HealthyGOSNCT01302561
Galactooligosaccharide, Immune Strength, and Digestive Health in Older Adults Over Cold and Flu Season
A study testing Sucrose and Galactooligosaccharide in people with Healthy, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sucrose and Galactooligosaccharide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol 2: Galactooligosaccharide, Immune Strength, and Digestive Health in Older Adults Over Cold and Flu Season
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Sucrose, Galactooligosaccharide
- Keywords
- adults, fiber, cold, flu, immune function, microbiota
- Medical subject headings
- Common Cold, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucroseDietary supplement
5 g of sucrose twice daily for 24 weeks
GalactooligosaccharideDietary supplement
2.5 g galactooligosaccharide plus 2.5 g sucrose twice daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Not described Receives: Dietary Supplement: Sucrose |
| Galactooligosaccharide 5 g | Experimental | Not described Receives: Dietary Supplement: Galactooligosaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of days without cold/flu symptoms
- Average number of cold symptoms [Nasal Symptoms (Running Nose, Stuffed nose, Blowing the Nose, Yellow Secretion, Bloody Secretion), Pharyngeal Symptoms (Scratchy Throat, Sore Throat, Hoarseness), Bronchial Symptoms (Cough, Secretion, Yellow Secretion), Headache, Achiness (Muscle Pain), Conjunctivitis (Reddish Eyes), Fatigue, Ear Discomfort and Stiffness/Chills]
- Average sum of symptom intensity
- Cold symptom score (sum of symptom intensity scores)
Measured: Measured Daily for 24 weeks
Secondary outcomes (3)
Digestive Health
- Symptoms (gas, bloating, diarrhea, etc.)
- Bowel habits (bowel movement frequency and consistency)
Measured: Measured Monthly for 24 weeks
Immune Function
- Leukocyte phenotype and function
- Peripheral blood mononuclear cell cytokine production to mitogens
- Serum acute phase proteins, cytokines, endotoxin, and immunoglobulin
- Salivary and fecal sIgA
Measured: Measured at baseline, week 3 and week 5 of the intervention
Microbiota Study
- Microbial diversity measured by DGGE profiling (detect large distortions)
- qPCR to quantify changes in Lactic Acid Bacteria and Bifidobacteria (beneficial changes)
- 16S rRNA sequencing (454) to identify treatment effects on specific bacteria
Measured: Measured at baseline and between weeks 2 and weeks 3 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- GTC Nutrition
- Responsible party
- Sponsor
- Investigators
- Bobbi Langkamp-Henken, PhD, RD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302561
- Sponsor's protocol ID
- 355-2010
- Acronym
- GOS
- Status last verified
- Jul 2012
- First submitted
- 22 Feb 2011
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol 2: Galactooligosaccharide, Immune Strength, and Digestive Health in Older Adults Over Cold and Flu Season
- ClinicalTrials.gov ID
- NCT01302561
- Acronym / sponsor ID
- GOS / 355-2010
- Conditions
- Healthy
- Keywords
- adults, fiber, cold, flu, immune function, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- GTC Nutrition
- Study start
- Oct 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Dietary Supplement: Sucrose |
| Galactooligosaccharide 5 g | Experimental | Dietary Supplement: Galactooligosaccharide |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sucrose5 g of sucrose twice daily for 24 weeks | Dietary supplement | Sugar Pill |
| Galactooligosaccharide2.5 g galactooligosaccharide plus 2.5 g sucrose twice daily for 24 weeks | Dietary supplement | Galactooligosaccharide 5 g |
Primary outcome
Percentage of days without cold/flu symptoms
Time frame: Measured Daily for 24 weeks
* Average number of cold symptoms [Nasal Symptoms (Running Nose, Stuffed nose, Blowing the Nose, Yellow Secretion, Bloody Secretion), Pharyngeal Symptoms (Scratchy Throat, Sore Throat, Hoarseness), Bronchial Symptoms (Cough, Secretion, Yellow Secretion), Headache, Achiness (Muscle Pain), Conjunctivitis (Reddish Eyes), Fatigue, Ear Discomfort and Stiffness/Chills] * Average sum of symptom intensity * Cold symptom score (sum of symptom intensity scores)
3 secondary outcomes
Digestive Health
Time frame: Measured Monthly for 24 weeks
Immune Function
Time frame: Measured at baseline, week 3 and week 5 of the intervention
Microbiota Study
Time frame: Measured at baseline and between weeks 2 and weeks 3 of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bobbi Langkamp-Henken, PhD, RD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucrose and Galactooligosaccharide in people with Healthy, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of days without cold/flu symptoms (time frame: Measured Daily for 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.