Healthy VolunteersNCT05058144
Novel Alpha-Glucan Metabolism
A study testing Drinkable solution in people with Healthy Volunteers, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
These are the characteristics of the project: Monocentric: Double blind randomized and crossover: you will test all the 3 products in random order. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Drinkable solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Aug 2021to 30 Jan 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy status (based on anamnesis) Body mass index (BMI) between 18.5 and 29.9 kg/m2 Able to understand and sign informed consent form.
Who cannot join
- Pregnant or lactating women
- Type I and type 2 diabetes
- Known food allergy or intolerance to test product
- 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
- Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior the test
Show all 11Show fewer
- Recent episode of an acute gastrointestinal illness
- 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.
- Smokers
- 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.
About this study
Official title: Randomised, Placebo-controlled and Acute Study to Investigate the Metabolism of a Novel Alpha-Glucan in Adults
These are the characteristics of the project:
Monocentric:
Double blind randomized and crossover: you will test all the 3 products in random order.
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
- 50 g novel alpha glucan
- 50 g (rapidly digestible control)
- 15 g (dietary fiber)
- 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 volunteer will consume the volume 300 ml of water with
| Study group | Role | What they receive |
|---|---|---|
| novel alpha glucan | Experimental | 50g novel alpha glucan dissolved in 300ml water Receives: Dietary Supplement: Drinkable solution |
| glucose syrup | Active comparator | 50g dissolved in 300ml water Receives: Dietary Supplement: Drinkable solution |
| Inulin | Active comparator | 15g Inulin dissolved in 300ml water Receives: Dietary Supplement: Drinkable solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose concentration post ingestion of a test product
postprandial glycemic response
Measured: 180 minutes
Secondary outcomes (2)
insulin response post ingestion of a test product
postprandial insulin response
Measured: 180 minutes
intestinal hydrogen production as measured by breath hydrogen
postprandial breath hydrogen
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start30 Aug 2021
- Primary completion3 Nov 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 3X3
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 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
- NCT05058144
- Sponsor's protocol ID
- 20.23.NR
- Status last verified
- Oct 2022
- First submitted
- 24 Jun 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Placebo-controlled and Acute Study to Investigate the Metabolism of a Novel Alpha-Glucan in Adults
- ClinicalTrials.gov ID
- NCT05058144
- Acronym / sponsor ID
- 20.23.NR
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 27 Sep 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.
These are the characteristics of the project:
Monocentric:
Double blind randomized and crossover: you will test all the 3 products in random order.
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
- 50 g novel alpha glucan
- 50 g (rapidly digestible control)
- 15 g (dietary fiber)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 3X3
| Arm | Type | Receives |
|---|---|---|
| novel alpha glucan | Experimental | Dietary Supplement: Drinkable solution50g novel alpha glucan dissolved in 300ml water |
| glucose syrup | Active comparator | Dietary Supplement: Drinkable solution50g dissolved in 300ml water |
| Inulin | Active comparator | Dietary Supplement: Drinkable solution15g Inulin dissolved in 300ml water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy status (based on anamnesis) Body mass index (BMI) between 18.5 and 29.9 kg/m2 Able to understand and sign informed consent form.
Key exclusion criteria (11 listed)
- Pregnant or lactating women
- Type I and type 2 diabetes
- Known food allergy or intolerance to test product
- 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
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 volunteer will consume the volume 300 ml of water with | Dietary supplement | Inulin, glucose syrup, novel alpha glucan |
Primary outcome
Glucose concentration post ingestion of a test product
Time frame: 180 minutes
postprandial glycemic response
2 secondary outcomes
insulin response post ingestion of a test product
Time frame: 180 minutes
intestinal hydrogen production as measured by breath hydrogen
Time frame: 240 minutes
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 14 Oct 2022.
- 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 1 inclusion and 11 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 14 Oct 2022. 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?
Glucose concentration post ingestion of a test product (time frame: 180 minutes). 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 14 Oct 2022.