Healthy SubjectsDADNCT03099044

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

A study testing Single Active dose and Double Active dose in people with Healthy Subjects, run by Dairy A Day, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Single Active dose and Double Active dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteUnited States
Study dates: 15 Feb 2017to 24 Jul 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 15Show fewer

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

QPS Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, 65802

Other trials in United States

About this study

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"

Read the detailed description

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.

Conditions: Healthy Subjects
Being tested: Placebo comparator, Single Active dose, Double Active dose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo comparatorOther
Subjects consume 2 placebo beverages daily for 10 days. The dose-response controls for volume consumed.
Single Active doseOther
Subjects consume 1 placebo + 1 Active beverages daily for 10 days. The dose-response controls for volume consumed.
Double Active doseOther
Subjects consume 2 Active beverages daily for 10 days. The dose-response controls for volume consumed.

Study groups in NCT03099044
Study group	Role	What they receive
Single Active Dose	Active comparator	Subjects are assigned to receive a single Active beverage and a single placebo beverage. Receives: Other: Single Active dose
Double Active Dose	Active comparator	Subjects are assigned to receive 2 doses of Active beverage. Receives: Other: Double Active dose
Placebo comparator	Placebo comparator	Subjects are assigned to receive 2 doses of a placebo beverage. Receives: Other: Placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Days 1 and 10 of study

Secondary outcomes (1)

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.
Measured: Day 10 of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201724 Jul 2017

First posted4 Apr 2017
Study start15 Feb 2017
Primary completion10 Mar 2017
Study completion24 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
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: Single blind
Who is masked: Investigator
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03099044
Sponsor's protocol ID: 69716
Acronym: DAD
Status last verified: Jan 2018
First submitted: 15 Mar 2017
Last updated: 5 Jan 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is no such plan.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Not yet recruiting
ACUTE EFFECTS OF HIGH-INTENSITY LASER THERAPY ON PAIN, MUSCLE STIFFNESS, AND GRIP STRENGTH IN HEALTHY ADULTS
Exercise-Induced Muscle Fatigue, Fatigue Recovery
RecruitingObservational study
Defining the Brain Phenotype of Children With Williams Syndrome
Williams Syndrome, Duplication

All Healthy Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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"
ClinicalTrials.gov ID: NCT03099044
Acronym / sponsor ID: DAD / 69716
Conditions: Healthy Subjects
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Dairy A Day, Inc.Industry (pharma, biotech, devices)
Study start: 15 Feb 2017 (actual)
Primary completion: 10 Mar 2017 (actual)
Study completion: 24 Jul 2017 (actual)
First posted: 4 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3
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.

Arm	Type	Receives
Single Active Dose	Active comparator	Other: Single Active doseSubjects are assigned to receive a single Active beverage and a single placebo beverage.
Double Active Dose	Active comparator	Other: Double Active doseSubjects are assigned to receive 2 doses of Active beverage.
Placebo comparator	Placebo comparator	Other: Placebo comparatorSubjects are assigned to receive 2 doses of a placebo beverage.

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo comparatorSubjects consume 2 placebo beverages daily for 10 days. The dose-response controls for volume consumed.	Other	Placebo comparator
Single Active doseSubjects consume 1 placebo + 1 Active beverages daily for 10 days. The dose-response controls for volume consumed.	Other	Single Active Dose
Double Active doseSubjects consume 2 Active beverages daily for 10 days. The dose-response controls for volume consumed.	Other	Double Active Dose

Primary outcome

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.

1 secondary outcome

Ease of consumption (tolerability) of products
Time frame: Day 10 of study

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
Individual participant dataSharing planned: No. There is no such plan.

Related trials for Healthy Subjects

Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Not yet recruiting
ACUTE EFFECTS OF HIGH-INTENSITY LASER THERAPY ON PAIN, MUSCLE STIFFNESS, AND GRIP STRENGTH IN HEALTHY ADULTS
Exercise-Induced Muscle Fatigue, Fatigue Recovery
RecruitingObservational study
Defining the Brain Phenotype of Children With Williams Syndrome
Williams Syndrome, Duplication

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark R Smith, M.D. principal investigator

QPS Bio-Kinetic Clinical Applications, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Single Active dose and Double Active dose in people with Healthy Subjects, run by Dairy A Day, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03099044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.