"Fermented Dairy Beverage on Inflammation/Immune Function in Stressful Exercise" (DAD)
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|ClinicalTrials.gov Identifier: NCT03099044|
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : January 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects||Other: Placebo comparator Other: Single Active dose Other: Double Active dose||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Healthy adults; three groups: Placebo, vs Single-Dose and Double Dose of Fermented Dairy Beverage consumed for 10 days. Subjected to stressful exercise at beginning and end of study. Primary outcomes: immune/inflammatory markers. Assess changes in treatment vs placebo.|
|Masking Description:||Single blind (subjects unaware of treatment identity)|
|Primary Purpose:||Basic Science|
|Official Title:||"Effects of Two Doses of Fermented Dairy Beverage on Inflammation/Immune Function in Healthy Adults Undergoing Stressful Exercise; Compared to a Placebo Beverage"|
|Actual Study Start Date :||February 15, 2017|
|Actual Primary Completion Date :||March 10, 2017|
|Actual Study Completion Date :||July 24, 2017|
Active Comparator: Single Active Dose
Subjects are assigned to receive a single Active beverage and a single placebo beverage.
Other: Single Active dose
Subjects consume 1 placebo + 1 Active beverages daily for 10 days. The dose-response controls for volume consumed.
Active Comparator: Double Active Dose
Subjects are assigned to receive 2 doses of Active beverage.
Other: Double Active dose
Subjects consume 2 Active beverages daily for 10 days. The dose-response controls for volume consumed.
Placebo Comparator: Placebo comparator
Subjects are assigned to receive 2 doses of a placebo beverage.
Other: Placebo comparator
Subjects consume 2 placebo beverages daily for 10 days. The dose-response controls for volume consumed.
- Changes in Inflammatory and immune biomarkers o IL-6, IL-10, IL-1 beta and TNF-alpha [ Time Frame: Days 1 and 10 of study ]
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.
- Ease of consumption (tolerability) of products [ Time Frame: Day 10 of study ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099044
|United States, Missouri|
|QPS Bio-Kinetic Clinical Applications, LLC|
|Springfield, Missouri, United States, 65802|
|Principal Investigator:||Mark R Smith, M.D.||QPS Bio-Kinetic Clinical Applications, LLC|