Novel Alpha Glucan GI Tolerability Study (Loris Chronic)

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05142137
• Other study ID #: 2025NR
• Status: Completed
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2021
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 31, 2021
• Est. primary completion date: October 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female participant,

2. Healthy status (based on anamnesis),

3. Age between 18 and 65 years,

4. Body mass index (BMI) between 18.5 and 29.9 kg/m2,

5. Able to understand and sign informed consent form,

6. Having a smartphone with Android or iOS version compatible with Patient Cloud application

Exclusion Criteria:

1. Fasting plasma glucose higher or equal to 6,1 mmol /L at screening,

2. Type I and type 2 diabetes,

3. Pregnant or lactating women,

4. Known food allergy or intolerance to test products,

5. 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,

6. Colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior the test,

7. Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time,

8. Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments,

9. 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,

10. Recent episode of an acute gastrointestinal illness,

11. Habitual consumption of more than four servings per day of high-fiber foods or extreme dietary habits (e.g. very low carbohydrate diet),

12. Ongoing or recent weight loss interventions (e.g. dietary weight loss programs),

13. 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,

14. Score of "severe" symptom for any of the symptoms included in the gastrointestinal symptom questionnaire,

15. Volunteer who cannot be expected to comply with the protocol,

16. Family or hierarchical relationships with Clinical Innovation Lab team.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Drinkable solution
The volunteers will consume 300 ml of liquid solution containing the novel alpha glucan or glucose syrup

Locations

Country	Name	City	State
Switzerland	Clinical Innovation Lab	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

References & 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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Throughout 7 days of treatment
Secondary	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.	Throughout 7 days of treatment