Clinical trial NCT05142137: Novel Alpha Glucan GI Tolerability Study (Loris Chronic)
Official title: Randomised, Placebo-controlled Chronic Study to Investigate Gastrointestinal Tolerability of a Novel Alpha Glucan in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-12-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 3x3
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Throughout 7 days of treatment
Secondary outcomes:
measure: Stool consistency
timeFrame: Throughout 7 days of treatment
measure: Stool frequency
timeFrame: Throughout 7 days of treatment
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Clinical Innovation Lab
state: Vaud
Study officials:
References:
citation: 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.
citation: 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.