Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT01302561
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2011-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Galactooligosaccharide, Immune Strength, and Digestive Health in Older Adults Over Cold and Flu Season
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Protocol 2: Galactooligosaccharide, Immune Strength, and Digestive Health in Older Adults Over Cold and Flu Season
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GOS
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 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.
Detailed Description:
A prospective, randomized, parallel, double-blind, placebo controlled trial will be used. Healthy older adults will be recruited from the Gainesville area via direct mailing, flyers, list servs, presentations to clubs/organizations/church groups, social networks, etc. Informed consent will be obtained and once the informed consent is signed the inclusion/exclusion form will be reviewed to determine whether a subject qualifies for the study.
Prior to randomization, height, weight, age, and a stool sample will be obtained. On the day of randomization, blood will be drawn and saliva will be collected for baseline immune function studies from all subjects who qualify based on the final criteria (i.e., cannot have a cold on the day of randomization).
Subjects will be stratified based on body mass index and age and randomized via sealed envelope to the treatment (5 g GOS) or placebo groups (n=40/group). The fiber will be provided in small packets containing 2.5 g of fiber and 2.5 g sucrose (treatment) or 5 g of sucrose (placebo). Subjects will be instructed to add the contents of the packet to coffee, tea, water, milk, or other non-carbonated drink, hot cereal or pudding and mix well. Subjects will be told to consume two packets per day and maintain a daily study log. The daily questionnaire will ask about intake of the fiber, cold symptoms, and general health (i.e., new medications, doctor visits).
Between weeks two and three of the intervention, a second stool sample will be obtained. After three weeks of the intervention, subjects will receive the influenza vaccination and blood and saliva will be collected for immune function studies. Two weeks postvaccination (i.e., 5 weeks of intervention), blood and saliva will be collected for immune function studies. Subjects will continue the intervention and maintain daily logs for a total of 24 weeks. Subjects will also be asked to complete a questionnaire on a monthly basis regarding gastrointestinal symptoms and typical level of exercise.
Prior to randomization, height, weight, age, and a stool sample will be obtained. On the day of randomization, blood will be drawn and saliva will be collected for baseline immune function studies from all subjects who qualify based on the final criteria (i.e., cannot have a cold on the day of randomization).
Subjects will be stratified based on body mass index and age and randomized via sealed envelope to the treatment (5 g GOS) or placebo groups (n=40/group). The fiber will be provided in small packets containing 2.5 g of fiber and 2.5 g sucrose (treatment) or 5 g of sucrose (placebo). Subjects will be instructed to add the contents of the packet to coffee, tea, water, milk, or other non-carbonated drink, hot cereal or pudding and mix well. Subjects will be told to consume two packets per day and maintain a daily study log. The daily questionnaire will ask about intake of the fiber, cold symptoms, and general health (i.e., new medications, doctor visits).
Between weeks two and three of the intervention, a second stool sample will be obtained. After three weeks of the intervention, subjects will receive the influenza vaccination and blood and saliva will be collected for immune function studies. Two weeks postvaccination (i.e., 5 weeks of intervention), blood and saliva will be collected for immune function studies. Subjects will continue the intervention and maintain daily logs for a total of 24 weeks. Subjects will also be asked to complete a questionnaire on a monthly basis regarding gastrointestinal symptoms and typical level of exercise.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: