Clinical trial NCT01108419: Evaluation of Dose-effect of a New Fermented Food in Healthy Adults
Official title: Evaluation of the Safety and Tolerance of a New Fermented Food in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy adults
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2010-04-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effect of 1 bottle/day of test versus control product on adverse events.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product vital signs.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product vital signs.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product vital signs.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product vital signs.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product vital signs.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product on hematology.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product on hematology.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product on hematology.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product on glucose and lipids metabolism.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product on liver function.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product on kidney function.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product on thyroid function.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product on blood marker of inflammation.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product on fecal marker of inflammation.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product on bowel habits.
timeFrame: During the 4-week period of product consumption.
measure: Effect of 1 bottle/day of test versus control product on digestive symptoms.
timeFrame: During the 4-week period of product consumption.
Secondary outcomes:
measure: Effect of 1 bottle/day of test versus control product on adverse events.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product vital signs.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product vital signs.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product vital signs.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product vital signs.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product vital signs.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product on hematology.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product on hematology.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product on hematology.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product on glucose and lipids metabolism.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product on liver function.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product on kidney function.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product on thyroid function.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product on blood marker of inflammation.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product on fecal marker of inflammation.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product on bowel habits.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product on digestive symptoms.
timeFrame: During the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product on adverse events.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product vital signs.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product vital signs.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product vital signs.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product vital signs.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product vital signs.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product on hematology.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product on hematology.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product on hematology.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product on glucose and lipids metabolism.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product on liver function.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product on kidney function.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product on thyroid function.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product on blood marker of inflammation.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product on fecal marker of inflammation.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product on bowel habits.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 3 bottles/day of test versus control product on digestive symptoms.
timeFrame: During the 4-week period of product consumption, the 4-week follow-up period and the 8-week entire study period.
measure: Effect of 1 bottle/day of test versus control product on test product strains detection and quantification in feces.
timeFrame: During the 4-week period of product consumption and after 4-week follow-up period.
measure: Effect of 1 bottle/day of test versus control product on microbiota analysis in feces.
timeFrame: During the 4-week period of product consumption and after 4-week follow-up period.
measure: Effect of 1 bottle/day of test versus control product on microbiota analysis in feces.
timeFrame: During the 4-week period of product consumption and after 4-week follow-up period.
measure: Effect of 3 bottles/day of test versus control product on test product strains detection and quantification in feces.
timeFrame: During the 4-week period of product consumption and after 4-week follow-up period.
measure: Effect of 3 bottles/day of test versus control product on microbiota analysis in feces.
timeFrame: During the 4-week period of product consumption and after 4-week follow-up period.
measure: Effect of 3 bottles/day of test versus control product on microbiota analysis in feces.
timeFrame: During the 4-week period of product consumption and after 4-week follow-up period.
Other outcomes:
Locations:
city: München
country: Germany
facility: Harrison Clinical Research Clinical Unit, Hilblestrasse 54
Study officials:
References: