Effect of Consumption of Dairy Product on Upper Gastric Discomfort

NCT ID: NCT01422980

Last Updated: 2016-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Upper Gastric Discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 = Test product

Arm 1 - intervention 1 (test product)

Group Type ACTIVE_COMPARATOR

1- Test dairy product containing specific ingredients

Intervention Type OTHER

2 = Control product

Arm 2 - intervention 2 (control product)

Group Type PLACEBO_COMPARATOR

2- Control dairy product without specific ingredients

Intervention Type OTHER

Interventions

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1- Test dairy product containing specific ingredients

Intervention Type OTHER

2- Control dairy product without specific ingredients

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Italiano

Buenos Aires, , Argentina

Site Status

Countries

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Argentina

Other Identifiers

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NU345

Identifier Type: -

Identifier Source: org_study_id

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