Galactooligosaccharide, Immune Strength, and Digestive Health

This study has been completed.
Sponsor:
Collaborator:
GTC Nutrition
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01137760
First received: June 3, 2010
Last updated: August 1, 2012
Last verified: July 2012
  Purpose

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 Intervention
Healthy
Dietary Supplement: Sucrose
Dietary Supplement: Galactooligosaccharide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Protocol 1: Galactooligosaccharide, Immune Strength, and Digestive Health in Academically Stressed University Students

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Days without cold/flu symptoms [ Time Frame: Measured daily for 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Gastrointestinal symptoms [ Time Frame: Measured weekly for 8 weeks ] [ Designated as safety issue: No ]
    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

  • Changes in overall microbiota diversity [ Time Frame: Measured at baseline and approximately week 4 ] [ Designated as safety issue: No ]
    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).


Enrollment: 427
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137760

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

Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01137760     History of Changes
Other Study ID Numbers: 307-2009
Study First Received: June 3, 2010
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
adults
fiber
cold
flu
stress
microbiota

ClinicalTrials.gov processed this record on July 20, 2014