Healthy Volunteers
Conditions
Brief summary
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 1. 50 g novel alpha glucan 2. 50 g (rapidly digestible control) 3. 15 g (dietary fiber)
Interventions
DIETARY_SUPPLEMENTDrinkable solution
the volunteer will consume the volume 300 ml of water with
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
3X3
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
1. Pregnant or lactating women 2. Type I and type 2 diabetes 3. Known food allergy or intolerance to test product 4. Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments 5. 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 6. 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 7. Recent episode of an acute gastrointestinal illness 8. 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. 9. Smokers 10. Volunteer who cannot be expected to comply with the protocol 11. Family or hierarchical relationships with Clinical Innovation Lab team
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose concentration post ingestion of a test product | 180 minutes | postprandial glycemic response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| insulin response post ingestion of a test product | 180 minutes | postprandial insulin response |
| intestinal hydrogen production as measured by breath hydrogen | 240 minutes | postprandial breath hydrogen |
Countries
Switzerland
Outcome results
None listed