Novel Alpha Glucan GI Tolerability Study (Loris Chronic)

NCT ID: NCT05142137

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2021-10-31

Brief Summary

This study aims to evaluate the gastrointestinal tolerance of chronic consumption (7 days) of a novel alpha glucan compared to a rapidly available carbohydrate (glucose syrup).

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. novel alpha glucan (80 g/day)

2. novel alpha glucan (180 g/day)

3. glucose syrup (180 g/day)

Conditions

Healthy Volunteers

Study Design

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

Study Groups

Novel alpha glucan_dose1

Total of 180 g of the novel alpha glucan per day, consumed in 4 individual doses (i.e. 4x45 g, with each dose dissolved in 300 ml of water)

Group Type: EXPERIMENTAL

Drinkable solution

Intervention Type: DIETARY_SUPPLEMENT

The volunteers will consume 300 ml of liquid solution containing the novel alpha glucan or glucose syrup

Novel alpha glucan_dose2

Total of 80 g of the novel alpha glucan + 100 g glucose syrup per day, consumed in 4 individual doses (i.e. 4x45 g, with each dose dissolved in 300 ml of water)

Group Type: EXPERIMENTAL

Drinkable solution

Intervention Type: DIETARY_SUPPLEMENT

The volunteers will consume 300 ml of liquid solution containing the novel alpha glucan or glucose syrup

glucose syrup

Total of 180 g glucose syrup per day, consumed in 4 individual doses (i.e. 4x45 g, with each dose dissolved in 300 ml of water).

Group Type: ACTIVE_COMPARATOR

Drinkable solution

Intervention Type: DIETARY_SUPPLEMENT

The volunteers will consume 300 ml of liquid solution containing the novel alpha glucan or glucose syrup

Interventions

Drinkable solution

The volunteers will consume 300 ml of liquid solution containing the novel alpha glucan or glucose syrup

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Male or female participant,

2. Healthy status (based on anamnesis),

3. Age between 18 and 65 years,

4. Body mass index (BMI) between 18.5 and 29.9 kg/m2,

5. Able to understand and sign informed consent form,

6. Having a smartphone with Android or iOS version compatible with Patient Cloud application

Exclusion Criteria

1. Fasting plasma glucose higher or equal to 6,1 mmol /L at screening,

2. Type I and type 2 diabetes,

3. Pregnant or lactating women,

4. Known food allergy or intolerance to test products,

5. Treatment with anorectic drugs, glucose-lowering drugs, steroids, medications known to affect glucose metabolism and/or gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption,

6. Colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior the test,

7. Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time,

8. Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments,

9. 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,

10. Recent episode of an acute gastrointestinal illness,

11. Habitual consumption of more than four servings per day of high-fiber foods or extreme dietary habits (e.g. very low carbohydrate diet),

12. Ongoing or recent weight loss interventions (e.g. dietary weight loss programs),

13. 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,

14. Score of "severe" symptom for any of the symptoms included in the gastrointestinal symptom questionnaire,

15. Volunteer who cannot be expected to comply with the protocol,

16. Family or hierarchical relationships with Clinical Innovation Lab team.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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, Canton of Vaud, Switzerland

Countries

Switzerland

References

Kelly RM, Dijkhuizen L, Leemhuis H. Starch and alpha-glucan acting enzymes, modulating their properties by directed evolution. J Biotechnol. 2009 Mar 25;140(3-4):184-93. doi: 10.1016/j.jbiotec.2009.01.020. Epub 2009 Feb 7.

Reference Type: BACKGROUND

PMID: 19428713 (View on PubMed)

Synytsya A, Novak M. Structural analysis of glucans. Ann Transl Med. 2014 Feb;2(2):17. doi: 10.3978/j.issn.2305-5839.2014.02.07.

Reference Type: BACKGROUND

PMID: 25332993 (View on PubMed)

Other Identifiers

2025NR

Identifier Type: -

Identifier Source: org_study_id