Novel Alpha-Glucan Metabolism

Nestlé

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Drinkable solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT05058144

20.23.NR

Details and patient eligibility

About

These are the characteristics of the project:

Monocentric:

Double blind randomized and crossover: you will test all the 3 products in random order.

Full 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)

Enrollment: 15 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 3 patient groups

novel alpha glucan

Experimental group

Description:

50g novel alpha glucan dissolved in 300ml water

Treatment:

Dietary Supplement: Drinkable solution

glucose syrup

Active Comparator group

Description:

50g dissolved in 300ml water

Treatment:

Dietary Supplement: Drinkable solution

Inulin

Active Comparator group

Description:

15g Inulin dissolved in 300ml water

Treatment:

Dietary Supplement: Drinkable solution