The purpose of this pilot study is to determine the effects of a Single and Double Dose of Fermented Dairy Beverage on immune health and inflammatory status in healthy adults undergoing stressful exercise.
This is a "pilot" study. A total of 45 male subjects will be randomized to receive either Active product (in 2 doses) or placebo. This is a single-blind design (subjects are unaware of product type they are receiving). Randomization is in a 1:1:1 ratio for active test product (in different doses) versus placebo. Products will consume the beverages for a 10-day period. The subjects will be subjected to a defined strenuous exercise protocol on Days 1 and 10 of the study. Blood will be collected on the exercise days (pre- and post-exercise) on Days 1 and 10. Blood will be analyzed for markers of Immunity and Inflammation, to assess the immuno-supportive and anti-inflammatory properties of the Active product. Product acceptance and tolerability will also be assessed using a VAS scale. Outcome analysis will be based upon changes over time (from time-point 0) for within group changes as well as between group differences. That is, study will examine differences in end-points from baseline to end-of-study; as well as differences among the three groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
45
Subjects consume 2 placebo beverages daily for 10 days. The dose-response controls for volume consumed.
Subjects consume 1 placebo + 1 Active beverages daily for 10 days. The dose-response controls for volume consumed.
Subjects consume 2 Active beverages daily for 10 days. The dose-response controls for volume consumed.
QPS Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, United States
Changes in Inflammatory and immune biomarkers o IL-6, IL-10, IL-1 beta and TNF-alpha
IL-6, IL-10, IL-1 beta and TNF-alpha; IgA, IgG, IgM, absolute neutrophil count, absolute lymphocytes, absolute monocytes, and other immune cells. As there are multiple variables, statistical Outcome analysis for "within and between group differences" will be based upon changes over time (from time-point 0) for within group changes \[in each outcome measure\] as well as between group differences. P value for significance is set at P\< 0.05 for significance and will include 95% Confidence Intervals where appropriate. As this is a pilot study, no corrective factors for multiple sets of analysis will be employed.
Time frame: Days 1 and 10 of study
Ease of consumption (tolerability) of products
Product ease of consumption (tolerability) will be measured by a Visual Analog Scale. On the VAS scale of 1-10, each subject is asked: "How would you rate your tolerability, your acceptance of this product?" This will be done to compare tolerability of the two product types.
Time frame: Day 10 of study
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