"Fermented Dairy Beverage on Inflammation/Immune Function in Stressful Exercise"



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:1/7/2018
Start Date:February 15, 2017
End Date:July 24, 2017

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"Effects of Two Doses of Fermented Dairy Beverage on Inflammation/Immune Function in Healthy Adults Undergoing Stressful Exercise; Compared to a Placebo Beverage"

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.

Inclusion Criteria:

- 1. Males, aged 18 to 50 years of age (inclusive) at the time of screening, nonsmokers
for at least 10 years at the time of screening and throughout the study.

2. BMI between 20.0 and 34.9 kg/m2 (inclusive) at the time of screening. 3. Subject is
currently exercising less than 150 minutes per week. 4. Subject is in good health and
appropriate for exercise as determined by physical examination, medical history,
laboratory tests, cardiac monitoring and Physical Activity Readiness Questionnaire
(PAR-Q) 5. Subjects must be able to understand the study, agree to the requirements
and restrictions, and be willing to give voluntary consent to participate in the
study.

6. Subject states that he is able to jog, run and/or walk on a treadmill for 60
minutes.

Exclusion Criteria:

- 1. History of any clinically significant cardiovascular (e.g., blocked coronary artery
disease, hypertension, hyperlipidemia, Wolff-Parkinson-White syndrome, etc.),
respiratory, endocrine (e.g., diabetes I or II, etc.), renal, hepatic,
gastrointestinal, hematologic, neurologic, psychiatric, connective tissue (e.g.,
Marfan syndrome, etc.) disease or disorder, or any uncontrolled medical illness which
in the opinion of the Investigator would jeopardize the safety of the subject,
interfere with study assessments, or impact the validity of the study results.

2. Family history of any first degree relative (mother, father, sibling, child) with
myocardial infarction before age 50 or any first degree relative with sudden,
unexplained cardiac death.

3. Subject with a positive result for or history of positive test result(s) for human
immunodeficiency virus (HIV) antibody, Hepatitis B surface antigen or Hepatitis C
antibody.

4. Subject has a history of cancer (except localized skin cancer without metastases)
within five years prior to screening.

5. Subject has any current orthopedic problem(s) or clinically significant history of
musculoskeletal injury(ies) of the legs that the PI feels may interfere with the study
exercise.

6. Subjects who are not deemed as healthy by standard physical, medical history and
other means of screen testing (vitals, blood work, etc.) per PI review and discretion.

7. Subject who is currently taking or has taken probiotics within 30 days prior to the
baseline visit.

8. Subjects who ingests yogurt (regular, Greek or Icelandic), Kefir or any fermented
dairy products four or more times per week regularly within the month prior to
baseline visit.

9. Subject who regularly consumes fermented beverages, such as Kombucha. Regular is
defined as more than twice per week and for more than two-weeks consistently, within
the 3 months prior to baseline visit.

10. Subject has a known or suspected allergy or hypersensitivity to trial product(s),
including lactose intolerance and or dairy allergies or related product(s).

11. Subject exhibits evidence of hepatic or renal dysfunction as evidenced by ALT or
AST being ≥ 2 times the upper limit of normal or serum creatinine value ≥ 2.0 mg/dl or
other clinically significant abnormal clinical laboratory value per PI discretion.

12. Abnormal electrocardiogram (ECG) results thought to be potentially clinically
significant according to the Investigator, or QT prolongation, as evidenced by QTcF
>450 msec.

13. Subject has a recent history (within 12 months of Screening) of substance or
alcohol abuse.

14. Subject has taken an investigational product within 30 days of study enrollment
(Visit 1).

15. Subject who is currently taking any concomitant medications, including
prescription or over the counter (OTC), herbal or dietary supplements, vitamin and/or
mineral supplements, or NSAIDS or any other anti-inflammatory products, from 7 days
prior to baseline and throughout the study (other than study products).
We found this trial at
1
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Springfield, Missouri 65802
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Springfield, MO
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