Effects of a Supplement on Acute Respiratory Infections

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 susceptible adults.

Our hypothesis is that subjects who consume the nutritional supplement will have a lower incidence and duration of acute respiratory infections in comparison with the placebo group.

Conditions

• Respiratory Tract Infection

Interventions

DIETARY_SUPPLEMENT

Omniplus Supreme

Two dietitians prepared the products (one preparer per product) by dissolving two envelopes of 20 ml of the product in 240 ml of water in a disposable cup, every day from Monday to Saturday during the intervention period (90 days of actual consumption). In order to maintain blinding, these dietitians then gave the prepared cups to two different supervisors who in turn gave the product to each participant for consumption (once-daily doses). The preparation and delivery of the product was carried out during two work shifts (morning and afternoon), depending on each participants work schedule. The supervisors recorded product administration and consumption for each participant on a control form.

OTHER

Placebo

A product with maltodextrins, flavors and colorants without vitamins, minerals and plant extracts. Two dietitians prepared the products (one preparer per product) by dissolving two envelopes of 20 ml of the product in 240 ml of water in a disposable cup, every day from Monday to Saturday during the intervention period (90 days of actual consumption). In order to maintain blinding, these dietitians then gave the prepared cups to two different supervisors who in turn gave the product to each participant for consumption (once-daily doses). The preparation and delivery of the product was carried out during two work shifts (morning and afternoon), depending on each participants work schedule. The supervisors recorded product administration and consumption for each participant on a control form.

Sponsors & Collaborators

• University of Guadalajara

  collaborator OTHER

• Omnilife Manufactura, SA de CV

  lead INDUSTRY

Principal Investigators

• María F. Bernal-Orozco, Ph.D. · Omnilife Manufactura, SA de CV

• Margarita Posada-Falomir, B.Sc.(Nutr.) · Omnilife Manufactura, SA de CV

• Rafael Ortega-Orozco, M.D. · Omnilife Manufactura, SA de CV

• Elvia Silva-Villanueva, M.Sc.(O.H). · Omnilife Manufactura, SA de CV

• Gabriela Macedo-Ojeda, Ph.D. · University of Guadalajara

• Yolanda F. Marquez-Sandoval, Ph.D. · University of Guadalajara

• Barbara Vizmanos-Lamotte, M.D., Ph.D · University of Guadalajara

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2012-04-30

Completion

2012-04-30

Countries

• Mexico

Study Locations