Novel Alpha-Glucan Metabolism

NCT05058144 | Completed

• 1 other identifier: 20.23.NR
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Glucose concentration post ingestion of a test product

  postprandial glycemic response

  180 minutes

Secondary Outcomes (2)

• insulin response post ingestion of a test product

  180 minutes

• intestinal hydrogen production as measured by breath hydrogen

  240 minutes

Study Arms (3)

novel alpha glucan

EXPERIMENTAL

50g novel alpha glucan dissolved in 300ml water

Dietary Supplement: Drinkable solution

glucose syrup

ACTIVE COMPARATOR

50g dissolved in 300ml water

Dietary Supplement: Drinkable solution

Inulin

ACTIVE COMPARATOR

15g Inulin dissolved in 300ml water

Dietary Supplement: Drinkable solution

Interventions

Drinkable solution DIETARY_SUPPLEMENT

the volunteer will consume the volume 300 ml of water with

Inulin; glucose syrup; novel alpha glucan

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or lactating women
• Type I and type 2 diabetes
• Known food allergy or intolerance to test product
• Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments
• 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
• 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
• Recent episode of an acute gastrointestinal illness
• 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.
• Smokers
• Volunteer who cannot be expected to comply with the protocol
• Family or hierarchical relationships with Clinical Innovation Lab team

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Clinical Innovation Lab

Lausanne, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3X3

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: September 27, 2021
• Study Start: August 30, 2021
• Primary Completion: November 3, 2021
• Study Completion: January 30, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)