Clinical trial NCT01137760: Galactooligosaccharide, Immune Strength, and Digestive Health
Official title: Protocol 1: Galactooligosaccharide, Immune Strength, and Digestive Health in Academically Stressed University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: adults
fiber
cold
flu
stress
microbiota
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: GTC Nutrition
First posted: 2010-06-04
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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 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)

Primary outcomes:
measure: Days without cold/flu symptoms
timeFrame: Measured daily for 8 weeks
Secondary outcomes:
measure: Gastrointestinal symptoms
timeFrame: Measured weekly for 8 weeks
measure: Changes in overall microbiota diversity
timeFrame: Measured at baseline and approximately week 4
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Bobbi Langkamp-Henken, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.