The effect of Glycomax 'Trademark' lactoferrin and bovine whey immunoglobulin-rich fraction on gene expression patterns in healthy adults: a double-blind placebo-controlled randomised clinical trial

Phase 4

Completed

• Conditions: Immune Function in Healthy Adults; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12614000462684
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

For inclusion into the study, participants are required to be:
aged between 18-55 years;
in current good health;
have Body Mass Index (BMI) <30 kg/m2

Exclusion Criteria

Participants will be excluded from participation if they:
are lactose intolerant;
consume of fish oil, probiotics, prebiotics, whey protein supplements during the trial period;
require insulin use (for treatment of diabetes);
have a history of liver, kidney or thyroid disease;
use anti-inflammatory or immune-modulating medications; have heavy alcohol consumption (according to the CDC definitions);
are pregnant or intending to become pregnant during the trial period;
have had high level of radiation exposure over the preceding 12 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in whole genome gene expression patterns (determined using expression arrays) in response to the intervention.[Intervention period is 28 days.<br>Primary endpoints will be determined at day 28.]

Secondary Outcome Measures

Name	Time	Method
Self-reported illness symptoms reported via the Wisconsin Upper Respiratory Symptom Survey-11[Day 28]