Healthy VolunteersNCT05142137
Novel Alpha Glucan GI Tolerability Study (Loris Chronic)
A study testing Drinkable solution in people with Healthy Volunteers, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
This study aims to evaluate the gastrointestinal tolerance of chronic consumption (7 days) of a novel alpha glucan compared to a rapidly available carbohydrate (glucose syrup). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Drinkable solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Aug 2021to 31 Oct 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participant,
- Healthy status (based on anamnesis),
- Age between 18 and 65 years,
- Body mass index (BMI) between 18.5 and 29.9 kg/m2,
- Able to understand and sign informed consent form,
- Having a smartphone with Android or iOS version compatible with Patient Cloud application
Who cannot join
- Fasting plasma glucose higher or equal to 6,1 mmol /L at screening,
- Type I and type 2 diabetes,
- Pregnant or lactating women,
- Known food allergy or intolerance to test products,
- Treatment with anorectic drugs, glucose-lowering drugs, steroids, medications known to affect glucose metabolism and/or gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption,
- Colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior the test,
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- Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time,
- Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments,
- Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily,
- Recent episode of an acute gastrointestinal illness,
- Habitual consumption of more than four servings per day of high-fiber foods or extreme dietary habits (e.g. very low carbohydrate diet),
- Ongoing or recent weight loss interventions (e.g. dietary weight loss programs),
- Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer,
- Score of "severe" symptom for any of the symptoms included in the gastrointestinal symptom questionnaire,
- Volunteer who cannot be expected to comply with the protocol,
- Family or hierarchical relationships with Clinical Innovation Lab team.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Innovation Lab
Lausanne, Canton of Vaud, 1000 Lausanne 26
About this study
Official title: Randomised, Placebo-controlled Chronic Study to Investigate Gastrointestinal Tolerability of a Novel Alpha Glucan in Adults
This study aims to evaluate the gastrointestinal tolerance of chronic consumption (7 days) of a novel alpha glucan compared to a rapidly available carbohydrate (glucose syrup).
Read the detailed description
This study will be randomized, double blind, placebo-controlled, single-center, and 3x3 crossover in design.
Eligible participants will be randomized to receive the below products in single dose and in different random sequence, as determined by the randomization system:
- novel alpha glucan (80 g/day)
- novel alpha glucan (180 g/day)
- glucose syrup (180 g/day)
- Conditions
- Healthy Volunteers
- Being tested
- Drinkable solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drinkable solutionDietary supplement
The volunteers will consume 300 ml of liquid solution containing the novel alpha glucan or glucose syrup
| Study group | Role | What they receive |
|---|---|---|
| Novel alpha glucan_dose1 | Experimental | Total of 180 g of the novel alpha glucan per day, consumed in 4 individual doses (i.e. 4x45 g, with each dose dissolved in 300 ml of water) Receives: Dietary Supplement: Drinkable solution |
| Novel alpha glucan_dose2 | Experimental | Total of 80 g of the novel alpha glucan + 100 g glucose syrup per day, consumed in 4 individual doses (i.e. 4x45 g, with each dose dissolved in 300 ml of water) Receives: Dietary Supplement: Drinkable solution |
| glucose syrup | Active comparator | Total of 180 g glucose syrup per day, consumed in 4 individual doses (i.e. 4x45 g, with each dose dissolved in 300 ml of water). Receives: Dietary Supplement: Drinkable solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Rating Scale (GSRS)
Validated questionnaire exploring the presence and severity of GI symptoms over the previous 7 days. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting reflux, abdominal pain, indigestion, diarrhea and constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The effect of the interventions on the GSRS will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment.
Measured: Throughout 7 days of treatment
Secondary outcomes (2)
Stool consistency
The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools, whereas 5 indicate lack of dietary fiber, and 6 and 7 indicate diarrhoea. The effect of the interventions on stool consistency will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment.
Measured: Throughout 7 days of treatment
Stool frequency
The participants report the number of defecations they have per day, throughout the 7 days study period. There is a large variability in this, but typically 1-3 defecations per day is considered normal, whereas more indicate a runny stool, and fewer a tendency for constipation. The effect of the interventions on stool frequency will be assessed by changes in stool frequency over time, taking all information on this from all 7 days of treatment into account.
Measured: Throughout 7 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start16 Aug 2021
- Primary completion11 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 3x3
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142137
- Sponsor's protocol ID
- 2025NR
- Status last verified
- Nov 2021
- First submitted
- 2 Sep 2021
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kelly RM, Dijkhuizen L, Leemhuis H. Starch and alpha-glucan acting enzymes, modulating their properties by directed evolution. J Biotechnol. 2009 Mar 25;140(3-4):184-93. doi: 10.1016/j.jbiotec.2009.01.020. Epub 2009 Feb 7.
PubMed 19428713Synytsya A, Novak M. Structural analysis of glucans. Ann Transl Med. 2014 Feb;2(2):17. doi: 10.3978/j.issn.2305-5839.2014.02.07.
PubMed 25332993
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Placebo-controlled Chronic Study to Investigate Gastrointestinal Tolerability of a Novel Alpha Glucan in Adults
- ClinicalTrials.gov ID
- NCT05142137
- Acronym / sponsor ID
- 2025NR
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 2 Dec 2021 (actual)
- 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.
This study aims to evaluate the gastrointestinal tolerance of chronic consumption (7 days) of a novel alpha glucan compared to a rapidly available carbohydrate (glucose syrup).
Detailed description
This study will be randomized, double blind, placebo-controlled, single-center, and 3x3 crossover in design.
Eligible participants will be randomized to receive the below products in single dose and in different random sequence, as determined by the randomization system:
- novel alpha glucan (80 g/day)
- novel alpha glucan (180 g/day)
- glucose syrup (180 g/day)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 3x3
| Arm | Type | Receives |
|---|---|---|
| Novel alpha glucan_dose1 | Experimental | Dietary Supplement: Drinkable solutionTotal of 180 g of the novel alpha glucan per day, consumed in 4 individual doses (i.e. 4x45 g, with each dose dissolved in 300 ml of water) |
| Novel alpha glucan_dose2 | Experimental | Dietary Supplement: Drinkable solutionTotal of 80 g of the novel alpha glucan + 100 g glucose syrup per day, consumed in 4 individual doses (i.e. 4x45 g, with each dose dissolved in 300 ml of water) |
| glucose syrup | Active comparator | Dietary Supplement: Drinkable solutionTotal of 180 g glucose syrup per day, consumed in 4 individual doses (i.e. 4x45 g, with each dose dissolved in 300 ml of water). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participant,
- Healthy status (based on anamnesis),
- Age between 18 and 65 years,
- Body mass index (BMI) between 18.5 and 29.9 kg/m2,
- Able to understand and sign informed consent form,
Key exclusion criteria (16 listed)
- Fasting plasma glucose higher or equal to 6,1 mmol /L at screening,
- Type I and type 2 diabetes,
- Pregnant or lactating women,
- Known food allergy or intolerance to test products,
- Treatment with anorectic drugs, glucose-lowering drugs, steroids, medications known to affect glucose metabolism and/or gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption,
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 |
|---|---|---|
| Drinkable solutionThe volunteers will consume 300 ml of liquid solution containing the novel alpha glucan or glucose syrup | Dietary supplement | Novel alpha glucan_dose1, Novel alpha glucan_dose2, glucose syrup |
Primary outcome
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Throughout 7 days of treatment
Validated questionnaire exploring the presence and severity of GI symptoms over the previous 7 days. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting reflux, abdominal pain, indigestion, diarrhea and constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The effect of the interventions on the GSRS will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment.
2 secondary outcomes
Stool consistency
Time frame: Throughout 7 days of treatment
Stool frequency
Time frame: Throughout 7 days of treatment
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 15 May 2025.
- Results publication: PubMed 19428713Kelly RM, Dijkhuizen L, Leemhuis H. Starch and alpha-glucan acting enzymes, modulating their properties by directed evolution. J Biotechnol. 2009 Mar 25;140(3-4):184-93. doi: 10.1016/j.jbiotec.2009.01.020. Epub 2009 Feb 7.
- Results publication: PubMed 25332993Synytsya A, Novak M. Structural analysis of glucans. Ann Transl Med. 2014 Feb;2(2):17. doi: 10.3978/j.issn.2305-5839.2014.02.07.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drinkable solution in people with Healthy Volunteers, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 6 inclusion and 16 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 15 May 2025. 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 Switzerland. 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. 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?
Gastrointestinal Symptom Rating Scale (GSRS) (time frame: Throughout 7 days of treatment). 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 NCT05142137, which also lists 2 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 15 May 2025.