Last updated: April 24, 2024
Sponsor: Roquette Freres
Overall Status: Completed
Phase
N/A
Condition
N/ATreatment
NUTRIOSE®
GLUCIDEX® IT21 (Placebo)
Clinical Study ID
NCT05105425
2020-A03403-36
Ages 18-60 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male volunteer,
- Age between 18 and 60 years (limits included),
- BMI between 18.5 and 25 kg/m² (limits included),
- Having a high or a low usual fiber consumption,
- With a usual normal intestinal transit. According to stool questionnaire completedbetween V1 and V2, mean of the 7 days of completion, maximum 3 stools / day and 5stools/weeks minimum and with mean normal consistency (from type 3 to type 5 of theBSFS and with a tolerance of 1 to 3 stools in deviation /week) according to theinvestigator's opinion,
- Non-smoking or with tobacco consumption < 5 cigarettes / day and agreeing to keep hissmoking habits unchanged during the all duration of the study,
- Weight stable within ± 5% in the last three months;
- No significant change in food habits or in physical activity in the 3 months beforethe study and agreeing to keep these habits unchanged throughout the study;
- Good general and mental health with in the opinion of the investigator: no clinicallysignificant and relevant abnormalities of medical history or physical examination,
- Able and willing to participate to the study by complying with the protocol proceduresas evidenced by his dated and signed informed consent form,
- Affiliated with a social security scheme
- Agreeing to be registered on the national file of volunteers in biomedical researchfile.
Exclusion
Exclusion Criteria:
- Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal troubleor other metabolic disorder,
- Suffering from gastrointestinal disorders such as celiac disease, Crohn's disease,functional constipation, irritable bowel syndrome or another gastrointestinal found tobe inconsistent with the study according to the investigator,
- Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic orbiliary disorders ongoing, uncontrolled cardiac disease, chronic inflammatorydigestive disease, arthritis or other chronic respiratory trouble, etc.) or anothersevere disorders found to be inconsistent with the conduct of the study by theinvestigator,
- With a known or suspected food allergy or intolerance or hypersensitivity to any ofthe study products' ingredient,
- Lactose intolerant,
- Having undergone recent surgical procedure in the past 6 months or planned in the 2months to come,
- Under treatment which could significantly affect parameter(s) followed during thestudy according to the investigator or stopped less than 4 weeks before the V1 visit,i.e. medication with impact on intestinal transit such as anti-diarrheal,anti-spasmodic, antidepressants antibiotics, antacids, laxative, antifungal, NSAI,antivomiting, corticoids, opioids, narcotic analgesic and biliary acids chelator, andchronic hormonal treatment started less than 3 months ago (i.e. new method of hormonalcontraception, thyroidal trouble treatment)
- Regular intake of dietary supplements or "health foods", or products known to impactintestinal microbiota, containing or rich in prebiotic, probiotic, synbiotics, fiber,fermented milk or yogurt, kefir, ultra-yeast, vitamins and minerals or stopped lessthan 3 months before the inclusion visit (V1);
- With a current or planned in the next 3 months specific diet (hyper or hypocaloric,vegan, vegetarian…) or stopped less than 3 months before the study,
- With a personal history of anorexia nervosa, bulimia or significant eating disordersaccording to the investigator,
- Consuming more than 3 standard drinks of alcoholic beverage or not agreeing to keephis alcohol consumption habits unchanged throughout the study,
- Having a lifestyle deemed incompatible with the study according to the investigatorincluding high level physical activity (defined as more than 10 hours of significantphysical activity a week, walking excluded),
- Taking part in another clinical trial or being in the exclusion period of a previousclinical trial,
- Having received, during the last 12 months, indemnities for clinical trial higher orequal to 4500 Euros,
- Under legal protection (guardianship, wardship) or deprived from his rights followingadministrative or judicial decision,
- Presenting a psychological or linguistic incapability to sign the informed consent,
- Impossible to contact in case of emergency.
Study Design
Total Participants: 124
Treatment Group(s): 2
Primary Treatment: NUTRIOSE®
Phase:
Study Start date:
July 19, 2021
Estimated Completion Date:
August 07, 2023
Connect with a study center
Clinical Investigation Unit of Biofortis Paris
Paris, 75012
FranceSite Not Available
Clinical Investigation Unit of Biofortis
Saint-Herblain, 44800
FranceSite Not Available
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