Galactooligosaccharide, Immune Strength, and Digestive Health

August 1, 2012 updated by: University of Florida

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
427

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611-0370
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Sugar pill
Dietary supplement: Sucrose
5 g of sucrose daily for 8 weeks
Experimental: Galactooligosaccharide 2.5 g
Dietary supplement: Galactooligosaccharide
2.5 g galactooligosaccharide plus 2.5 g sucrose daily for 8 weeks
Dietary supplement: Galactooligosaccharide
5.0 g galactooligosaccharide daily for 8 weeks
Experimental: Galactooligosaccharide 5.0 g
Dietary supplement: Galactooligosaccharide
2.5 g galactooligosaccharide plus 2.5 g sucrose daily for 8 weeks
Dietary supplement: Galactooligosaccharide
5.0 g galactooligosaccharide daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Measured daily for 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gastrointestinal symptoms
Time Frame: Measured weekly for 8 weeks
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 weekly for 8 weeks
Changes in overall microbiota diversity
Time Frame: Measured at baseline and approximately week 4
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 at baseline and approximately week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GTC Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 307-2009

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