<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02210156</url>
  </required_header>
  <id_info>
    <org_study_id>Omnilife 01</org_study_id>
    <secondary_id>19/UG-JAL/2012</secondary_id>
    <nct_id>NCT02210156</nct_id>
  </id_info>
  <brief_title>Effects of a Supplement on Acute Respiratory Infections</brief_title>
  <official_title>Effects of a Dietary Supplement on the Incidence of Acute Respiratory Infections in Susceptible Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Omnilife Manufactura, SA de CV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Guadalajara</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Omnilife Manufactura, SA de CV</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the consumption of a nutritional supplement&#xD;
      with micronutrients and herbal extracts has an effect on the incidence of acute respiratory&#xD;
      infections in susceptible adults.&#xD;
&#xD;
      Our hypothesis is that subjects who consume the nutritional supplement will have a lower&#xD;
      incidence and duration of acute respiratory infections in comparison with the placebo group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We conducted a randomized, parallel, double-blind, placebo-controlled, 90-day clinical trial&#xD;
      from January to April, 2012. All staff who worked at the Omnilife's Entrepreneur Support&#xD;
      Department (CREO by its initials in Spanish) were invited to participate. This department&#xD;
      within Omnilife has a high incidence of acute respiratory infections (ARI) as reported&#xD;
      internally by the company's medical service (accounting for 55% of doctor visits within the&#xD;
      department in 2010) and hence, they represent a high number of individuals susceptible to&#xD;
      ARI.&#xD;
&#xD;
      We held a preliminary session with the department's entire staff to explain the procedures;&#xD;
      we asked subjects interested to participate in the study to sign an informed consent form and&#xD;
      fill a clinical history. The latter included an assessment of stress, using the Perceived&#xD;
      Stress Scale (in which higher scores indicate higher levels of stress), and physical&#xD;
      activity, using the International Physical Activity Questionnaire or IPAQ (in which physical&#xD;
      activity is categorized in three levels: light, moderate and vigorous).&#xD;
&#xD;
      In a second session the same week, participants visited the company's medical service for&#xD;
      measurements of their weight and height (in accordance with the International Society for the&#xD;
      Advancement of Kinanthropometry or ISAK standards), control laboratory tests and a medical&#xD;
      examination to rule out the presence of infections. Weight measurements were taken using a&#xD;
      Tanita BC553 Ironman Inner Scan Body Fat Scale (capacity of 150 kg, accuracy to 0.1 kg).&#xD;
      Height measurements were made using a Seca 206 Stadiometer (accuracy to 0.1 cm, measuring&#xD;
      range to 220 cm). Both measurements were performed by a two certified and standardized&#xD;
      anthropometrists. Body mass index (BMI) was subsequently calculated using both variables as&#xD;
      follows: BMI = weight in kg/(height in m)2.&#xD;
&#xD;
      The medical examination was performed by the attending physician and a nurse. It consisted of&#xD;
      an assessment of vital signs following procedures described in the literature and a physical&#xD;
      examination of bodily organs and systems. Temperature was measured using a Microlife MT 1931&#xD;
      digital thermometer (measuring range from 32 to 43.9°C, accuracy to 0.1°C). Heart and&#xD;
      respiratory rates were measured using a 3M Littmann Classic II S.E. stethoscope. Blood&#xD;
      pressure readings were taken using a 3M Littmann Classic II S.E. stethoscope and an Aneroid&#xD;
      Sphygmomanometer ce0483 (18-300 mmHg measurement range, accuracy to 2 mmHg).&#xD;
&#xD;
      Laboratory tests were conducted with the support of an external laboratory (Instituto&#xD;
      Diagnostico Especializado Arboledas, IDEA by its initials in Spanish). Included were a blood&#xD;
      test of six items (fasting glucose, uric acid, creatinine, blood urea nitrogen, cholesterol&#xD;
      and triglycerides) analyzed by the spectrophotometric method, a complete blood count with a&#xD;
      flow cytometry/microscopy analysis of platelets, and a spectroscopy analysis to assess liver&#xD;
      function. Subjects of laboratory analyses were tested after a 12-hour fast. This laboratory&#xD;
      has obtained quality control certification from the Quality Assurance for Laboratories&#xD;
      Program (PACAL) and the Internal Evaluation Quality Program (PREVECAL). In addition, its&#xD;
      staff is certified in clinical diagnosis by the National Association of Clinical Chemists&#xD;
      (CONAQUIC).&#xD;
&#xD;
      Subjects who met inclusion criteria were randomly assigned to two groups: one which received&#xD;
      the supplement (n=30), and a control group who received a placebo, which consisted in a&#xD;
      mixture of maltodextrins, colors and flavors. Every day two dietitians prepared the products,&#xD;
      who then gave the prepared products to two different supervisors who in turn gave the product&#xD;
      to each participant for consumption. The supervisors recorded product administration and&#xD;
      consumption for each participant on a control form.&#xD;
&#xD;
      Simultaneously, each week the supervisors provided each participant with an ARI symptom and&#xD;
      side effect diary to be filled in daily (indicating whether or not the symptom in question&#xD;
      had presented). Participants delivered the supervisors their filled-in diaries the following&#xD;
      week. Subjects were also requested not to self-medicate in the event they should feel any of&#xD;
      the symptoms and to notify the principal researcher and attending physician, who would make a&#xD;
      clinical assessment to confirm the presence or absence of ARI and provide any needed medical&#xD;
      treatment. In such cases, participants were not to be excluded from the study, but treatment&#xD;
      provided to them was documented. At the end of the supplementation period, the initial&#xD;
      assessments were performed again. Subjects were also asked about their perceptions of their&#xD;
      own health at that time compared to how they felt at the beginning of the study.&#xD;
&#xD;
      Quantitative variables are expressed as mean (SD). Qualitative variables are expressed as&#xD;
      frequency (%). Fisher's exact test was used to compare distribution percentages of&#xD;
      qualitative variables between groups and to compare the total proportion of ill subjects&#xD;
      across intervention groups using intent-to-treat and per-population concepts. The risk ratio&#xD;
      and the risk difference were also calculated for episodes of ARI. To compare the average of&#xD;
      quantitative variables between treatments, the Mann-Whitney U test was used. Statistical&#xD;
      analyzes were run using the SPSS program version 10 for Windows and Open Epi version 3.01;&#xD;
      p&lt;0.05 was considered as significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of acute respiratory infections</measure>
    <time_frame>90 days</time_frame>
    <description>Number of subjects with at least one episode of acute respiratory infection according to supplementation group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean episodes of acute respiratory infections</measure>
    <time_frame>90 days</time_frame>
    <description>Mean episodes of acute respiratory infections by supplementation group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean duration of acute respiratory infections</measure>
    <time_frame>90 days</time_frame>
    <description>Mean duration in days of acute respiratory infections by supplementation group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with more than one acute respiratory infection episode</measure>
    <time_frame>90 days</time_frame>
    <description>Number of subjects with more than one acute respiratory infection episode by supplementation group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absenteeism</measure>
    <time_frame>90 days</time_frame>
    <description>Number of subjects who reported absenteeism because of acute respiratory infections, by supplementation group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Episode-related medication</measure>
    <time_frame>90 days</time_frame>
    <description>Number of subjects who reported episode-related medication by supplementation group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose</measure>
    <time_frame>90 days</time_frame>
    <description>Changes in fasting glucose (final vs initial)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uric acid</measure>
    <time_frame>90 days</time_frame>
    <description>Changes in uric acid (final vs initial)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood urea nitrogen</measure>
    <time_frame>90 days</time_frame>
    <description>Changes in blood urea nitrogen (final vs initial)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>90 days</time_frame>
    <description>Changes in creatinine (final vs initial)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol</measure>
    <time_frame>90 days</time_frame>
    <description>Changes in cholesterol (final vs initial)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>90 days</time_frame>
    <description>Changes in triglycerides (final vs initial)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of acute respiratory infections</measure>
    <time_frame>90 days</time_frame>
    <description>Number of acute respiratory infections episodes by supplementation group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Respiratory Tract Infection</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two envelopes of the product in 240 ml of water in a disposable cup, 90 days of actual consumption.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omniplus Supreme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two envelopes of the product in 240 ml of water in a disposable cup, 90 days of actual consumption.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omniplus Supreme</intervention_name>
    <description>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.</description>
    <arm_group_label>Omniplus Supreme</arm_group_label>
    <other_name>Food supplement with micronutrients and plant extracts</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>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.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult subjects (without active respiratory infections, or without diseases&#xD;
             that compromise immune system)&#xD;
&#xD;
          -  Who presented no abnormalities in their laboratory tests (active infections,&#xD;
             immunosuppression, renal or hepatic impairment)&#xD;
&#xD;
          -  Who did not take drugs that affect the immune system (anti-inflammatory drugs,&#xD;
             antibiotics, steroids).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with active acute respiratory infections.&#xD;
&#xD;
          -  Subjects with chronic respiratory disease requiring treatment other than&#xD;
             bronchodilators at the time of assessment.&#xD;
&#xD;
          -  Subjects with diseases affecting the immune system (autoimmune illness, diabetes,&#xD;
             etc.)&#xD;
&#xD;
          -  Pregnant women or currently nursing.&#xD;
&#xD;
          -  Subjects with cardiovascular disorders (uncontrolled hypertension) or neurological&#xD;
             disorders (epilepsy).&#xD;
&#xD;
          -  Subjects with allergies to any components of the products.&#xD;
&#xD;
          -  Subjects with low treatment adherence (less than 80%).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>María F. Bernal-Orozco, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Omnilife Manufactura, SA de CV</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Margarita Posada-Falomir, B.Sc.(Nutr.)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Omnilife Manufactura, SA de CV</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rafael Ortega-Orozco, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Omnilife Manufactura, SA de CV</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elvia Silva-Villanueva, M.Sc.(O.H).</last_name>
    <role>Principal Investigator</role>
    <affiliation>Omnilife Manufactura, SA de CV</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gabriela Macedo-Ojeda, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Guadalajara</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yolanda F. Marquez-Sandoval, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Guadalajara</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Barbara Vizmanos-Lamotte, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Guadalajara</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Omnilife</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44500</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
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    <citation>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.</citation>
  </reference>
  <reference>
    <citation>Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.</citation>
    <PMID>12900694</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>Castelloti C. Algas. Su uso terapéutico y nutricional. 1st ed. Madrid: Editorial Dilema; 2008.</citation>
  </reference>
  <reference>
    <citation>Luabeya KK, Mpontshane N, Mackay M, Ward H, Elson I, Chhagan M, Tomkins A, Van den Broeck J, Bennish ML. Zinc or multiple micronutrient supplementation to reduce diarrhea and respiratory disease in South African children: a randomized controlled trial. PLoS One. 2007 Jun 27;2(6):e541. doi: 10.1371/journal.pone.0000541.</citation>
    <PMID>17593956</PMID>
  </reference>
  <reference>
    <citation>McNair F, Heuchert JWP. Manual for the profile of mood states. San Diego (CA): Educational and Industrical Testing Service; 1971.</citation>
  </reference>
  <reference>
    <citation>Mills S, Bone K. The essential guide to herbal safety. 1st ed. Philadelphia: Elsevier; 2005.</citation>
  </reference>
  <reference>
    <citation>Maggini S, Wintergerst ES, Beveridge S, Hornig DH. Selected vitamins and trace elements support immune function by strengthening epithelial barriers and cellular and humoral immune responses. Br J Nutr. 2007 Oct;98 Suppl 1:S29-35. doi: 10.1017/S0007114507832971.</citation>
    <PMID>17922955</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Respiratory tract infection</keyword>
  <keyword>Incidence</keyword>
  <keyword>Dietary supplements</keyword>
  <keyword>Micronutrients</keyword>
  <keyword>Plant extracts</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Micronutrients</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02210156
org study id: Omnilife 01
secondary id: 19/UG-JAL/2012
nct id: NCT02210156
lead sponsor: 
collaborator: 
has dmc: No
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.
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 by its initials in Spanish) were invited to participate. This department
      within Omnilife has a high incidence of acute respiratory infections (ARI) as reported
      internally by the company's medical service (accounting for 55% of doctor visits within the
      department in 2010) and hence, they represent a high number of individuals susceptible to
      ARI.

      We held a preliminary session with the department's entire staff to explain the procedures;
      we asked subjects interested to participate in the study to sign an informed consent form and
      fill a clinical history. The latter included an assessment of stress, using the Perceived
      Stress Scale (in which higher scores indicate higher levels of stress), and physical
      activity, using the International Physical Activity Questionnaire or IPAQ (in which physical
      activity is categorized in three levels: light, moderate and vigorous).

      In a second session the same week, participants visited the company's medical service for
      measurements of their weight and height (in accordance with the International Society for the
      Advancement of Kinanthropometry or ISAK standards), control laboratory tests and a medical
      examination to rule out the presence of infections. Weight measurements were taken using a
      Tanita BC553 Ironman Inner Scan Body Fat Scale (capacity of 150 kg, accuracy to 0.1 kg).
      Height measurements were made using a Seca 206 Stadiometer (accuracy to 0.1 cm, measuring
      range to 220 cm). Both measurements were performed by a two certified and standardized
      anthropometrists. Body mass index (BMI) was subsequently calculated using both variables as
      follows: BMI = weight in kg/(height in m)2.

      The medical examination was performed by the attending physician and a nurse. It consisted of
      an assessment of vital signs following procedures described in the literature and a physical
      examination of bodily organs and systems. Temperature was measured using a Microlife MT 1931
      digital thermometer (measuring range from 32 to 43.9°C, accuracy to 0.1°C). Heart and
      respiratory rates were measured using a 3M Littmann Classic II S.E. stethoscope. Blood
      pressure readings were taken using a 3M Littmann Classic II S.E. stethoscope and an Aneroid
      Sphygmomanometer ce0483 (18-300 mmHg measurement range, accuracy to 2 mmHg).

      Laboratory tests were conducted with the support of an external laboratory (Instituto
      Diagnostico Especializado Arboledas, IDEA by its initials in Spanish). Included were a blood
      test of six items (fasting glucose, uric acid, creatinine, blood urea nitrogen, cholesterol
      and triglycerides) analyzed by the spectrophotometric method, a complete blood count with a
      flow cytometry/microscopy analysis of platelets, and a spectroscopy analysis to assess liver
      function. Subjects of laboratory analyses were tested after a 12-hour fast. This laboratory
      has obtained quality control certification from the Quality Assurance for Laboratories
      Program (PACAL) and the Internal Evaluation Quality Program (PREVECAL). In addition, its
      staff is certified in clinical diagnosis by the National Association of Clinical Chemists
      (CONAQUIC).

      Subjects who met inclusion criteria were randomly assigned to two groups: one which received
      the supplement (n=30), and a control group who received a placebo, which consisted in a
      mixture of maltodextrins, colors and flavors. Every day two dietitians prepared the products,
      who then gave the prepared products to two different supervisors who in turn gave the product
      to each participant for consumption. The supervisors recorded product administration and
      consumption for each participant on a control form.

      Simultaneously, each week the supervisors provided each participant with an ARI symptom and
      side effect diary to be filled in daily (indicating whether or not the symptom in question
      had presented). Participants delivered the supervisors their filled-in diaries the following
      week. Subjects were also requested not to self-medicate in the event they should feel any of
      the symptoms and to notify the principal researcher and attending physician, who would make a
      clinical assessment to confirm the presence or absence of ARI and provide any needed medical
      treatment. In such cases, participants were not to be excluded from the study, but treatment
      provided to them was documented. At the end of the supplementation period, the initial
      assessments were performed again. Subjects were also asked about their perceptions of their
      own health at that time compared to how they felt at the beginning of the study.

      Quantitative variables are expressed as mean (SD). Qualitative variables are expressed as
      frequency (%). Fisher's exact test was used to compare distribution percentages of
      qualitative variables between groups and to compare the total proportion of ill subjects
      across intervention groups using intent-to-treat and per-population concepts. The risk ratio
      and the risk difference were also calculated for episodes of ARI. To compare the average of
      quantitative variables between treatments, the Mann-Whitney U test was used. Statistical
      analyzes were run using the SPSS program version 10 for Windows and Open Epi version 3.01;
      p<0.05 was considered as significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Incidence of acute respiratory infections
time frame: 90 days
description: Number of subjects with at least one episode of acute respiratory infection according to supplementation group.
measure: Mean episodes of acute respiratory infections
time frame: 90 days
description: Mean episodes of acute respiratory infections by supplementation group
measure: Mean duration of acute respiratory infections
time frame: 90 days
description: Mean duration in days of acute respiratory infections by supplementation group
measure: Number of subjects with more than one acute respiratory infection episode
time frame: 90 days
description: Number of subjects with more than one acute respiratory infection episode by supplementation group
measure: Absenteeism
time frame: 90 days
description: Number of subjects who reported absenteeism because of acute respiratory infections, by supplementation group
measure: Episode-related medication
time frame: 90 days
description: Number of subjects who reported episode-related medication by supplementation group
measure: Fasting glucose
time frame: 90 days
description: Changes in fasting glucose (final vs initial)
measure: Uric acid
time frame: 90 days
description: Changes in uric acid (final vs initial)
measure: Blood urea nitrogen
time frame: 90 days
description: Changes in blood urea nitrogen (final vs initial)
measure: Creatinine
time frame: 90 days
description: Changes in creatinine (final vs initial)
measure: Cholesterol
time frame: 90 days
description: Changes in cholesterol (final vs initial)
measure: Triglycerides
time frame: 90 days
description: Changes in triglycerides (final vs initial)
measure: Number of acute respiratory infections
time frame: 90 days
description: Number of acute respiratory infections episodes by supplementation group.
arm group label: Placebo
arm group type: Placebo Comparator
description: Two envelopes of the product in 240 ml of water in a disposable cup, 90 days of actual consumption.
arm group label: Omniplus Supreme
arm group type: Experimental
description: Two envelopes of the product in 240 ml of water in a disposable cup, 90 days of actual consumption.
intervention type: Dietary Supplement
intervention name: Omniplus Supreme
description: 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.
arm group label: Omniplus Supreme
other name: Food supplement with micronutrients and plant extracts
intervention type: Other
intervention name: Placebo
description: 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.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: María F. Bernal-Orozco, Ph.D.
role: Study Director
affiliation: Omnilife Manufactura, SA de CV
last name: Margarita Posada-Falomir, B.Sc.(Nutr.)
role: Principal Investigator
affiliation: Omnilife Manufactura, SA de CV
last name: Rafael Ortega-Orozco, M.D.
role: Principal Investigator
affiliation: Omnilife Manufactura, SA de CV
last name: Elvia Silva-Villanueva, M.Sc.(O.H).
role: Principal Investigator
affiliation: Omnilife Manufactura, SA de CV
last name: Gabriela Macedo-Ojeda, Ph.D.
role: Principal Investigator
affiliation: University of Guadalajara
last name: Yolanda F. Marquez-Sandoval, Ph.D.
role: Principal Investigator
affiliation: University of Guadalajara
last name: Barbara Vizmanos-Lamotte, M.D., Ph.D
role: Principal Investigator
affiliation: University of Guadalajara
facility: 
country: Mexico
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citation: 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.
citation: 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.
citation: Castelloti C. Algas. Su uso terapéutico y nutricional. 1st ed. Madrid: Editorial Dilema; 2008.
citation: Luabeya KK, Mpontshane N, Mackay M, Ward H, Elson I, Chhagan M, Tomkins A, Van den Broeck J, Bennish ML. Zinc or multiple micronutrient supplementation to reduce diarrhea and respiratory disease in South African children: a randomized controlled trial. PLoS One. 2007 Jun 27;2(6):e541. doi: 10.1371/journal.pone.0000541.
PMID: 17593956
citation: McNair F, Heuchert JWP. Manual for the profile of mood states. San Diego (CA): Educational and Industrical Testing Service; 1971.
citation: Mills S, Bone K. The essential guide to herbal safety. 1st ed. Philadelphia: Elsevier; 2005.
citation: Maggini S, Wintergerst ES, Beveridge S, Hornig DH. Selected vitamins and trace elements support immune function by strengthening epithelial barriers and cellular and humoral immune responses. Br J Nutr. 2007 Oct;98 Suppl 1:S29-35. doi: 10.1017/S0007114507832971.
PMID: 17922955
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Micronutrients