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

NCT03099044 | Completed

• 1 other identifier: 69716
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• 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.

  Days 1 and 10 of study

Secondary Outcomes (1)

• Ease of consumption (tolerability) of products

  Day 10 of study

Study Arms (3)

Single Active Dose

ACTIVE COMPARATOR

Subjects are assigned to receive a single Active beverage and a single placebo beverage.

Other: Single Active dose

Double Active Dose

ACTIVE COMPARATOR

Subjects are assigned to receive 2 doses of Active beverage.

Other: Double Active dose

Placebo comparator

PLACEBO COMPARATOR

Subjects are assigned to receive 2 doses of a placebo beverage.

Other: Placebo comparator

Interventions

Placebo comparator OTHER

Subjects consume 2 placebo beverages daily for 10 days. The dose-response controls for volume consumed.

Placebo comparator

Single Active dose OTHER

Subjects consume 1 placebo + 1 Active beverages daily for 10 days. The dose-response controls for volume consumed.

Single Active Dose

Double Active dose OTHER

Subjects consume 2 Active beverages daily for 10 days. The dose-response controls for volume consumed.

Double Active Dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. Subject has a history of cancer (except localized skin cancer without metastases) within five years prior to screening.
• \. 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.
• \. 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.
• \. Subject who is currently taking or has taken probiotics within 30 days prior to the baseline visit.
• \. 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.
• \. 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.
• \. Subject has a known or suspected allergy or hypersensitivity to trial product(s), including lactose intolerance and or dairy allergies or related product(s).
• \. 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.
• \. Abnormal electrocardiogram (ECG) results thought to be potentially clinically significant according to the Investigator, or QT prolongation, as evidenced by QTcF \>450 msec.
• \. Subject has a recent history (within 12 months of Screening) of substance or alcohol abuse.
• \. Subject has taken an investigational product within 30 days of study enrollment (Visit 1).
• \. 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).

Sponsors & Collaborators

• Dairy A Day, Inc.: lead

Study Sites (1)

QPS Bio-Kinetic Clinical Applications, LLC

Springfield, Missouri, 65802, United States

Location

Study Officials

• Mark R Smith, M.D.

  QPS Bio-Kinetic Clinical Applications, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blind (subjects unaware of treatment identity)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: April 4, 2017
• Study Start: February 15, 2017
• Primary Completion: March 10, 2017
• Study Completion: July 24, 2017
• Last Updated: January 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)