Galactooligosaccharide, Immune Strength, and Digestive Health in Older Adults Over Cold and Flu Season

NCT01302561 | Completed

• 1 other identifier: 355-2010
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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 free-living older adults. It is hypothesized that older adults consuming the fiber daily for 24 weeks over cold and flu season will have more healthy days due to a proliferation of beneficial bacteria within the colon which alters cytokine production and enhances natural killer cell function. Immune and gastrointestinal health will be evaluated via daily questionnaires obtained from 80 participants and from the collection of blood and fecal samples.

Conditions

Healthy

Keywords

adults; fiber; cold; flu; immune function; microbiota

Outcome Measures

Primary Outcomes (1)

• Percentage of days without cold/flu symptoms

  * Average number of cold symptoms \[Nasal Symptoms (Running Nose, Stuffed nose, Blowing the Nose, Yellow Secretion, Bloody Secretion), Pharyngeal Symptoms (Scratchy Throat, Sore Throat, Hoarseness), Bronchial Symptoms (Cough, Secretion, Yellow Secretion), Headache, Achiness (Muscle Pain), Conjunctivitis (Reddish Eyes), Fatigue, Ear Discomfort and Stiffness/Chills\] * Average sum of symptom intensity * Cold symptom score (sum of symptom intensity scores)

  Measured Daily for 24 weeks

Secondary Outcomes (3)

• Digestive Health

  Measured Monthly for 24 weeks

• Immune Function

  Measured at baseline, week 3 and week 5 of the intervention

• Microbiota Study

  Measured at baseline and between weeks 2 and weeks 3 of intervention

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Dietary Supplement: Sucrose

Galactooligosaccharide 5 g

EXPERIMENTAL

Dietary Supplement: Galactooligosaccharide

Interventions

Sucrose DIETARY_SUPPLEMENT

5 g of sucrose twice daily for 24 weeks

Sugar Pill

Galactooligosaccharide DIETARY_SUPPLEMENT

2.5 g galactooligosaccharide plus 2.5 g sucrose twice daily for 24 weeks

Galactooligosaccharide 5 g

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• willing to complete daily and monthly questionnaires
• willing to receive the fall influenza vaccination as part of the study protocol
• willing to provide 3 blood samples, 3 saliva samples, and 2 stool samples and answer a food frequency questionnaire over the course of the study
• 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 study fiber for 24 weeks
• willing to provide a social security number to receive study payment Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided.
• had a cold in the last 12 months
• able to take foods and the study fiber without the aid of another person.
• eligible and willing to receive the influenza vaccine for the current year. That is, you cannot have already received an influenza vaccine for the 2010/2011 season prior to receiving it from the study

You may not qualify if:

• current smoker
• chronic allergies involving the upper respiratory tract (Chronic = taking allergy medicine daily)
• taking any medication for constipation or diarrhea
• currently taking any anti-inflammatory drugs on a regular basis
• currently treated for Alzheimer's disease
• allergy to milk or a serious allergy to eggs (note lactose intolerance should not be a problem because 1 fiber packet contains only 0.3 g of lactose whereas 1 cup of milk contains 12.8 g of lactose)
• currently being treated for any known illnesses or conditions that may impact perceived health such as HIV/AIDS, immune modulating diseases (autoimmune, hepatitis, cancer, etc.), diabetes, kidney disease, gastrointestinal diseases (gastric ulcers, Crohn's, ulcerative colitis, etc.)
• received chemotherapy or other immune suppressing therapy within the last year
• received antibiotic therapy in the past two months
• receiving supplemental oxygen

Sponsors & Collaborators

• University of Florida: lead
• GTC Nutrition: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Common Cold; Influenza, Human

Interventions

Sucrose; 4'-galactooligosaccharide

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

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: February 22, 2011
• First Posted: February 24, 2011
• Study Start: October 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 2, 2012

Record last verified: 2012-07

Locations

US (1)