Novel Alpha-Glucan Metabolism

Study Overview
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Brief Summary
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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
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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)

Official Title
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Randomised, Placebo-controlled and Acute Study to Investigate the Metabolism of a Novel Alpha-Glucan in Adults

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Drinkable solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 3X3
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: novel alpha glucan<br>50g novel alpha glucan dissolved in 300ml water | Dietary Supplement: Drinkable solution<br>* the volunteer will consume the volume 300 ml of water with<br>|
| Active Comparator: glucose syrup<br>50g dissolved in 300ml water | Dietary Supplement: Drinkable solution<br>* the volunteer will consume the volume 300 ml of water with<br>|
| Active Comparator: Inulin<br>15g Inulin dissolved in 300ml water | Dietary Supplement: Drinkable solution<br>* the volunteer will consume the volume 300 ml of water with<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose concentration post ingestion of a test product | postprandial glycemic response | 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin response post ingestion of a test product | postprandial insulin response | 180 minutes | 
| intestinal hydrogen production as measured by breath hydrogen | postprandial breath hydrogen | 240 minutes |