Evaluation of Dose-effect of a New Fermented Food in Healthy Adults
NCT ID: NCT01108419
Last Updated: 2020-12-23
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
96 participants
INTERVENTIONAL
2010-03-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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1 = Test Product normal dose
Fermented dairy product containing probiotics - normal dose
Fermented dairy product
2 = Test Product high dose
Fermented dairy product containing probiotics - high dose
Fermented dairy product
3 = Control Product normal dose
Non-fermented dairy product - normal dose
milk-based non-fermented dairy product
4 = Control Product high dose
Non-fermented dairy product - high dose
milk-based non-fermented dairy product
Interventions
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Fermented dairy product
milk-based non-fermented dairy product
Eligibility Criteria
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Inclusion Criteria
* Free-living subject, as evaluated during the clinical examination.
* Male/female subjects aged between 18 to 55 years (bounds included).
* Subjects with a body mass index (BMI) between 18.5 ≤ BMI \< 30kg/m².
* Healthy subjects (as determined by a medical examination)
Exclusion Criteria
* Subjects that have had any surgery or intervention requiring general anaesthesia in the last 4 weeks.
* Subjects with a history of chronic metabolic or gastrointestinal disease with the exception of appendectomy.
* Subjects with chronic or iatrogenic immunodeficiency (e.g. Chemotherapy, HIV).
* Subjects presenting a severe evolutive or chronic pathology (e.g. cancer,tuberculosis, Crohn's disease, cirrhosis, multiple sclerosis, Type I diabetes…).
* Subject with eating disorders.
* Subjects with cardiac, respiratory (including asthma) or renal insufficiency, cardiomyopathy, valvulopathy and medical history of rheumatic fever.
* Subjects with special medicated diet (for obesity, anorexia, metabolic pathology…).
* For female subjects: pregnancy, breast-feeding or not willing to use/not using an acceptable method of contraception
* Subject, in the Investigator's opinion, should not be randomised.
18 Years
55 Years
ALL
Yes
Sponsors
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Danone Global Research & Innovation Center
INDUSTRY
Responsible Party
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Locations
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Harrison Clinical Research Clinical Unit, Hilblestrasse 54
München, , Germany
Countries
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Other Identifiers
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NU327
Identifier Type: -
Identifier Source: org_study_id