NCT01137760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
427

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

3 months

First QC Date

June 3, 2010

Last Update Submit

August 1, 2012

Conditions

Healthy

Keywords

adultsfibercoldflustressmicrobiota

Outcome Measures

Primary Outcomes (1)

  • 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 daily for 8 weeks

Secondary Outcomes (2)

  • Gastrointestinal symptoms

    Measured weekly for 8 weeks

  • Changes in overall microbiota diversity

    Measured at baseline and approximately week 4

Study Arms (3)

Sugar pill

PLACEBO COMPARATOR
Dietary Supplement: Sucrose

Galactooligosaccharide 2.5 g

EXPERIMENTAL
Dietary Supplement: Galactooligosaccharide

Galactooligosaccharide 5.0 g

EXPERIMENTAL
Dietary Supplement: Galactooligosaccharide

Interventions

SucroseDIETARY_SUPPLEMENT

5 g of sucrose daily for 8 weeks

Sugar pill
GalactooligosaccharideDIETARY_SUPPLEMENT

2.5 g galactooligosaccharide plus 2.5 g sucrose daily for 8 weeks

Galactooligosaccharide 2.5 g

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611-0370, United States

Location

Related Publications (1)

  • 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.

    PMID: 21525194RESULT

MeSH Terms

Conditions

Common ColdInfluenza, Human

Interventions

Sucrose4'-galactooligosaccharide

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesOrthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Bobbi Langkamp-Henken, PhD, RD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2010

First Posted

June 4, 2010

Study Start

October 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 2, 2012

Record last verified: 2012-07

Locations

US(1)