Effects of a Supplement on Acute Respiratory Infections

NCT02210156 | Completed

• 2 other identifiers: Omnilife 0119/UG-JAL/2012
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 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

Keywords

Respiratory tract infection; Incidence; Dietary supplements; Micronutrients; Plant extracts

Outcome Measures

Primary Outcomes (1)

• Incidence of acute respiratory infections

  Number of subjects with at least one episode of acute respiratory infection according to supplementation group.

  90 days

Secondary Outcomes (12)

• Mean episodes of acute respiratory infections

  90 days

• Mean duration of acute respiratory infections

  90 days

• Number of subjects with more than one acute respiratory infection episode

  90 days

• Absenteeism

  90 days

• Episode-related medication

  90 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Two envelopes of the product in 240 ml of water in a disposable cup, 90 days of actual consumption.

Other: Placebo

Omniplus Supreme

EXPERIMENTAL

Two envelopes of the product in 240 ml of water in a disposable cup, 90 days of actual consumption.

Dietary Supplement: Omniplus Supreme

Interventions

Omniplus Supreme DIETARY_SUPPLEMENT

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.

Also known as: Food supplement with micronutrients and plant extracts

Omniplus Supreme

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Omnilife Manufactura, SA de CV: lead
• University of Guadalajara: collaborator

Study Sites (1)

Omnilife

Guadalajara, Jalisco, 44500, Mexico

Location

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MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Dietary Supplements; Micronutrients; Plant Extracts

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Officials

• María F. Bernal-Orozco, Ph.D.

  Omnilife Manufactura, SA de CV

  STUDY DIRECTOR

• Margarita Posada-Falomir, B.Sc.(Nutr.)

  Omnilife Manufactura, SA de CV

  PRINCIPAL INVESTIGATOR

• Rafael Ortega-Orozco, M.D.

  Omnilife Manufactura, SA de CV

  PRINCIPAL INVESTIGATOR

• Elvia Silva-Villanueva, M.Sc.(O.H).

  Omnilife Manufactura, SA de CV

  PRINCIPAL INVESTIGATOR

• Gabriela Macedo-Ojeda, Ph.D.

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

• Yolanda F. Marquez-Sandoval, Ph.D.

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

• Barbara Vizmanos-Lamotte, M.D., Ph.D

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 6, 2014
• Study Start: January 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 7, 2014

Record last verified: 2014-08

Locations

ME (1)