An interventional study of Drinkable solution in Healthy Volunteers, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Treatment
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).
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:
Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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.
Time frame: Throughout 7 days of treatment
Stool consistency
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.
Time frame: Throughout 7 days of treatment
Stool frequency
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.
Time frame: Throughout 7 days of treatment
Plan to share: No
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Société des Produits Nestlé (SPN)