Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT01302561
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01302561
Study Brief:
Protocol Section:
NCT01302561