Effect of a Specific Blend of Fibers and Probiotics on the Microbiome

Nestlé

Status: Completed

Conditions: Microbiota Perturbation by an Environmental Challenge

Treatments: Dietary Supplement: Fibers and probiotics

Study type: Interventional

Funder types: Industry

Identifiers

NCT04424329

19.17.NRC

Details and patient eligibility

About

The study will investigate the effect of a mix of fibers and probiotics on faecal microbiota challenged by an environmental stress

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Informed consent signed
2. Adult men and women aged 18 to 45 years
3. Healthy based on the medical screening visit and medical questionnaire
4. BMI in the range of 18.5 to 29.9 kg/m2.

Exclusion criteria

1. Known food allergy and intolerance
2. Currently participating in another clinical trial or research project
3. Fewer than 5 spontaneous bowel movements per week on average
4. Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily
5. Systemic antibacterial/antifungal therapy during the 3 months prior to study enrolment
6. Medications or supplements that are known to alter gut function or microflora during the 4 weeks prior to study enrolment
7. Volunteers under anti-hyperlipidemic, antihypertensive, estrogen-related and/or anticoagulant agents
8. Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or herniotomy)
9. 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.
10. Artificially sweetened beverage intake higher than 1000 ml/ per day
11. Female subjects will be excluded if they are pregnant, gave birth in the last 6 months, or are lactating.
12. Subject having a hierarchical or family link with the research team members.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Nutrition intervention

Experimental group

Description:

Ingestion of fibers and probiotics daily for 22 days

Treatment:

Dietary Supplement: Fibers and probiotics

No intervention

No Intervention group

Description:

No intervention