Effect of a Specific Blend of Fibers and Probiotics on the Microbiome
NCT ID: NCT04424329
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2020-06-02
2020-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Nutrition intervention
Ingestion of fibers and probiotics daily for 22 days
Fibers and probiotics
A blend of fibers and seven probiotics
No intervention
No intervention
No interventions assigned to this group
Interventions
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Fibers and probiotics
A blend of fibers and seven probiotics
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Sami Damak
Role: PRINCIPAL_INVESTIGATOR
Société des produits Nestlé
Locations
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Société des produits Nestlé/Metabolic Unit
Lausanne, , Switzerland
Countries
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Other Identifiers
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19.17.NRC
Identifier Type: -
Identifier Source: org_study_id