Status:

COMPLETED

Effects of a Supplement on Acute Respiratory Infections

Lead Sponsor:

Omnilife Manufactura, SA de CV

Collaborating Sponsors:

University of Guadalajara

Conditions:

Respiratory Tract Infection

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

The purpose of this study is to determine whether the consumption of a nutritional supplement with micronutrients and herbal extracts has an effect on the incidence of acute respiratory infections in ...

Detailed Description

We conducted a randomized, parallel, double-blind, placebo-controlled, 90-day clinical trial from January to April, 2012. All staff who worked at the Omnilife's Entrepreneur Support Department (CREO b...

Eligibility Criteria

Inclusion

  • Healthy adult subjects (without active respiratory infections, or without diseases that compromise immune system)
  • Who presented no abnormalities in their laboratory tests (active infections, immunosuppression, renal or hepatic impairment)
  • Who did not take drugs that affect the immune system (anti-inflammatory drugs, antibiotics, steroids).

Exclusion

  • Subjects with active acute respiratory infections.
  • Subjects with chronic respiratory disease requiring treatment other than bronchodilators at the time of assessment.
  • Subjects with diseases affecting the immune system (autoimmune illness, diabetes, etc.)
  • Pregnant women or currently nursing.
  • Subjects with cardiovascular disorders (uncontrolled hypertension) or neurological disorders (epilepsy).
  • Subjects with allergies to any components of the products.
  • Subjects with low treatment adherence (less than 80%).

Key Trial Info

Start Date :

January 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2012

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT02210156

Start Date

January 1 2012

End Date

April 1 2012

Last Update

August 7 2014

Active Locations (1)

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1

Omnilife

Guadalajara, Jalisco, Mexico, 44500