Back to resultsEfficacy of Transfer Factor to Prevent Upper Respiratory Tract Infections in Healthy Adults
Primary Purpose
Upper Respiratory Tract Infections Due to Influenza or Rhinovirus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transfer factor
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Upper Respiratory Tract Infections Due to Influenza or Rhinovirus
Eligibility Criteria
Inclusion Criteria:
- Males and females (18 - 40) who are in good health
Exclusion Criteria:
- Subjects who are allergic to eggs (on which the supplement is based). If a volunteer is not sure if they are allergic to eggs or milk. Those who are currently smoking, have cardiovascular disease, cancer, diabetes, liver disease, renal insufficiency, any chronic disease that might interfere with study participation, BMI above 40 kg/m2, consumption of >12 alcoholic drinks weekly, or unwillingness to stop current supplement intake. Women who are pregnant or lactating will also be excluded from the study.
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Transfer Factor
Sugar pill
Arm Description
Transfer factor supplement; 2 capsules per day
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01106183
Brief Title
Efficacy of Transfer Factor to Prevent Upper Respiratory Tract Infections in Healthy Adults
Official Title
A Double Blind Study on the Efficacy of a Colostrum and Egg Yolk Supplement vs. Placebo to Reduce Frequency and Duration of Upper Respiratory Tract Infections in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goals of our study are to critically evaluate if a healthy population supplemented with Transfer factor experiences fewer incidences of colds and flu, or experience shorter duration of illness compared to an identical population taking placebo. In this study we will give either Transfer factor or a placebo to two groups of healthy adult men and women for a period of 7 weeks in a double-blind experimental design. The frequency and duration of colds and flu-like symptoms will be recorded during the course of the study. Saliva samples will be collected weekly and assessed for salivary IgA secretion rate. Data from this study will establish the efficacy of Transfer Factor to support a healthy immune system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections Due to Influenza or Rhinovirus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transfer Factor
Arm Type
Active Comparator
Arm Description
Transfer factor supplement; 2 capsules per day
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
transfer factor
Intervention Description
capsules, 2 per day by mouth for 7 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
cornstarch, 2 capsules per day by mouth.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females (18 - 40) who are in good health
Exclusion Criteria:
Subjects who are allergic to eggs (on which the supplement is based). If a volunteer is not sure if they are allergic to eggs or milk. Those who are currently smoking, have cardiovascular disease, cancer, diabetes, liver disease, renal insufficiency, any chronic disease that might interfere with study participation, BMI above 40 kg/m2, consumption of >12 alcoholic drinks weekly, or unwillingness to stop current supplement intake. Women who are pregnant or lactating will also be excluded from the study.
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
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Efficacy of Transfer Factor to Prevent Upper Respiratory Tract Infections in Healthy Adults
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