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Galactooligosaccharide, Immune Strength, and Digestive Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01137760
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : August 2, 2012
GTC Nutrition
Information provided by (Responsible Party):
University of Florida

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 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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Sucrose Dietary Supplement: Galactooligosaccharide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 427 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Protocol 1: Galactooligosaccharide, Immune Strength, and Digestive Health in Academically Stressed University Students
Study Start Date : October 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
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

Experimental: Galactooligosaccharide 5.0 g Dietary Supplement: Galactooligosaccharide
5.0 g galactooligosaccharide daily for 8 weeks

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01137760

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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611-0370
Sponsors and Collaborators
University of Florida
GTC Nutrition
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Principal Investigator: Bobbi Langkamp-Henken, PhD, RD University of Florida

Publications of Results:
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Responsible Party: University of Florida Identifier: NCT01137760     History of Changes
Other Study ID Numbers: 307-2009
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: July 2012

Keywords provided by University of Florida: