Evaluation of Dose-effect of a New Fermented Food in Healthy Adults
Status
Completed
Conditions
Healthy
Treatments
Other: Fermented dairy product
Other: milk-based non-fermented dairy product
Details and patient eligibility
About
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.
Enrollment
96 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
96 participants in 4 patient groups
1 = Test Product normal dose
Active Comparator group
Description:
Fermented dairy product containing probiotics - normal dose
Treatment:
Other: Fermented dairy product
2 = Test Product high dose
Active Comparator group
Description:
Fermented dairy product containing probiotics - high dose
Treatment:
Other: Fermented dairy product
3 = Control Product normal dose
Sham Comparator group
Description:
Non-fermented dairy product - normal dose
Treatment:
Other: milk-based non-fermented dairy product
4 = Control Product high dose
Sham Comparator group
Description:
Non-fermented dairy product - high dose
Treatment:
Other: milk-based non-fermented dairy product
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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