Novel Alpha Glucan GI Tolerability Study (Loris Chronic)

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: Drinkable solution

• Registration Number: NCT05142137
• Lead Sponsor: Société des Produits Nestlé (SPN)

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)

Study Timeline

• Study Start: 2021-08-16
• Study First Submitted: 2021-09-02
• Primary Completion: 2021-10-11
• Study Completion: 2021-10-31
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-18
• Study First Posted: 2021-12-02
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Novel alpha glucan_dose2	Drinkable solution	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)
glucose syrup	Drinkable solution	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).
Novel alpha glucan_dose1	Drinkable solution	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)

Primary Outcome Measures

Name	Time	Method
Gastrointestinal Symptom Rating Scale (GSRS)	Throughout 7 days of treatment	Validated questionnaire exploring the presence and severity of GI symptoms over the previous 7 days. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting reflux, abdominal pain, indigestion, diarrhea and constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The effect of the interventions on the GSRS will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment.

Secondary Outcome Measures

Name	Time	Method
Stool consistency	Throughout 7 days of treatment	The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools, whereas 5 indicate lack of dietary fiber, and 6 and 7 indicate diarrhoea. The effect of the interventions on stool consistency will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment.
Stool frequency	Throughout 7 days of treatment	The participants report the number of defecations they have per day, throughout the 7 days study period. There is a large variability in this, but typically 1-3 defecations per day is considered normal, whereas more indicate a runny stool, and fewer a tendency for constipation. The effect of the interventions on stool frequency will be assessed by changes in stool frequency over time, taking all information on this from all 7 days of treatment into account.

Trial Locations

Locations (1)

Clinical Innovation Lab; 🇨🇭 Lausanne, Vaud, Switzerland