Effects of a Supplement on Acute Respiratory Infections

Respiratory Tract Infection Clinical Trial

Official title:

Effects of a Dietary Supplement on the Incidence of Acute Respiratory Infections in Susceptible Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210156
• Other study ID #: Omnilife 01
• Secondary ID: 19/UG-JAL/2012
• Status: Completed
• Phase: N/A
• First received: August 4, 2014
• Last updated: August 5, 2014
• Start date: January 2012
• Est. completion date: April 2012

Study information

• Verified date: August 2014
• Source: Omnilife Manufactura, SA de CV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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%).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Mexico	Omnilife	Guadalajara	Jalisco

Sponsors (2)

Lead Sponsor	Collaborator
Omnilife Manufactura, SA de CV	University of Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (41)

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute respiratory infections	Number of subjects with at least one episode of acute respiratory infection according to supplementation group.	90 days	No
Secondary	Mean episodes of acute respiratory infections	Mean episodes of acute respiratory infections by supplementation group	90 days	No
Secondary	Mean duration of acute respiratory infections	Mean duration in days of acute respiratory infections by supplementation group	90 days	No
Secondary	Number of subjects with more than one acute respiratory infection episode	Number of subjects with more than one acute respiratory infection episode by supplementation group	90 days	No
Secondary	Absenteeism	Number of subjects who reported absenteeism because of acute respiratory infections, by supplementation group	90 days	No
Secondary	Episode-related medication	Number of subjects who reported episode-related medication by supplementation group	90 days	No
Secondary	Fasting glucose	Changes in fasting glucose (final vs initial)	90 days	Yes
Secondary	Uric acid	Changes in uric acid (final vs initial)	90 days	Yes
Secondary	Blood urea nitrogen	Changes in blood urea nitrogen (final vs initial)	90 days	Yes
Secondary	Creatinine	Changes in creatinine (final vs initial)	90 days	Yes
Secondary	Cholesterol	Changes in cholesterol (final vs initial)	90 days	Yes
Secondary	Triglycerides	Changes in triglycerides (final vs initial)	90 days	Yes
Secondary	Number of acute respiratory infections	Number of acute respiratory infections episodes by supplementation group.	90 days	No