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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05058144
Other study ID # 20.23.NR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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