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Effect of Consumption of Dairy Product on Upper Gastric Discomfort

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01422980
First Posted: August 25, 2011
Last Update Posted: October 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Danone Research
  Purpose
The purpose of this study is to determine whether the consumption of test dairy products is effective in reducing upper gastric discomfort after 2 weeks of product consumption.

Condition Intervention
Upper Gastric Discomfort Other: 1- Test dairy product containing specific ingredients Other: 2- Control dairy product without specific ingredients

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Consumption of Dairy Product on Upper Gastric Discomfort

Further study details as provided by Danone Research:

Primary Outcome Measures:
  • Change in gastro-oesophageal symptoms as assessed by RDQ questionnaire [ Time Frame: Two timepoints are considered in the assessment of the change outcome measures: from Baseline (before product consumption) to Endpoint (i.e. final evaluation visit after 2 weeks of product consumption) ]

Enrollment: 236
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 = Test product
Arm 1 - intervention 1 (test product)
Other: 1- Test dairy product containing specific ingredients
Placebo Comparator: 2 = Control product
Arm 2 - intervention 2 (control product)
Other: 2- Control dairy product without specific ingredients

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female
  • 21 - 60 years old
  • Experiencing upper gastric discomfort

Exclusion Criteria:

  • Participants with alarm symptoms (dysphagia, bleeding, involuntary weight loss clinically significant >10% of it habitual weight during the last 6 months).
  • Participants with diagnosed severe organic esophageal medical history (endoscopic eosophagitis A, B, C or D of Los Angeles classification, peptic stenosis, Barrett oesophagus, huge hiatus hernia or para-esophageal) gastric or duodenal ulcer or high digestive haemorrhage clinical history.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422980


Locations
Argentina
Hospital Italiano
BuenosAires, Argentina, 1116
Sponsors and Collaborators
Danone Research
  More Information

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01422980     History of Changes
Other Study ID Numbers: NU345
First Submitted: April 21, 2011
First Posted: August 25, 2011
Last Update Posted: October 10, 2016
Last Verified: October 2016

Keywords provided by Danone Research:
dairy product
upper gastric discomfort
adult