Novel Alpha Glucan GI Tolerability Study (Loris Chronic)

NCT05142137 | Completed

• 1 other identifier: 2025NR
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal Symptom Rating Scale (GSRS)

  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.

  Throughout 7 days of treatment

Secondary Outcomes (2)

• Stool consistency

  Throughout 7 days of treatment

• Stool frequency

  Throughout 7 days of treatment

Study Arms (3)

Novel alpha glucan_dose1

EXPERIMENTAL

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)

Dietary Supplement: Drinkable solution

Novel alpha glucan_dose2

EXPERIMENTAL

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)

Dietary Supplement: Drinkable solution

glucose syrup

ACTIVE COMPARATOR

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).

Dietary Supplement: Drinkable solution

Interventions

Drinkable solution DIETARY_SUPPLEMENT

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

Novel alpha glucan_dose1; Novel alpha glucan_dose2; glucose syrup

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participant,
• Healthy status (based on anamnesis),
• Age between 18 and 65 years,
• Body mass index (BMI) between 18.5 and 29.9 kg/m2,
• Able to understand and sign informed consent form,
• Having a smartphone with Android or iOS version compatible with Patient Cloud application

You may not qualify if:

• Fasting plasma glucose higher or equal to 6,1 mmol /L at screening,
• Type I and type 2 diabetes,
• Pregnant or lactating women,
• Known food allergy or intolerance to test products,
• 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,
• Colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior the test,
• Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time,
• 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,
• Recent episode of an acute gastrointestinal illness,
• Habitual consumption of more than four servings per day of high-fiber foods or extreme dietary habits (e.g. very low carbohydrate diet),
• Ongoing or recent weight loss interventions (e.g. dietary weight loss programs),
• 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,
• Score of "severe" symptom for any of the symptoms included in the gastrointestinal symptom questionnaire,
• Volunteer who cannot be expected to comply with the protocol,

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Clinical Innovation Lab

Lausanne, Canton of Vaud, 1000 Lausanne 26, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 19428713 BACKGROUND

• 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.

  PMID: 25332993 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3x3

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: December 2, 2021
• Study Start: August 16, 2021
• Primary Completion: October 11, 2021
• Study Completion: October 31, 2021
• Last Updated: May 15, 2025

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)