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

This study has been completed.
Information provided by (Responsible Party):
Danone Research Identifier:
First received: March 29, 2010
Last updated: January 5, 2017
Last verified: January 2017
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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 [ Time Frame: 4 weeks of consumption ]

Enrollment: 96
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
Fermented dairy product containing probiotics - normal dose
Other: Fermented dairy product
Active Comparator: 2 = Test Product high dose
Fermented dairy product containing probiotics - high dose
Other: Fermented dairy product
Sham Comparator: 3 = Control Product normal dose
Non-fermented dairy product - normal dose
Other: milk-based non-fermented dairy product
Sham Comparator: 4 = Control Product high dose
Non-fermented dairy product - high dose
Other: milk-based non-fermented dairy product


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01108419

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

Responsible Party: Danone Research Identifier: NCT01108419     History of Changes
Other Study ID Numbers: NU327
Study First Received: March 29, 2010
Last Updated: January 5, 2017

Keywords provided by Danone Research:
healthy adults processed this record on August 17, 2017