SO, Jocken JWE, Lenaerts K, Masclee AAM, Blaak EE. Effect of wheat bran derived prebiotic supplementation on gastrointestinal transit, gut microbiota, and metabolic health: a randomized controlled trial in healthy adults with a slow gut transit. Gut Microbes. 2020 Nov 9;12(1):1704141. doi: 10.1080/19490976.2019.1704141. Epub 2020 Jan 25.
PubMed 31983281
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prebiotic Fibre on Intestinal Health and Functioning
- ClinicalTrials.gov ID
- NCT02491125
- Acronym / sponsor ID
- NL52300.068.15
- Conditions
- Change of Transit or Circulation, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Jul 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.
The study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism.
Detailed description
A human dietary intervention study will be performed in overweight to obese subjects with a slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs. placebo on gut health, including gut microbiota composition, gastrointestinal transit time, metabolic health and quality of life.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo12 weeks placebo maltodextrin 15g/day ( 5 g in beverage, to be consumed three times a day) |
| soluble wheat bran fibre | Experimental | Dietary Supplement: soluble wheat bran fibre12 weeks soluble wheat bran fibre 15g/day (5 g in beverage, to be consumed three times a day) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Overweight to obese men and women (BMI ≥ 25 kg/m2 <35 kg/m2)
- Aged 20-50 years
- Caucasian
- Normal fasting glucose (<6.1 mmol/L.)
- Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
Key exclusion criteria (19 listed)
- Woman lactating, pregnant (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test) or (post)-menopausal
- Regular smokers
- People with intensive fitness training, eg. athletes (≥3 per week ≥ 1 hour training)
- Diabetes Mellitus (defined as FPG ≥ 7.0 mmol/l and or 2h PG ≥ 11.1 mmol/l)
- Gastro-intestinal diseases or abdominal surgery, cardiovascular diseases, cancer, liver or kidney malfunctioning (determined based on ALAT and creatinine levels, respectively) disease with a life expectation 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 |
|---|---|---|
| soluble wheat bran fibre12 weeks daily intake of 15g of soluble wheat bran fibre | Dietary supplement | soluble wheat bran fibre |
| PlaceboAlso: Maltodextrin12 weeks daily intake of 15g of maltodextrin | Dietary supplement | Placebo |
Primary outcome
Whole gut transit time [hours]
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Whole gut transit time as measured by radio-opaque marker method
11 secondary outcomes
Gastric emptying [min]
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Oro-cecal transit time [min]
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Defecation frequency (bowel movement per day)
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Energy expenditure
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Substrate oxidation
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Plasma inflammatory cytokines Interleukin-6,8 and 1 (pg/ml)
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Adipose tissue gene expression
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Gut permeability
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Microbiota composition
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Fecal Short chain fatty acid concentrations
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
Plasma short chain fatty acid concentrations
Time frame: measured at baseline at week 1 and directly after the 12 week supplementation
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 2019.
- Derived from this study: PubMed 31983281Muller M, Hermes GDA, Emanuel E C, Holst JJ, Zoetendal EG, Smidt H, Troost F, Schaap FG, Damink SO, Jocken JWE, Lenaerts K, Masclee AAM, Blaak EE. Effect of wheat bran derived prebiotic supplementation on gastrointestinal transit, gut microbiota, and metabolic health: a randomized controlled trial in healthy adults with a slow gut transit. Gut Microbes. 2020 Nov 9;12(1):1704141. doi: 10.1080/19490976.2019.1704141. Epub 2020 Jan 25.
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 soluble wheat bran fibre in people with Change of Transit or Circulation and Obesity, run by Maastricht University Medical Center.
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 19 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 2019. 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. 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?
Whole gut transit time [hours] (time frame: measured at baseline at week 1 and directly after the 12 week supplementation). 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 NCT02491125, 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 2019.