Amino Acid AbsorptionNCT06701604
Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding
A study testing Single Strain Probiotic + Milk Protein in people with Amino Acid Absorption and Probiotic, run by The Archer-Daniels-Midland Company at 1 site in United States.
Trial summary
The purpose of this study is to examine the rate and concentration of amino acid absorption after a three-week pattern of milk protein supplementation with and without the addition of a single strain probiotic. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Amino Acid Absorption, Probiotic
- What is being tested?
- Single Strain Probiotic + Milk Protein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be male or female between the ages of 18-35 years;
- Participants have not been consuming any nutritional supplements for the preceding 6-week period;
- Participants have not been consuming any ergogenic aids for the preceding 6-week period;
- Participant has provided written and dated informed consent to participate in the study;
- Participant is willing and able to comply with the protocol;
- Participant is apparently healthy and free from disease, as determined by a health history questionnaire;
Who cannot join
- Participant is allergic to any ingredient in the nutritional supplement or placebo;
- Participant is not pregnant or trying to become pregnant, nor breast feeding;
- Participant reports any unusual adverse events associated with this study that in consultation with the study investigators or their doctor recommends removal from the study;
- Participant currently ingests nicotine or has quit within the last 6 months;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Mary Hardin-Baylor
Belton, Texas, 76513
Lem Taylor, PhD, 254-295-4895, ltaylor@umhb.edu
About this study
Official title: Comparative Differences of Amino Acid Appearance with Milk Protein Ingestion with and Without Probiotic Supplementation
The purpose of this study is to examine the rate and concentration of amino acid absorption after a three-week pattern of milk protein supplementation with and without the addition of a single strain probiotic.
Read the detailed description
The study will be conducted using a randomized, double-blind, crossover study design. Thirty healthy men and women between 18 - 35 years of age will be recruited to participate in this study. Two supplementation protocols that each span three weeks will be completed and separated with a washout period of three weeks. Participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a powder milk protein and placebo or a single daily 25-gram dose of a powder milk protein plus a single strain probiotic. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured. On the day of experimental testing, subjects will arrive to the laboratory in a fasted state. Subjects will rest semi-supine for multiple blood sampling. Following baseline sampling, participants will ingest their respective supplement plus a standard bolus of milk protein (powder form, mixed with 12 fl oz of cold water). Thereafter, blood samples will be taken at 30, 60, 90, 120, 180, and 240 minutes post-ingestion. Study participants will be provided an additional three-week supply of the alternative treatment to begin after observing a three-week washout. After three weeks of supplementation, study participants will return to the laboratory for their remaining testing visit.
- Conditions
- Amino Acid Absorption, Probiotic
- Being tested
- Single Strain Probiotic + Milk Protein, Placebo + Milk Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Strain Probiotic + Milk ProteinDietary supplement
- Both conditions matched flavor, color, and serving size
Placebo + Milk ProteinDietary supplement
- Both conditions matched flavor, color, and serving size
| Study group | Role | What they receive |
|---|---|---|
| Milk Protein + Probiotic | Experimental | Arm receiving investigational product (probiotic) in the form of a capsule with a dose of 1B Colony Forming Unit (CFU) per day + a 25-gram dose of milk protein concentrate given daily for 3 weeks Receives: Dietary Supplement: Single Strain Probiotic + Milk Protein |
| Milk Protein + Placebo | Placebo comparator | Arm receiving placebo matching investigational product + a 25-gram dose of milk protein concentrate given daily for 3 weeks Receives: Dietary Supplement: Placebo + Milk Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of amino acid absorption
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: Day 0, Day 22, Day 65
Concentration of amino acid absorption
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: Day 0, Day 22, Day 65
Secondary outcomes (2)
Comprehensive metabolic panel
Comprehensive metabolic panel will be assessed pre vs. post supplementation across the two treatment groups for blood safety data.
- All measures are assessed by blood or serum assay analysis
Measured: Day 0, Day 22, Day 65
Blood CBC panel
Blood CBC panel will be assessed pre vs. post supplementation across the two treatment groups for blood safety data.
- All measures are assessed by blood or serum assay analysis
Measured: Day 0, Day 22, Day 65
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start2 Dec 2024 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Mary Hardin-Baylor
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701604
- Sponsor's protocol ID
- PCTB202104D
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Differences of Amino Acid Appearance with Milk Protein Ingestion with and Without Probiotic Supplementation
- ClinicalTrials.gov ID
- NCT06701604
- Acronym / sponsor ID
- PCTB202104D
- Conditions
- Amino Acid Absorption, Probiotic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- University of Mary Hardin-Baylor
- Study start
- 2 Dec 2024 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 22 Nov 2024 (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 rate and concentration of amino acid absorption after a three-week pattern of milk protein supplementation with and without the addition of a single strain probiotic.
Detailed description
The study will be conducted using a randomized, double-blind, crossover study design. Thirty healthy men and women between 18 - 35 years of age will be recruited to participate in this study. Two supplementation protocols that each span three weeks will be completed and separated with a washout period of three weeks. Participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a powder milk protein and placebo or a single daily 25-gram dose of a powder milk protein plus a single strain probiotic. Upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured. On the day of experimental testing, subjects will arrive to the laboratory in a fasted state. Subjects will rest semi-supine for multiple blood sampling. Following baseline sampling, participants will ingest their respective supplement plus a standard bolus of milk protein (powder form, mixed with 12 fl oz of cold water). Thereafter, blood samples will be taken at 30, 60, 90, 120, 180, and 240 minutes post-ingestion. Study participants will be provided an additional three-week supply of the alternative treatment to begin after observing a three-week washout. After three weeks of supplementation, study participants will return to the laboratory for their remaining testing visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk Protein + Probiotic | Experimental | Dietary Supplement: Single Strain Probiotic + Milk ProteinArm receiving investigational product (probiotic) in the form of a capsule with a dose of 1B Colony Forming Unit (CFU) per day + a 25-gram dose of milk protein concentrate given daily for 3 weeks |
| Milk Protein + Placebo | Placebo comparator | Dietary Supplement: Placebo + Milk ProteinArm receiving placebo matching investigational product + a 25-gram dose of milk protein concentrate given daily for 3 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants will be male or female between the ages of 18-35 years;
- Participants have not been consuming any nutritional supplements for the preceding 6-week period;
- Participants have not been consuming any ergogenic aids for the preceding 6-week period;
- Participant has provided written and dated informed consent to participate in the study;
- Participant is willing and able to comply with the protocol;
Key exclusion criteria (4 listed)
- Participant is allergic to any ingredient in the nutritional supplement or placebo;
- Participant is not pregnant or trying to become pregnant, nor breast feeding;
- Participant reports any unusual adverse events associated with this study that in consultation with the study investigators or their doctor recommends removal from the study;
- Participant currently ingests nicotine or has quit within the last 6 months;
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 |
|---|---|---|
| Single Strain Probiotic + Milk Protein• Both conditions matched flavor, color, and serving size | Dietary supplement | Milk Protein + Probiotic |
| Placebo + Milk Protein• Both conditions matched flavor, color, and serving size | Dietary supplement | Milk Protein + Placebo |
Primary outcome
Rate of amino acid absorption
Time frame: Day 0, Day 22, Day 65
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: Day 0, Day 22, Day 65
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.
2 secondary outcomes
Comprehensive metabolic panel
Time frame: Day 0, Day 22, Day 65
Blood CBC panel
Time frame: Day 0, Day 22, Day 65
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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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.
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 Strain Probiotic + Milk Protein in people with Amino Acid Absorption and Probiotic, run by The Archer-Daniels-Midland Company 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 22 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lem Taylor, PhD (254-295-4895, ltaylor@umhb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of amino acid absorption (time frame: Day 0, Day 22, Day 65). 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?
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 22 Nov 2024.