Randomised, Placebo-controlled Chronic Study to Investigate Gastrointestinal Tolerability of a Novel Alpha Glucan in Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Volunteers
- Sponsor
- Société des Produits Nestlé (SPN)
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Gastrointestinal Symptom Rating Scale (GSRS)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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)
Investigators
Eligibility Criteria
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,
Outcomes
Primary Outcomes
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
- Stool consistency(Throughout 7 days of treatment)
- Stool frequency(Throughout 7 days of treatment)