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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014