Galactooligosaccharide, Immune Strength, and Digestive Health in Older Adults Over Cold and Flu Season
Completed · Not applicable
Conditions studied: Healthy
In brief
The purpose of this research study is to determine whether a functional fiber, galactooligosaccharide, can help maintain immune strength and digestive health in free-living older adults. It is hypothesized that older adults consuming the fiber daily for 24 weeks over cold and flu season will have more healthy days due to a proliferation of beneficial bacteria within the colon which alters cytokine production and enhances natural killer cell function. Immune and gastrointestinal health will be evaluated via daily questionnaires obtained from 80 participants and from the collection of blood and fecal samples.
Key facts
- Study ID
- NCT01302561
- Run by
- University of Florida
- People needed
- 84
- Starts
- 2010-10-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2012-08-02
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 60 years of age or older
- willing to complete daily and monthly questionnaires
- willing to receive the fall influenza vaccination as part of the study protocol
- willing to provide 3 blood samples, 3 saliva samples, and 2 stool samples and answer a food frequency questionnaire over the course of the study
- 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 study fiber for 24 weeks
- willing to provide a social security number to receive study payment Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided.
- had a cold in the last 12 months
- able to take foods and the study fiber without the aid of another person.
- eligible and willing to receive the influenza vaccine for the current year. That is, you cannot have already received an influenza vaccine for the 2010/2011 season prior to receiving it from the study
You may not qualify if…
- current smoker
- chronic allergies involving the upper respiratory tract (Chronic = taking allergy medicine daily)
- taking any medication for constipation or diarrhea
- currently taking any anti-inflammatory drugs on a regular basis
- currently treated for Alzheimer's disease
- allergy to milk or a serious allergy to eggs (note lactose intolerance should not be a problem because 1 fiber packet contains only 0.3 g of lactose whereas 1 cup of milk contains 12.8 g of lactose)
- currently being treated for any known illnesses or conditions that may impact perceived health such as HIV/AIDS, immune modulating diseases (autoimmune, hepatitis, cancer, etc.), diabetes, kidney disease, gastrointestinal diseases (gastric ulcers, Crohn's, ulcerative colitis, etc.)
- received chemotherapy or other immune suppressing therapy within the last year
- received antibiotic therapy in the past two months
- receiving supplemental oxygen
Where it is running
- University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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