Evaluation of Dose-effect of a New Fermented Food in Healthy Adults

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-06-30

Brief Summary

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The aim of the study is to assess the safety and tolerance of a new fermented food versus a control product in healthy adults during the 4-week consumption period.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 = Test Product normal dose

Fermented dairy product containing probiotics - normal dose

Group Type ACTIVE_COMPARATOR

Fermented dairy product

Intervention Type OTHER

2 = Test Product high dose

Fermented dairy product containing probiotics - high dose

Group Type ACTIVE_COMPARATOR

Fermented dairy product

Intervention Type OTHER

3 = Control Product normal dose

Non-fermented dairy product - normal dose

Group Type SHAM_COMPARATOR

milk-based non-fermented dairy product

Intervention Type OTHER

4 = Control Product high dose

Non-fermented dairy product - high dose

Group Type SHAM_COMPARATOR

milk-based non-fermented dairy product

Intervention Type OTHER

Interventions

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Fermented dairy product

Intervention Type OTHER

milk-based non-fermented dairy product

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects after receiving a full description of the study, provide written informed consent to take part in the study.
* 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 with any allergy (food, respiratory…).
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes