Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-07 @ 8:51 AM
Study NCT ID:
NCT02210156
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2014-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Supplement on Acute Respiratory Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D010936', 'term': 'Plant Extracts'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000078622', 'term': 'Nutrients'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-05', 'studyFirstSubmitDate': '2014-08-04', 'studyFirstSubmitQcDate': '2014-08-04', 'lastUpdatePostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of acute respiratory infections', 'timeFrame': '90 days', 'description': 'Number of subjects with at least one episode of acute respiratory infection according to supplementation group.'}], 'secondaryOutcomes': [{'measure': 'Mean episodes of acute respiratory infections', 'timeFrame': '90 days', 'description': 'Mean episodes of acute respiratory infections by supplementation group'}, {'measure': 'Mean duration of acute respiratory infections', 'timeFrame': '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', 'timeFrame': '90 days', 'description': 'Number of subjects with more than one acute respiratory infection episode by supplementation group'}, {'measure': 'Absenteeism', 'timeFrame': '90 days', 'description': 'Number of subjects who reported absenteeism because of acute respiratory infections, by supplementation group'}, {'measure': 'Episode-related medication', 'timeFrame': '90 days', 'description': 'Number of subjects who reported episode-related medication by supplementation group'}, {'measure': 'Fasting glucose', 'timeFrame': '90 days', 'description': 'Changes in fasting glucose (final vs initial)'}, {'measure': 'Uric acid', 'timeFrame': '90 days', 'description': 'Changes in uric acid (final vs initial)'}, {'measure': 'Blood urea nitrogen', 'timeFrame': '90 days', 'description': 'Changes in blood urea nitrogen (final vs initial)'}, {'measure': 'Creatinine', 'timeFrame': '90 days', 'description': 'Changes in creatinine (final vs initial)'}, {'measure': 'Cholesterol', 'timeFrame': '90 days', 'description': 'Changes in cholesterol (final vs initial)'}, {'measure': 'Triglycerides', 'timeFrame': '90 days', 'description': 'Changes in triglycerides (final vs initial)'}, {'measure': 'Number of acute respiratory infections', 'timeFrame': '90 days', 'description': 'Number of acute respiratory infections episodes by supplementation group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiratory tract infection', 'Incidence', 'Dietary supplements', 'Micronutrients', 'Plant extracts'], 'conditions': ['Respiratory Tract Infection']}, 'referencesModule': {'references': [{'pmid': '16253889', 'type': 'BACKGROUND', 'citation': 'Eccles R. Understanding the symptoms of the common cold and influenza. Lancet Infect Dis. 2005 Nov;5(11):718-25. doi: 10.1016/S1473-3099(05)70270-X.'}, {'pmid': '12495459', 'type': 'BACKGROUND', 'citation': 'Calder PC, Kew S. The immune system: a target for functional foods? Br J Nutr. 2002 Nov;88 Suppl 2:S165-77. doi: 10.1079/BJN2002682.'}, {'pmid': '21166296', 'type': 'BACKGROUND', 'citation': 'Manoharan A, Winter J. Tackling upper respiratory tract infections. Practitioner. 2010 Nov;254(1734):25-8, 2-3.'}, {'pmid': '17726308', 'type': 'BACKGROUND', 'citation': 'Wintergerst ES, Maggini S, Hornig DH. Contribution of selected vitamins and trace elements to immune function. Ann Nutr Metab. 2007;51(4):301-23. doi: 10.1159/000107673. Epub 2007 Aug 28.'}, {'pmid': '17549893', 'type': 'BACKGROUND', 'citation': 'Ramirez MT, Hernandez RL. Factor structure of the Perceived Stress Scale (PSS) in a sample from Mexico. Span J Psychol. 2007 May;10(1):199-206. doi: 10.1017/s1138741600006466.'}, {'pmid': '16756533', 'type': 'BACKGROUND', 'citation': 'Stephen AI, Avenell A. A systematic review of multivitamin and multimineral supplementation for infection. J Hum Nutr Diet. 2006 Jun;19(3):179-90. doi: 10.1111/j.1365-277X.2006.00694.x.'}, {'pmid': '19961353', 'type': 'BACKGROUND', 'citation': 'Goyal SK, Samsher, Goyal RK. Stevia (Stevia rebaudiana) a bio-sweetener: a review. Int J Food Sci Nutr. 2010 Feb;61(1):1-10. doi: 10.3109/09637480903193049.'}, {'pmid': '21694984', 'type': 'BACKGROUND', 'citation': 'Gohil KJ, Patel JA, Gajjar AK. Pharmacological Review on Centella asiatica: A Potential Herbal Cure-all. 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Epub 2009 Sep 1.'}, {'pmid': '17125579', 'type': 'BACKGROUND', 'citation': "Karkos PD, Leong SC, Arya AK, Papouliakos SM, Apostolidou MT, Issing WJ. 'Complementary ENT': a systematic review of commonly used supplements. J Laryngol Otol. 2007 Aug;121(8):779-82. doi: 10.1017/S002221510600449X. Epub 2006 Nov 24."}, {'pmid': '21173411', 'type': 'BACKGROUND', 'citation': 'Barrett B, Brown R, Rakel D, Mundt M, Bone K, Barlow S, Ewers T. Echinacea for treating the common cold: a randomized trial. Ann Intern Med. 2010 Dec 21;153(12):769-77. doi: 10.7326/0003-4819-153-12-201012210-00003.'}, {'pmid': '9250133', 'type': 'BACKGROUND', 'citation': 'Chandra RK. Nutrition and the immune system: an introduction. Am J Clin Nutr. 1997 Aug;66(2):460S-463S. doi: 10.1093/ajcn/66.2.460S.'}, {'pmid': '11781377', 'type': 'BACKGROUND', 'citation': 'Field CJ, Johnson IR, Schley PD. Nutrients and their role in host resistance to infection. J Leukoc Biol. 2002 Jan;71(1):16-32.'}, {'pmid': '23326930', 'type': 'BACKGROUND', 'citation': 'Rosler D, Fuchs N, Markolin G, Edler B, Kuklinski B, Kastenbauer T. [Reduction of influenza-like infections by a phytoextract-vitamin-combination: a randomized, double-blind, placebo-controlled study]. MMW Fortschr Med. 2012 Dec 17;154 Suppl 4:115-22. German.'}, {'pmid': '21859655', 'type': 'BACKGROUND', 'citation': 'Liu Y, Jing H, Wang J, Zhang R, Zhang Y, Zhang Y, Xu Q, Yu X, Xue C. Micronutrients decrease incidence of common infections in type 2 diabetic outpatients. Asia Pac J Clin Nutr. 2011;20(3):375-82.'}, {'pmid': '15126020', 'type': 'BACKGROUND', 'citation': 'Linday LA, Dolitsky JN, Shindledecker RD. Nutritional supplements as adjunctive therapy for children with chronic/recurrent sinusitis: pilot research. Int J Pediatr Otorhinolaryngol. 2004 Jun;68(6):785-93. doi: 10.1016/j.ijporl.2004.01.009.'}, {'pmid': '15562899', 'type': 'BACKGROUND', 'citation': 'Linday LA, Shindledecker RD, Tapia-Mendoza J, Dolitsky JN. Effect of daily cod liver oil and a multivitamin-mineral supplement with selenium on upper respiratory tract pediatric visits by young, inner-city, Latino children: randomized pediatric sites. Ann Otol Rhinol Laryngol. 2004 Nov;113(11):891-901. doi: 10.1177/000348940411301108.'}, {'pmid': '14985222', 'type': 'BACKGROUND', 'citation': 'Penny ME, Marin RM, Duran A, Peerson JM, Lanata CF, Lonnerdal B, Black RE, Brown KH. Randomized controlled trial of the effect of daily supplementation with zinc or multiple micronutrients on the morbidity, growth, and micronutrient status of young Peruvian children. Am J Clin Nutr. 2004 Mar;79(3):457-65. doi: 10.1093/ajcn/79.3.457.'}, {'pmid': '17299460', 'type': 'BACKGROUND', 'citation': 'Begin F, Santizo MC, Peerson JM, Torun B, Brown KH. 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BMJ. 2005 Aug 6;331(7512):324-9. doi: 10.1136/bmj.331.7512.324.'}, {'pmid': '21387013', 'type': 'BACKGROUND', 'citation': 'Croci DO, Cumashi A, Ushakova NA, Preobrazhenskaya ME, Piccoli A, Totani L, Ustyuzhanina NE, Bilan MI, Usov AI, Grachev AA, Morozevich GE, Berman AE, Sanderson CJ, Kelly M, Di Gregorio P, Rossi C, Tinari N, Iacobelli S, Rabinovich GA, Nifantiev NE; Consorzio Interuniversitario Nazionale per la Bio-Oncologia (CINBO), Italy. Fucans, but not fucomannoglucuronans, determine the biological activities of sulfated polysaccharides from Laminaria saccharina brown seaweed. PLoS One. 2011 Feb 28;6(2):e17283. doi: 10.1371/journal.pone.0017283.'}, {'pmid': '10944478', 'type': 'BACKGROUND', 'citation': 'Erickson KL, Medina EA, Hubbard NE. Micronutrients and innate immunity. J Infect Dis. 2000 Sep;182 Suppl 1:S5-10. doi: 10.1086/315922.'}, {'pmid': '17182688', 'type': 'BACKGROUND', 'citation': 'Lofgren E, Fefferman NH, Naumov YN, Gorski J, Naumova EN. Influenza seasonality: underlying causes and modeling theories. J Virol. 2007 Jun;81(11):5429-36. doi: 10.1128/JVI.01680-06. Epub 2006 Dec 20. No abstract available.'}, {'pmid': '21322286', 'type': 'BACKGROUND', 'citation': 'Nahas R, Balla A. Complementary and alternative medicine for prevention and treatment of the common cold. Can Fam Physician. 2011 Jan;57(1):31-6.'}, {'pmid': '21506934', 'type': 'BACKGROUND', 'citation': 'Puertollano MA, Puertollano E, de Cienfuegos GA, de Pablo MA. Dietary antioxidants: immunity and host defense. Curr Top Med Chem. 2011;11(14):1752-66. doi: 10.2174/156802611796235107.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '6668417', 'type': 'BACKGROUND', 'citation': 'Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. 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Philadelphia: Elsevier; 2005.'}, {'pmid': '17922955', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nOur 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.', 'detailedDescription': "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.\n\nWe 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).\n\nIn 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.\n\nThe 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).\n\nLaboratory 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).\n\nSubjects 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.\n\nSimultaneously, 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.\n\nQuantitative 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult subjects (without active respiratory infections, or without diseases that compromise immune system)\n* Who presented no abnormalities in their laboratory tests (active infections, immunosuppression, renal or hepatic impairment)\n* Who did not take drugs that affect the immune system (anti-inflammatory drugs, antibiotics, steroids).\n\nExclusion Criteria:\n\n* Subjects with active acute respiratory infections.\n* Subjects with chronic respiratory disease requiring treatment other than bronchodilators at the time of assessment.\n* Subjects with diseases affecting the immune system (autoimmune illness, diabetes, etc.)\n* Pregnant women or currently nursing.\n* Subjects with cardiovascular disorders (uncontrolled hypertension) or neurological disorders (epilepsy).\n* Subjects with allergies to any components of the products.\n* Subjects with low treatment adherence (less than 80%).'}, 'identificationModule': {'nctId': 'NCT02210156', 'briefTitle': 'Effects of a Supplement on Acute Respiratory Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Omnilife Manufactura, SA de CV'}, 'officialTitle': 'Effects of a Dietary Supplement on the Incidence of Acute Respiratory Infections in Susceptible Adults', 'orgStudyIdInfo': {'id': 'Omnilife 01'}, 'secondaryIdInfos': [{'id': '19/UG-JAL/2012', 'type': 'OTHER', 'domain': 'Registro Estatal de Investigacion. Secretaria de Salud. Gobierno de Jalisco. Mexico.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Two envelopes of the product in 240 ml of water in a disposable cup, 90 days of actual consumption.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Omniplus Supreme', 'description': 'Two envelopes of the product in 240 ml of water in a disposable cup, 90 days of actual consumption.', 'interventionNames': ['Dietary Supplement: Omniplus Supreme']}], 'interventions': [{'name': 'Omniplus Supreme', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Food supplement with micronutrients and plant extracts'], '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.', 'armGroupLabels': ['Omniplus Supreme']}, {'name': 'Placebo', 'type': 'OTHER', '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44500', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Omnilife', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'María F. Bernal-Orozco, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Omnilife Manufactura, SA de CV'}, {'name': 'Margarita Posada-Falomir, B.Sc.(Nutr.)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Omnilife Manufactura, SA de CV'}, {'name': 'Rafael Ortega-Orozco, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Omnilife Manufactura, SA de CV'}, {'name': 'Elvia Silva-Villanueva, M.Sc.(O.H).', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Omnilife Manufactura, SA de CV'}, {'name': 'Gabriela Macedo-Ojeda, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guadalajara'}, {'name': 'Yolanda F. Marquez-Sandoval, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guadalajara'}, {'name': 'Barbara Vizmanos-Lamotte, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guadalajara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Omnilife Manufactura, SA de CV', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Guadalajara', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}