Novel Alpha-Glucan Metabolism

NCT ID: NCT05058144

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2022-01-30

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)

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

novel alpha glucan

50g novel alpha glucan dissolved in 300ml water

Group Type: EXPERIMENTAL

Drinkable solution

Intervention Type: DIETARY_SUPPLEMENT

the volunteer will consume the volume 300 ml of water with

glucose syrup

50g dissolved in 300ml water

Group Type: ACTIVE_COMPARATOR

Drinkable solution

Intervention Type: DIETARY_SUPPLEMENT

the volunteer will consume the volume 300 ml of water with

Inulin

15g Inulin dissolved in 300ml water

Group Type: ACTIVE_COMPARATOR

Drinkable solution

Intervention Type: DIETARY_SUPPLEMENT

the volunteer will consume the volume 300 ml of water with

Interventions

Drinkable solution

the volunteer will consume the volume 300 ml of water with

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Innovation Lab

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

20.23.NR

Identifier Type: -

Identifier Source: org_study_id