Digestive Tolerance in Healthy AdultsNCT01909323
Digestive Tolerance of Maltitol and FOS
A study testing maltitol 85% / FOS15%, maltitol alone and maltitol 68% / FOS 32% in people with Digestive Tolerance in Healthy Adults, run by Syral at 1 site in France.
Trial summary
Digestive symptoms following consumption of low digestibe carbohydrates are generally assessed product by product but several ingredients can be used simultaneously. The study aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive Tolerance in Healthy Adults
- What is being tested?
- maltitol 85% / FOS15%, maltitol alone and maltitol 68% / FOS 32%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Nov 2012
- 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
- BMI between 18.5 and 30
- normal and regular stool frequency: at least 3 stools per week and no more than 3 per days
- subjects not sufferinf from a metabolic, functional or inflammatory disease affecting intestinal transit and nutrients absorption
- subjects not sufferinf from IBS according to Rome III criteria
- subjects not using mdeiction which could affect nutrients absoprtion
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digestive Tolerance and Postprandial Glycaemic and Insulinaemic Responses Evaluation of Different Maltitol/FOS Mixtures in Healthy Adults
Digestive symptoms following consumption of low digestibe carbohydrates are generally assessed product by product but several ingredients can be used simultaneously. The study aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food.
- Conditions
- Digestive Tolerance in Healthy Adults
- Being tested
- maltitol 85% / FOS15%, maltitol alone, maltitol 68% / FOS 32%, maltitol 50% / FOS 50%, FOS alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maltitol 85% / FOS15%Other
maltitol aloneOther
maltitol 68% / FOS 32%Other
maltitol 50% / FOS 50%Other
FOS aloneOther
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| sugary dessert cream | Placebo comparator | Not described Receives: Other: Placebo |
| maltitol alone | Experimental | Not described Receives: Other: maltitol alone |
| maltitol 85% / FOS 15% | Experimental | Not described Receives: Other: maltitol 85% / FOS15% |
| maltitol 68% / FOS 32% | Experimental | Not described Receives: Other: maltitol 68% / FOS 32% |
| maltitol 50% / FOS 50% | Experimental | Not described Receives: Other: maltitol 50% / FOS 50% |
| FOS alone | Experimental | Not described Receives: Other: FOS alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score of gastrointestinal symptoms in the 24h following the consumption of products
Measured: 24 hours
Secondary outcomes (3)
Individual scores of gastrointestinal symptoms: bloating, abdominal discomfort, borborygms, flatulences
Measured: 24 and 48 hours
Stool frequcency and consistency
Measured: 24 & 48 hours
Glycaemic response
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive Tolerance in Healthy AdultsStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syral
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beghin-Meiji
- Responsible party
- Sponsor
- Investigators
- David Gendre, MD, Principal investigator, Biofortis SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909323
- Sponsor's protocol ID
- SMALTO
- Status last verified
- Jul 2013
- First submitted
- 24 Jul 2013
- Last updated
- 26 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digestive Tolerance and Postprandial Glycaemic and Insulinaemic Responses Evaluation of Different Maltitol/FOS Mixtures in Healthy Adults
- ClinicalTrials.gov ID
- NCT01909323
- Acronym / sponsor ID
- SMALTO
- Conditions
- Digestive Tolerance in Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SyralIndustry (pharma, biotech, devices)
- Collaborators
- Beghin-Meiji
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 26 Jul 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.
Digestive symptoms following consumption of low digestibe carbohydrates are generally assessed product by product but several ingredients can be used simultaneously. The study aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| sugary dessert cream | Placebo comparator | Other: Placebo |
| maltitol alone | Experimental | Other: maltitol alone |
| maltitol 85% / FOS 15% | Experimental | Other: maltitol 85% / FOS15% |
| maltitol 68% / FOS 32% | Experimental | Other: maltitol 68% / FOS 32% |
| maltitol 50% / FOS 50% | Experimental | Other: maltitol 50% / FOS 50% |
| FOS alone | Experimental | Other: FOS alone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI between 18.5 and 30
- normal and regular stool frequency: at least 3 stools per week and no more than 3 per days
- subjects not sufferinf from a metabolic, functional or inflammatory disease affecting intestinal transit and nutrients absorption
- subjects not sufferinf from IBS according to Rome III criteria
- subjects not using mdeiction which could affect nutrients absoprtion
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| maltitol 85% / FOS15% | Other | maltitol 85% / FOS 15% |
| maltitol alone | Other | maltitol alone |
| maltitol 68% / FOS 32% | Other | maltitol 68% / FOS 32% |
| maltitol 50% / FOS 50% | Other | maltitol 50% / FOS 50% |
| FOS alone | Other | FOS alone |
| Placebo | Other | sugary dessert cream |
Primary outcome
Composite score of gastrointestinal symptoms in the 24h following the consumption of products
Time frame: 24 hours
3 secondary outcomes
Individual scores of gastrointestinal symptoms: bloating, abdominal discomfort, borborygms, flatulences
Time frame: 24 and 48 hours
Stool frequcency and consistency
Time frame: 24 & 48 hours
Glycaemic response
Time frame: 2 hours
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 26 Jul 2013.
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.
David Gendre, MD principal investigator
Biofortis SAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maltitol 85% / FOS15%, maltitol alone and maltitol 68% / FOS 32% in people with Digestive Tolerance in Healthy Adults, run by Syral at 1 site in France.
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 1 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 26 Jul 2013. 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 France. 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?
Composite score of gastrointestinal symptoms in the 24h following the consumption of products (time frame: 24 hours). 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 26 Jul 2013.