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Completed

NCT Number: NCT05142137

Novel Alpha Glucan GI Tolerability Study (Loris Chronic)

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).

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Innovation Lab

Lausanne, Canton of Vaud, 1000 Lausanne 26, Switzerland

About this study

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:

  • novel alpha glucan (80 g/day)
  • novel alpha glucan (180 g/day)
  • glucose syrup (180 g/day)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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,
  • Family or hierarchical relationships with Clinical Innovation Lab team.

Treatment and study plan

Drinkable solution

Dietary Supplement

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

Primary outcomes

  1. Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: 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 outcomes

  1. Stool consistency

    Time frame: 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.

  2. Stool frequency

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Randomised, Placebo-controlled Chronic Study to Investigate Gastrointestinal Tolerability of a Novel Alpha Glucan in Adults

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2021
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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