Focus of Study is Amino Acid Appearace in BloodNCT04491188
Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic Supplementation
A study testing Bacillus subtilis DE111 in people with Focus of Study is Amino Acid Appearace in Blood, run by Lipscomb University at 1 site in United States.
Trial summary
Active males and females consumed a probiotic for 28-days. Before and after the intervention period, participants reported to the lab in a fasted state where they consumed 25 grams of whey protein. Following drink consumption, participants provided blood draws at 15-minute intervals. Read more about this study
- Who is it for?
- Ages 18 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of Study is Amino Acid Appearace in Blood
- What is being tested?
- Bacillus subtilis DE111
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 3 May 2018
- 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 34 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-34 years old Participants must have at least 1 year of resistance training experience.
- Free of any physical limitations, medications, and supplements that may affect performance, as determined by a health and activity questionnaire.
- Are free of musculoskeletal injuries
- Are not taking medications that may interfere with study measurements
Who cannot join
- Taking any other nutritional supplement or performance enhancing drug.
- Any chronic illness that causes continuous medical care
- Taking any other nutritional supplement or performance enhancing drug.
- Any chronic illness that causes continuous medical care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic (Bacillus Subtilis DE111) Supplementation in Active Men and Women
Active males and females consumed a probiotic for 28-days. Before and after the intervention period, participants reported to the lab in a fasted state where they consumed 25 grams of whey protein. Following drink consumption, participants provided blood draws at 15-minute intervals. Blood samples were analyzed for amino acid concentrations.
- Being tested
- Bacillus subtilis DE111, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus subtilis DE111Dietary supplement
1 x10-9 CFU Bacillus subtilis DE111 probiotic
PlaceboDietary supplement
Maltodextrin placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | 1 x10-9 CFU Bacillus subtilis DE111 was consumed daily for 28-days Receives: Dietary Supplement: Bacillus subtilis DE111 |
| Placebo | Placebo comparator | Maltodextrin placebo was consumed for 28-days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Amino Acid response
We measured plasma amino acid concentrations before and after the 28-day intervention
Measured: 28-days
Secondary outcomes (1)
Body Composition
Body Fat Percentage (%) will be monitored before and after the intervention via Bioelectical Impedance Analysis.
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start8 Jan 2018
- Primary completion3 May 2018
- Study completion3 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study is Amino Acid Appearace in BloodStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipscomb University
- Sponsor type
- University, hospital or other
- Collaborators
- Deerland Enzymes
- Responsible party
- Principal investigator, Jeremy Townsend, Lipscomb University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491188
- Sponsor's protocol ID
- 01082018
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic (Bacillus Subtilis DE111) Supplementation in Active Men and Women
- ClinicalTrials.gov ID
- NCT04491188
- Acronym / sponsor ID
- 01082018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Lipscomb UniversityUniversity, hospital or other
- Collaborators
- Deerland Enzymes
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 29 Jul 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.
Active males and females consumed a probiotic for 28-days. Before and after the intervention period, participants reported to the lab in a fasted state where they consumed 25 grams of whey protein. Following drink consumption, participants provided blood draws at 15-minute intervals. Blood samples were analyzed for amino acid concentrations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Bacillus subtilis DE1111 x10-9 CFU Bacillus subtilis DE111 was consumed daily for 28-days |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin placebo was consumed for 28-days |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-34 years old Participants must have at least 1 year of resistance training experience.
- Free of any physical limitations, medications, and supplements that may affect performance, as determined by a health and activity questionnaire.
- Are free of musculoskeletal injuries
- Are not taking medications that may interfere with study measurements
Key exclusion criteria (4 listed)
- Taking any other nutritional supplement or performance enhancing drug.
- Any chronic illness that causes continuous medical care
- Taking any other nutritional supplement or performance enhancing drug.
- Any chronic illness that causes continuous medical care.
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 |
|---|---|---|
| Bacillus subtilis DE1111 x10-9 CFU Bacillus subtilis DE111 probiotic | Dietary supplement | Probiotic |
| PlaceboMaltodextrin placebo | Dietary supplement | Placebo |
Primary outcome
Plasma Amino Acid response
Time frame: 28-days
We measured plasma amino acid concentrations before and after the 28-day intervention
1 secondary outcome
Body Composition
Time frame: 28-days
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 29 Jul 2020.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacillus subtilis DE111 in people with Focus of Study is Amino Acid Appearace in Blood, run by Lipscomb 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 4 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: finished, as of the sponsor's last update on 29 Jul 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. 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?
Plasma Amino Acid response (time frame: 28-days). 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 29 Jul 2020.