HealthyNCT01137760
Galactooligosaccharide, Immune Strength, and Digestive Health
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 undergraduate students who are undergoing an academic stress (i.e., final exams). Read more about this study
- Who is it for?
- Ages 18 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
- 427 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jan 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida
Gainesville, Florida, 32611-0370
About this study
Official title: Protocol 1: Galactooligosaccharide, Immune Strength, and Digestive Health in Academically Stressed University Students
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 undergoing an academic stress (i.e., final exams). Subjects will be asked to consume the fiber or placebo each day for eight weeks. Immune and gastrointestinal health will be evaluated via daily questionnaires obtained from 420 students and from the collection of fecal samples in a subgroup of students.
Read the 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 University of Florida. Informed consent will be obtained. All subjects will be consented for the main intervention study and a subgroup (n=25/group or 75 total) of these subjects will also be consented to provide two stool samples at baseline and two stool samples during the week of final exams (approximately week 4 of the intervention). Subjects will be stratified based on gender and randomized (n=140/group) to receive 0 g, 2.5 g, or 5.0 g of the fermentable fiber, galactooligosaccharides, for eight weeks around the time of their fall final exams. Subjects will complete daily online questionnaires asking whether they are experiencing any cold/flu symptoms. Weekly online questionnaires will collect information regarding gastrointestinal symptoms over the past week. The acute psychological stress associated with final exams will increase cold/flu symptoms. It is anticipated that students consuming the galactooligosaccharides versus the placebo will have more healthy days (i.e., days without cold symptoms) due to fiber induced changes in the beneficial bacteria within the colon, which reduces the burden on the immune system.
- Conditions
- Healthy
- Being tested
- Sucrose, Galactooligosaccharide
- Keywords
- adults, fiber, cold, flu, stress, 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 daily for 8 weeks
GalactooligosaccharideDietary supplement
2.5 g galactooligosaccharide plus 2.5 g sucrose daily for 8 weeks
GalactooligosaccharideDietary supplement
5.0 g galactooligosaccharide daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | Not described Receives: Dietary Supplement: Sucrose |
| Galactooligosaccharide 2.5 g | Experimental | Not described Receives: Dietary Supplement: Galactooligosaccharide |
| Galactooligosaccharide 5.0 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.
Days without cold/flu symptoms
Number of cold/flu symptoms (running/congested nose, stiffness or chills, headache, cough, fatigue, fever, sore throat, achiness, ear discomfort), Intensity of cold/flu symptoms
Measured: Measured daily for 8 weeks
Secondary outcomes (2)
Gastrointestinal symptoms
diarrhea, loose stools, urgent need for defecation, rumbling, bloating, burping, gas, constipation, hard stools, feeling of incomplete evacuation, abdominal pain, hunger pains, nausea, heartburn, acid regurgitation
Measured: Measured weekly for 8 weeks
Changes in overall microbiota diversity
Stool collections will be obtained from a subgroup of subjects (n=25/group or 75 total). Samples will be provided at baseline (i.e., before the start of the intervention)and during the week of final exams (i.e., approximately study week 4).
Measured: Measured at baseline and approximately week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 427 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
- NCT01137760
- Sponsor's protocol ID
- 307-2009
- Status last verified
- Jul 2012
- First submitted
- 3 Jun 2010
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hughes C, Davoodi-Semiromi Y, Colee JC, Culpepper T, Dahl WJ, Mai V, Christman MC, Langkamp-Henken B. Galactooligosaccharide supplementation reduces stress-induced gastrointestinal dysfunction and days of cold or flu: a randomized, double-blind, controlled trial in healthy university students. Am J Clin Nutr. 2011 Jun;93(6):1305-11. doi: 10.3945/ajcn.111.014126. Epub 2011 Apr 27.
PubMed 21525194
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 1: Galactooligosaccharide, Immune Strength, and Digestive Health in Academically Stressed University Students
- ClinicalTrials.gov ID
- NCT01137760
- Acronym / sponsor ID
- 307-2009
- Conditions
- Healthy
- Keywords
- adults, fiber, cold, flu, stress, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- GTC Nutrition
- Study start
- Oct 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 4 Jun 2010 (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 undergraduate students who are undergoing an academic stress (i.e., final exams). Subjects will be asked to consume the fiber or placebo each day for eight weeks. Immune and gastrointestinal health will be evaluated via daily questionnaires obtained from 420 students and from the collection of fecal samples in a subgroup of students.
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 University of Florida. Informed consent will be obtained. All subjects will be consented for the main intervention study and a subgroup (n=25/group or 75 total) of these subjects will also be consented to provide two stool samples at baseline and two stool samples during the week of final exams (approximately week 4 of the intervention). Subjects will be stratified based on gender and randomized (n=140/group) to receive 0 g, 2.5 g, or 5.0 g of the fermentable fiber, galactooligosaccharides, for eight weeks around the time of their fall final exams. Subjects will complete daily online questionnaires asking whether they are experiencing any cold/flu symptoms. Weekly online questionnaires will collect information regarding gastrointestinal symptoms over the past week. The acute psychological stress associated with final exams will increase cold/flu symptoms. It is anticipated that students consuming the galactooligosaccharides versus the placebo will have more healthy days (i.e., days without cold symptoms) due to fiber induced changes in the beneficial bacteria within the colon, which reduces the burden on the immune system.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Dietary Supplement: Sucrose |
| Galactooligosaccharide 2.5 g | Experimental | Dietary Supplement: Galactooligosaccharide |
| Galactooligosaccharide 5.0 g | Experimental | Dietary Supplement: Galactooligosaccharide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 daily for 8 weeks | Dietary supplement | Sugar pill |
| Galactooligosaccharide2.5 g galactooligosaccharide plus 2.5 g sucrose daily for 8 weeks | Dietary supplement | Galactooligosaccharide 2.5 g |
| Galactooligosaccharide5.0 g galactooligosaccharide daily for 8 weeks | Dietary supplement | Galactooligosaccharide 5.0 g |
Primary outcome
Days without cold/flu symptoms
Time frame: Measured daily for 8 weeks
Number of cold/flu symptoms (running/congested nose, stiffness or chills, headache, cough, fatigue, fever, sore throat, achiness, ear discomfort), Intensity of cold/flu symptoms
2 secondary outcomes
Gastrointestinal symptoms
Time frame: Measured weekly for 8 weeks
Changes in overall microbiota diversity
Time frame: Measured at baseline and approximately week 4
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.
- Results publication: PubMed 21525194Hughes C, Davoodi-Semiromi Y, Colee JC, Culpepper T, Dahl WJ, Mai V, Christman MC, Langkamp-Henken B. Galactooligosaccharide supplementation reduces stress-induced gastrointestinal dysfunction and days of cold or flu: a randomized, double-blind, controlled trial in healthy university students. Am J Clin Nutr. 2011 Jun;93(6):1305-11. doi: 10.3945/ajcn.111.014126. Epub 2011 Apr 27.
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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 7 inclusion and 7 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?
Days without cold/flu symptoms (time frame: Measured daily for 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01137760, which also lists 1 linked publication.
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.