- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05058144
Novel Alpha-Glucan Metabolism
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lausanne, Switzerland
- Clinical Innovation Lab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: novel alpha glucan
50g novel alpha glucan dissolved in 300ml water
|
the volunteer will consume the volume 300 ml of water with
|
Active Comparator: glucose syrup
50g dissolved in 300ml water
|
the volunteer will consume the volume 300 ml of water with
|
Active Comparator: Inulin
15g Inulin dissolved in 300ml water
|
the volunteer will consume the volume 300 ml of water with
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose concentration post ingestion of a test product
Time Frame: 180 minutes
|
postprandial glycemic response
|
180 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
insulin response post ingestion of a test product
Time Frame: 180 minutes
|
postprandial insulin response
|
180 minutes
|
intestinal hydrogen production as measured by breath hydrogen
Time Frame: 240 minutes
|
postprandial breath hydrogen
|
240 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20.23.NR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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