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OpenTrials
Completed

NCT Number: NCT05058144

Novel Alpha-Glucan Metabolism

These are the characteristics of the project:

Monocentric:

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

Completed

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Innovation Lab

Lausanne, Switzerland

About this study

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

  • 50 g novel alpha glucan
  • 50 g (rapidly digestible control)
  • 15 g (dietary fiber)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Drinkable solution

Dietary Supplement

the volunteer will consume the volume 300 ml of water with

Primary outcomes

  1. Glucose concentration post ingestion of a test product

    Time frame: 180 minutes

    postprandial glycemic response

Secondary outcomes

  1. insulin response post ingestion of a test product

    Time frame: 180 minutes

    postprandial insulin response

  2. intestinal hydrogen production as measured by breath hydrogen

    Time frame: 240 minutes

    postprandial breath hydrogen

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 27, 2021
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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