Novel Alpha-Glucan Metabolism

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05058144
• Other study ID #: 20.23.NR
• Status: Completed
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: October 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

These are the characteristics of the project:

Monocentric:

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 30, 2022
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Drinkable solution
the volunteer will consume the volume 300 ml of water with

Locations

Country	Name	City	State
Switzerland	Clinical Innovation Lab	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose concentration post ingestion of a test product	postprandial glycemic response	180 minutes
Secondary	insulin response post ingestion of a test product	postprandial insulin response	180 minutes
Secondary	intestinal hydrogen production as measured by breath hydrogen	postprandial breath hydrogen	240 minutes