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Effects of a Supplement on Acute Respiratory Infections

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.
 
ClinicalTrials.gov Identifier: NCT02210156
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : August 7, 2014
Sponsor:
Collaborator:
University of Guadalajara
Information provided by (Responsible Party):
Omnilife Manufactura, SA de CV

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.


Condition or disease Intervention/treatment Phase
Respiratory Tract Infection Dietary Supplement: Omniplus Supreme Other: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of a Dietary Supplement on the Incidence of Acute Respiratory Infections in Susceptible Adults
Study Start Date : January 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Two envelopes of the product in 240 ml of water in a disposable cup, 90 days of actual consumption.
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.

Experimental: Omniplus Supreme
Two envelopes of the product in 240 ml of water in a disposable cup, 90 days of actual consumption.
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 Name: Food supplement with micronutrients and plant extracts




Primary Outcome Measures :
  1. Incidence of acute respiratory infections [ Time Frame: 90 days ]
    Number of subjects with at least one episode of acute respiratory infection according to supplementation group.


Secondary Outcome Measures :
  1. Mean episodes of acute respiratory infections [ Time Frame: 90 days ]
    Mean episodes of acute respiratory infections by supplementation group

  2. Mean duration of acute respiratory infections [ Time Frame: 90 days ]
    Mean duration in days of acute respiratory infections by supplementation group

  3. Number of subjects with more than one acute respiratory infection episode [ Time Frame: 90 days ]
    Number of subjects with more than one acute respiratory infection episode by supplementation group

  4. Absenteeism [ Time Frame: 90 days ]
    Number of subjects who reported absenteeism because of acute respiratory infections, by supplementation group

  5. Episode-related medication [ Time Frame: 90 days ]
    Number of subjects who reported episode-related medication by supplementation group

  6. Fasting glucose [ Time Frame: 90 days ]
    Changes in fasting glucose (final vs initial)

  7. Uric acid [ Time Frame: 90 days ]
    Changes in uric acid (final vs initial)

  8. Blood urea nitrogen [ Time Frame: 90 days ]
    Changes in blood urea nitrogen (final vs initial)

  9. Creatinine [ Time Frame: 90 days ]
    Changes in creatinine (final vs initial)

  10. Cholesterol [ Time Frame: 90 days ]
    Changes in cholesterol (final vs initial)

  11. Triglycerides [ Time Frame: 90 days ]
    Changes in triglycerides (final vs initial)

  12. Number of acute respiratory infections [ Time Frame: 90 days ]
    Number of acute respiratory infections episodes by supplementation group.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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%).

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): NCT02210156


Locations
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Mexico
Omnilife
Guadalajara, Jalisco, Mexico, 44500
Sponsors and Collaborators
Omnilife Manufactura, SA de CV
University of Guadalajara
Investigators
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Study Director: María F. Bernal-Orozco, Ph.D. Omnilife Manufactura, SA de CV
Principal Investigator: 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

Publications:
Gestal-Otero JJ, Takkouche B, Blasco-Huelva P. Infecciones respiratorias agudas. Gripe. En: Piédrola-Gil G, editor. 1oa ed. Medicina preventiva y salud pública. Barcelona: Masson; 2001. p. 491-505
International Physical Activity Questionnaire [Web site]; 2005 [access november 4th 2011]. IPAQ Research Committee. Guidelines for data processing and analysis of the International Physical Activity Questionnaire (IPAQ). Short and long forms. Available in: http://www.ipaq.ki.se/scoring.pdf.
Marfell-Jomes M, Olds T, Stewart A, Carter L. Estándares internacionales para la evaluación antropométrica. Revisión 2008. South Africa: Sociedad Internacional para el Avance de la Cineantropometría; 2008.
World Health Organization [Web site]. Geneva: The Organization; 2006 [updated november 11th 2011; access november 11th 2011]. BMI classification. Available in: http://apps.who.int/bmi/index.jsp?introPage=intro_3.html.
Vizmanos B, Bernal MF. Signos vitales. In: López-Uriarte P, Hunot C, Altamirano M, Macedo G, Vizmanos B, editors. Manual de prácticas de evaluación del estado nutricio. 1st ed. Guadalajara: La noche; 2007. p. 25-30.
Gupta S, Rajauria G, Sbu-Ghannam N. Study of the microbial diversity and antimicrobial properties of Irish edible brown seaweeds. Int J Food Sci Technol. 2010;45:482-9.
Jensen GS, Ginsberg DJ, Huerta P, Citton M, Drapeau C. Consumption of Aphanizomenon flos-aquae has rapid effects on the circulation and function of immune cells in humans. A novel approach to nutritional mobilization of the immune system. JANA 2000;2:50-8.
Castelloti C. Algas. Su uso terapéutico y nutricional. 1st ed. Madrid: Editorial Dilema; 2008.
McNair F, Heuchert JWP. Manual for the profile of mood states. San Diego (CA): Educational and Industrical Testing Service; 1971.
Mills S, Bone K. The essential guide to herbal safety. 1st ed. Philadelphia: Elsevier; 2005.

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Responsible Party: Omnilife Manufactura, SA de CV
ClinicalTrials.gov Identifier: NCT02210156     History of Changes
Other Study ID Numbers: Omnilife 01
19/UG-JAL/2012 ( Other Identifier: Registro Estatal de Investigacion. Secretaria de Salud. Gobierno de Jalisco. Mexico. )
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014
Keywords provided by Omnilife Manufactura, SA de CV:
Respiratory tract infection
Incidence
Dietary supplements
Micronutrients
Plant extracts
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs