Gastrointestinal Disorder, FunctionalOATGUTNCT03014141
Effect of Oat Bran on Bowel Function and Appetite
A study testing Oat bran (Oatwell 28) and Maltodextrin in people with Gastrointestinal Disorder, Functional, run by dsm-firmenich Switzerland AG.
Trial summary
The consumption of oat bran fiber also has a significant bulking effect in humans. However, besides fecal bulk, dietary fiber can promote gut health in other ways. Therefore, the purpose of this study is to investigate the effects of oat bran (rich in oat beta-glucan) supplementation on bowel function and appetite. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Disorder, Functional
- What is being tested?
- Oat bran (Oatwell 28) and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Mar 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female between the ages of 18-60 years
- Subject has a body mass index of ≥18.5 and ≤30 kg/m2 at screening visit.
- Subject is willing to stick to their normal habitual diet excluding the consumption of any unusual high energy-rich or fat-rich meals or prolonged fasting, etc. through the study period.
- Subject is willing to maintain their habitual physical activity patterns throughout the study period.
- Subject has been weight stable within the last 6 months.
- Subject has no health conditions that would prevent him or her from fulfilling the study requirements as judged by the investigator on the basis of medical history and routine laboratory test results.
- Low fiber consumer (≤14 g per day)
- Subject is willing to follow study procedures and dietary restrictions (ex: stick to habitual diet, refrain from consuming alcohol 24 hours prior to test days).
Who cannot join
- History of a gastrointestinal disorder
- Lactose intolerant
- High fiber consumer (≥15 g per day)
- Use of pre-and probiotics in the past 90 days
- High protein consumer (i.e. vegetarians or those who follow diets high in protein such as paleo)
- History of psychological illness or conditions that may interfere with subjects ability to understand study directions
Show all 17Show fewer
- Use of antibiotics or signs of active systemic infection in the last 6 months.
- Subjects who are on hypo/hypercaloric diet aiming for weight loss or weight gain
- History or presence of cancer in the prior 2 years (except for non-melanoma skin cancer).
- Currently pregnant, lactating or planning to be pregnant during the study period
- Regular use of dietary supplements (ex: fish oil, riboflavin, etc.), 90 days prior to study inclusion
- Exposure to any non-registered drug product within the last 30 days prior to screening visit
- History of or strong potential for alcohol or substance abuse (within 12 months of screening visit). Alcohol abuse is defined as >60g (men)/40g (women) pure alcohol per day (1.5 L/ 1 l beer resp. 0.75l/0.5l wine).
- Allergy or sensitivity to oat bran or any meals or snacks provided
- Current smoker or use of tobacco products in the past 90 days
- Concurrent or recent participation (30 days) in a dietary intervention trial
- Anything in the judgment of the investigator would interfere with the subject's ability to comply with the study (protocol), which might confound the interpretation of the study results, or put the subject at undue risk.
About this study
Official title: The Effect of Oat Bran on Bowel Function and Appetite. A Randomized, Double-blind, Placebo-controlled, Cross-over Intervention Study in Healthy Humans.
The consumption of oat bran fiber also has a significant bulking effect in humans. However, besides fecal bulk, dietary fiber can promote gut health in other ways. Therefore, the purpose of this study is to investigate the effects of oat bran (rich in oat beta-glucan) supplementation on bowel function and appetite.
Read the detailed description
The study is a randomized, double-blind, placebo-controlled crossover study it involves a total of 8 visits with a 14 day run-in period for total study duration of 84 days. A washout period of 2 weeks will occur in between the 2, 28 day treatment periods. The effects of an oat bran beverage for breakfast on bowel function will be tested after 2 week and 4 weeks of intake.
- Conditions
- Gastrointestinal Disorder, Functional
- Being tested
- Oat bran (Oatwell 28), Maltodextrin
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oat bran (Oatwell 28)Other
Also called Oat bran oat beta-glucan
11 g oat bran containing 3.1 gram oat beta-glucan
MaltodextrinOther
11 g of Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Oat bran (Oatwell 28) | Active comparator | A beverage containing 11 gram (3 gram of oat beta-glucan) of Oat bran (Oatwell 28) will be consumed before breakfast Receives: Other: Oat bran (Oatwell 28) |
| Maltodextrin | Placebo comparator | A beverage containing 11 gram of maltodextrin will be consumed before breakfast. Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole gut transit time
Whole gut transit time is the time required for the passage of 80% of radio-opaque markers (ROM) which are detected by x-ray in the fecal samples collected over the next 5 days after swallowing the ROM.
Measured: 4 weeks
Secondary outcomes (15)
Whole gut transit time
Whole gut transit time is the time required for the passage of 80% of radio-opaque markers (ROM) which are detected by x-ray in the fecal samples collected over the next 5 days after swallowing the ROM.
Measured: 2 weeks
Stool frequency
using a bowel movement diary
Measured: 2 weeks and 4 weeks
Fecal output
Fecal out is the weight of the fecal samples collected over the 5 days preceding the 2 week and 4 week time point
Measured: 2 weeks and 4 weeks
Percent fecal moisture
Fecal moisture is determined by freeze drying fecal samples and calculating the percent moisture in the fecal sample
Measured: 2 weeks and 4 weeks
Bristol Stool Score
using Bristol Stool Chart
Measured: 2 weeks and 4 weeks
Fecal pH
Measured: 2 weeks and 4 weeks
Subjective measures of bowel comfort
Gastrointestinal Quality of life questionnaires (GIQLI)
Measured: 2 weeks and 4 weeks
Gut microbiota
Using 16S ribosomal RNA sequencing techniques
Measured: 2 weeks and 4 weeks
Fecal short chain fatty acids
Using gas chromatography
Measured: 2 weeks and 4 weeks
Fecal total bile acids
Measured: 2 weeks and 4 weeks
Fecal enzymes
fecal beta-glucoronidase
Measured: 2 weeks and 4 weeks
Fecal ammonia
Measured: 2 weeks and 4 weeks
Intestinal gas production
using breath hydrogen production
Measured: 2 weeks and 4 weeks
Appetite
Appetite will be measured via visual analogue score (VAS)
Measured: 2 weeks and 4 weeks
Ad libitum energy intake
Ad libitum energy intake is measured by serving the subject an excess of food
Measured: 2 weeks 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 posted9 Jan 2017 (estimated)
- Study startJun 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
Why it stopped: Study supply issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Disorder, FunctionalStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Slavin, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014141
- Sponsor's protocol ID
- 2015-12-10-OAT
- Acronym
- OATGUT
- Status last verified
- Aug 2018
- First submitted
- 21 Dec 2016
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grabitske HA, Slavin JL. Low-digestible carbohydrates in practice. J Am Diet Assoc. 2008 Oct;108(10):1677-81. doi: 10.1016/j.jada.2008.07.010.
PubMed 18926133Stewart ML, Nikhanj SD, Timm DA, Thomas W, Slavin JL. Evaluation of the effect of four fibers on laxation, gastrointestinal tolerance and serum markers in healthy humans. Ann Nutr Metab. 2010;56(2):91-8. doi: 10.1159/000275962. Epub 2010 Jan 19.
PubMed 20090313Chen HL, Haack VS, Janecky CW, Vollendorf NW, Marlett JA. Mechanisms by which wheat bran and oat bran increase stool weight in humans. Am J Clin Nutr. 1998 Sep;68(3):711-9. doi: 10.1093/ajcn/68.3.711.
PubMed 9734752
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oat Bran on Bowel Function and Appetite. A Randomized, Double-blind, Placebo-controlled, Cross-over Intervention Study in Healthy Humans.
- ClinicalTrials.gov ID
- NCT03014141
- Acronym / sponsor ID
- OATGUT / 2015-12-10-OAT
- Conditions
- Gastrointestinal Disorder, Functional
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study supply issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 9 Jan 2017 (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 consumption of oat bran fiber also has a significant bulking effect in humans. However, besides fecal bulk, dietary fiber can promote gut health in other ways. Therefore, the purpose of this study is to investigate the effects of oat bran (rich in oat beta-glucan) supplementation on bowel function and appetite.
Detailed description
The study is a randomized, double-blind, placebo-controlled crossover study it involves a total of 8 visits with a 14 day run-in period for total study duration of 84 days. A washout period of 2 weeks will occur in between the 2, 28 day treatment periods. The effects of an oat bran beverage for breakfast on bowel function will be tested after 2 week and 4 weeks of intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oat bran (Oatwell 28) | Active comparator | Other: Oat bran (Oatwell 28)A beverage containing 11 gram (3 gram of oat beta-glucan) of Oat bran (Oatwell 28) will be consumed before breakfast |
| Maltodextrin | Placebo comparator | Other: MaltodextrinA beverage containing 11 gram of maltodextrin will be consumed before breakfast. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male or female between the ages of 18-60 years
- Subject has a body mass index of ≥18.5 and ≤30 kg/m2 at screening visit.
- Subject is willing to stick to their normal habitual diet excluding the consumption of any unusual high energy-rich or fat-rich meals or prolonged fasting, etc. through the study period.
- Subject is willing to maintain their habitual physical activity patterns throughout the study period.
- Subject has been weight stable within the last 6 months.
Key exclusion criteria (17 listed)
- History of a gastrointestinal disorder
- Lactose intolerant
- High fiber consumer (≥15 g per day)
- Use of pre-and probiotics in the past 90 days
- High protein consumer (i.e. vegetarians or those who follow diets high in protein such as paleo)
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 |
|---|---|---|
| Oat bran (Oatwell 28)Also: Oat bran oat beta-glucan11 g oat bran containing 3.1 gram oat beta-glucan | Other | Oat bran (Oatwell 28) |
| Maltodextrin11 g of Maltodextrin | Other | Maltodextrin |
Primary outcome
Whole gut transit time
Time frame: 4 weeks
Whole gut transit time is the time required for the passage of 80% of radio-opaque markers (ROM) which are detected by x-ray in the fecal samples collected over the next 5 days after swallowing the ROM.
15 secondary outcomes
Whole gut transit time
Time frame: 2 weeks
Stool frequency
Time frame: 2 weeks and 4 weeks
Fecal output
Time frame: 2 weeks and 4 weeks
Percent fecal moisture
Time frame: 2 weeks and 4 weeks
Bristol Stool Score
Time frame: 2 weeks and 4 weeks
Fecal pH
Time frame: 2 weeks and 4 weeks
Subjective measures of bowel comfort
Time frame: 2 weeks and 4 weeks
Gut microbiota
Time frame: 2 weeks and 4 weeks
Fecal short chain fatty acids
Time frame: 2 weeks and 4 weeks
Fecal total bile acids
Time frame: 2 weeks and 4 weeks
Fecal enzymes
Time frame: 2 weeks and 4 weeks
Fecal ammonia
Time frame: 2 weeks and 4 weeks
Intestinal gas production
Time frame: 2 weeks and 4 weeks
Appetite
Time frame: 2 weeks and 4 weeks
Ad libitum energy intake
Time frame: 2 weeks and 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Background: PubMed 18926133Grabitske HA, Slavin JL. Low-digestible carbohydrates in practice. J Am Diet Assoc. 2008 Oct;108(10):1677-81. doi: 10.1016/j.jada.2008.07.010.
- Background: PubMed 20090313Stewart ML, Nikhanj SD, Timm DA, Thomas W, Slavin JL. Evaluation of the effect of four fibers on laxation, gastrointestinal tolerance and serum markers in healthy humans. Ann Nutr Metab. 2010;56(2):91-8. doi: 10.1159/000275962. Epub 2010 Jan 19.
- Background: PubMed 9734752Chen HL, Haack VS, Janecky CW, Vollendorf NW, Marlett JA. Mechanisms by which wheat bran and oat bran increase stool weight in humans. Am J Clin Nutr. 1998 Sep;68(3):711-9. doi: 10.1093/ajcn/68.3.711.
- Individual participant dataSharing planned: No
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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.
Joanne Slavin, PhD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Oat bran (Oatwell 28) and Maltodextrin in people with Gastrointestinal Disorder, Functional, run by dsm-firmenich Switzerland AG.
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 17 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: withdrawn, as of the sponsor's last update on 13 Aug 2018. 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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: 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 NCT03014141, which also lists 3 linked publications.
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 13 Aug 2018.