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

This study has been completed.
Sponsor:
Information provided by:
Danone Research
ClinicalTrials.gov Identifier:
NCT01108419
First received: March 29, 2010
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Other: Fermented dairy product
Other: milk-based non-fermented dairy product

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Official Title: Evaluation of the Safety and Tolerance of a New Fermented Food in Healthy Adults

Further study details as provided by Danone Research:

Primary Outcome Measures:
  • Number of adverse events [ Designated as safety issue: Yes ]

Study Start Date: March 2010
Study Completion Date: June 2012
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 = Test Product normal dose Other: Fermented dairy product
Active Comparator: 2 = Test Product high dose Other: Fermented dairy product
Sham Comparator: 3 = Control Product normal dose Other: milk-based non-fermented dairy product
Sham Comparator: 4 = Control Product high dose Other: milk-based non-fermented dairy product

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108419

Locations
Germany
Harrison Clinical Research Clinical Unit, Hilblestrasse 54
München, Germany, D-80636
Sponsors and Collaborators
Danone Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01108419     History of Changes
Other Study ID Numbers: NU327
Study First Received: March 29, 2010
Last Updated: June 25, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Danone Research:
healthy adults

ClinicalTrials.gov processed this record on May 16, 2013