Amino Acid AbsorptionNCT04427020
Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding
A study testing Milk protein + GBI-30 and Milk protein in people with Amino Acid Absorption, run by Lindenwood University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Amino Acid Absorption
- What is being tested?
- Milk protein + GBI-30 and Milk protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2019to 3 Dec 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lindenwood University
Saint Charles, Missouri, 63301
About this study
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.
Read the 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.
- Conditions
- Amino Acid Absorption
- Being tested
- Milk protein + GBI-30, Milk protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk protein + GBI-30Dietary supplement
Both conditions matched flavor, color, and serving size
Milk proteinDietary supplement
Both conditions matched flavor, color, and serving size
| Study group | Role | What they receive |
|---|---|---|
| Milk Protein + Probiotic | Experimental | 25 gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086 Receives: Dietary Supplement: Milk protein + GBI-30 |
| Milk Protein | Active comparator | 25 gram dose of milk protein concentrate Receives: Dietary Supplement: Milk protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of amino acid absorption
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.
Measured: seven weeks
Concentration of amino acid absorption
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.
Measured: seven weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start8 Aug 2019
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amino Acid AbsorptionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad Kerksick, PhD, Study director, Laboratory Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427020
- Sponsor's protocol ID
- IRB-20-15
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Stecker RA, Moon JM, Russo TJ, Ratliff KM, Mumford PW, Jager R, Purpura M, Kerksick CM. Bacillus coagulans GBI-30, 6086 improves amino acid absorption from milk protein. Nutr Metab (Lond). 2020 Oct 23;17:93. doi: 10.1186/s12986-020-00515-2. eCollection 2020.
PubMed 33110439
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding
- ClinicalTrials.gov ID
- NCT04427020
- Acronym / sponsor ID
- IRB-20-15
- Conditions
- Amino Acid Absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 11 Jun 2020 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk Protein + Probiotic | Experimental | Dietary Supplement: Milk protein + GBI-3025 gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086 |
| Milk Protein | Active comparator | Dietary Supplement: Milk protein25 gram dose of milk protein concentrate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Milk protein + GBI-30Both conditions matched flavor, color, and serving size | Dietary supplement | Milk Protein + Probiotic |
| Milk proteinBoth conditions matched flavor, color, and serving size | Dietary supplement | Milk Protein |
Primary outcome
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.
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.
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 11 Jun 2020.
- Derived from this study: PubMed 33110439Stecker RA, Moon JM, Russo TJ, Ratliff KM, Mumford PW, Jager R, Purpura M, Kerksick CM. Bacillus coagulans GBI-30, 6086 improves amino acid absorption from milk protein. Nutr Metab (Lond). 2020 Oct 23;17:93. doi: 10.1186/s12986-020-00515-2. eCollection 2020.
- Individual participant dataSharing planned: No. 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.
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Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding
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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.
Chad Kerksick, PhD study director
Laboratory Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk protein + GBI-30 and Milk protein in people with Amino Acid Absorption, run by Lindenwood University 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 11 Jun 2020. 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. 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?
Rate of amino acid absorption (time frame: seven weeks). The study lists 2 primary outcomes in all. 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 NCT04427020, which also lists 1 linked publication.
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 11 Jun 2020.