Novel Alpha Glucan GI Tolerability Study (Loris Chronic)

Nestlé

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Drinkable solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT05142137

2025NR

Details and patient eligibility

About

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).

Full 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)

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Novel alpha glucan_dose1

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Drinkable solution

Novel alpha glucan_dose2

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Drinkable solution

glucose syrup

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: Drinkable solution