Novel Alpha Glucan GI Tolerability Study (Loris Chronic)
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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:
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novel alpha glucan (80 g/day)
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novel alpha glucan (180 g/day)
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glucose syrup (180 g/day)
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Novel alpha glucan_dose1 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
The volunteers will consume 300 ml of liquid solution containing the novel alpha glucan or glucose syrup
|
Experimental: Novel alpha glucan_dose2 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
The volunteers will consume 300 ml of liquid solution containing the novel alpha glucan or glucose syrup
|
Active Comparator: glucose syrup 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
The volunteers will consume 300 ml of liquid solution containing the novel alpha glucan or glucose syrup
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female participant,
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Healthy status (based on anamnesis),
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Age between 18 and 65 years,
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Body mass index (BMI) between 18.5 and 29.9 kg/m2,
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Able to understand and sign informed consent form,
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Having a smartphone with Android or iOS version compatible with Patient Cloud application
Exclusion Criteria:
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Fasting plasma glucose higher or equal to 6,1 mmol /L at screening,
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Type I and type 2 diabetes,
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Pregnant or lactating women,
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Known food allergy or intolerance to test products,
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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,
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Colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior the test,
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Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time,
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Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments,
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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,
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Recent episode of an acute gastrointestinal illness,
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Habitual consumption of more than four servings per day of high-fiber foods or extreme dietary habits (e.g. very low carbohydrate diet),
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Ongoing or recent weight loss interventions (e.g. dietary weight loss programs),
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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,
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Score of "severe" symptom for any of the symptoms included in the gastrointestinal symptom questionnaire,
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Volunteer who cannot be expected to comply with the protocol,
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Family or hierarchical relationships with Clinical Innovation Lab team.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Clinical Innovation Lab | Lausanne | Vaud | Switzerland | 1000 Lausanne 26 |
Sponsors and Collaborators
- Nestlé
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2025NR