- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04427020
Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding
June 8, 2020 updated by: Lindenwood University
The purpose of this study is to examine the pharmacokinetic pattern of amino acid absorption after a two-week pattern of milk protein supplementation with and without the addition of Bacillus coagulans GBI-30, 6086.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will be conducted using a randomized, double-blind, crossover study design.
30 healthy men and women between the ages of 18 - 55 years of age will be recruited to participate in this study.
Prior to beginning the study, all participants will sign an IRB-approved informed consent document and complete a healthy history questionnaire to determine study eligibility.
Two supplementation protocols that each span two weeks will be completed and separated with a washout period of three weeks.
For each study visit, all participants will report to the laboratory between 0600 - 1000 hours after observing an 8 - 10-hour fast.
For two weeks prior to each study visit, participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a milk protein concentrate or a similar dose of milk protein concentrate plus bacillus coagulans GBI-30, 6086.
Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured using bioelectrical impedance analysis (BIA).
Upon ingestion of their final assigned supplementation dose, standard multiple sample phlebotomy approaches will used to collect approximately 10mL of venous blood from a forearm vein before (0 min), 30, 60, 90, 120, 180, and 240 minutes after ingestion of their final assigned supplementation dose for that period in the study protocol.
Participants will be provided 200 mL of cold water to ingest after each blood collection.
Upon processing, all blood samples will be stored at -80 C. All samples will o be discarded according to Institutional Review Board-stipulated guidelines.
Study participants will be provided an additional two-week supply of the alternative treatment to begin after observing a three-week washout.
After two weeks of supplementation, study participants will return to the laboratory for their remaining testing visit.
All subsequent study visits will be completed in a randomized fashion to minimize any order effects from testing.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Charles, Missouri, United States, 63301
- Lindenwood University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All participants will be between the ages of 18-55 years.
- Participants will be healthy and free of disease as determined by evaluation of a medical history.
- Completing at least 30 minutes of moderate exercise three days per week
Exclusion Criteria:
- Those individuals less than 18 and greater than 55 years of age will be excluded.
- Any individual who is currently being treated for or diagnosed with a cardiac disorder or disease
- Any individual who is currently being treated for or diagnosed with a respiratory disorder or disease
- Any individual who is currently being treated for or diagnosed with a circulatory disorder or disease
- Any individual who is currently being treated for or diagnosed with a musculoskeletal disorder or disease
- Any individual who is currently being treated for or diagnosed with a metabolic disorder or disease
- Any individual who is currently being treated for or diagnosed with obesity (defined as body mass index > 30 kg/m and body fat greater than 30%)
- Any individual who is currently being treated for or diagnosed with an immune or autoimmune disorder or disease
- Any individual who is currently being treated for or diagnosed with a psychiatric disorder or disease
- Any individual who is currently being treated for or diagnosed with a hematological disorder or disease
- Any individual who is currently being treated for or diagnosed with a neurological disorder or disease
- Any individual who is currently being treated for or diagnosed with an endocrinological disorder or disease
- Participants who are determined to not be weight stable defined as measured body mass deviating by 2% or more.
- Participants who do not or are not willing to abstain from alcohol, nicotine, and caffeine for 12 hours prior to each visit will be excluded
- Participants who do not or are not willing to abstain from exercise for 12 hours prior to each visit will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Milk Protein + Probiotic
25 gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086
|
Both conditions matched flavor, color, and serving size
|
Active Comparator: Milk Protein
25 gram dose of milk protein concentrate
|
Both conditions matched flavor, color, and serving size
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of amino acid absorption
Time Frame: seven weeks
|
We intend to determine if the addition of a probiotic to milk protein ingestion changes the rate (in minutes) to which amino acids are absorbed into our bloodstream.
|
seven weeks
|
Concentration of amino acid absorption
Time Frame: seven weeks
|
We intend to determine if the addition of a probiotic to milk protein ingestion changes the extent (concentration in millimoles/Liter) to which amino acids are absorbed into our bloodstream.
|
seven weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Chad Kerksick, PhD, Laboratory Director
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2019
Primary Completion (Actual)
December 3, 2019
Study Completion (Actual)
December 3, 2019
Study Registration Dates
First Submitted
June 1, 2020
First Submitted That Met QC Criteria
June 8, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 8, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-20-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
All approved unidentified study data inside the laboratory will be saved within a research repository bank for future research questions.
Otherwise, participant data will be destroyed after three years of study completion to maintain IRB compliance.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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