Status:
COMPLETED
Galactooligosaccharide, Immune Strength, and Digestive Health
Lead Sponsor:
University of Florida
Collaborating Sponsors:
GTC Nutrition
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to determine whether a functional fiber, galactooligosaccharide, can help maintain immune strength and digestive health in undergraduate students who are undergoi...
Detailed Description
A prospective, randomized, parallel, double-blind, placebo controlled design will be used. Healthy full-time undergraduate students undergoing fall 2009 final academic exams will be recruited from the...
Eligibility Criteria
Inclusion
- 18 years of age or older
- willing to complete a daily assessment form via computer
- willing to discontinue any immune-enhancing dietary supplements ( e.g., prebiotics and fiber supplements, probiotics, echinacea, fish oil, vitamin E \>100% of the RDA or \>15 mg/day)
- willing to take the fiber for 8 weeks
- had a cold in last 12 months
- have at least 1 final during the Fall 2009 exam week, between Saturday, December 12 and Friday, December18, 2009
- daily access to a computer with Internet access for the entire 8-wk study
Exclusion
- current smoker
- chronic allergies involving the upper respiratory tract (Chronic = taking allergy medicine daily)
- an allergy to milk
- known illnesses or conditions that may impact perceived health such as HIV/AIDS, diabetes, renal or gastrointestinal diseases
- received chemotherapy or other immune suppressing therapy within the last year
- antibiotic therapy in the past two months
- a cold or cold symptoms (on day of randomization)
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT01137760
Start Date
October 1 2009
End Date
January 1 2010
Last Update
August 2 2012
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32611-0370