Protein MalabsorptionABCNCT05313178
Changes in Plasma Amino Acid Appearance After Adding Bacillus Coagulans GBI-30, 6086 to Milk Protein Concentrate
A study testing Bacillus Coagulans GBI-30, 6086 in people with Protein Malabsorption, run by Lindenwood University at 1 site in United States.
Trial summary
The purpose of this study is to examine the pattern of plasma amino acid appearance after a two-week daily regimen of milk protein concentrate supplementation with and without the addition of Bacillus coagulans GBI-30, 6086 among older women. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Protein Malabsorption
- What is being tested?
- Bacillus Coagulans GBI-30, 6086
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 1 Feb 2022
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants will be between the ages of 50-70 years
- Completing at least 30 minutes of physical activity at minimum three days per week
Who cannot join
- As indicated on a medical history form they complete, any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index > 30 kg/m2), immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease
- Any woman who is taking a medication known to impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients
- Any woman currently taking a probiotic or a dietary supplement that may impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients
- 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 overnight (8-10 hours)
- Participants who do not or are not willing to abstain from exercise for 24 hours prior to each visit
- Women who are pregnant
- Women who are lactose intolerant
Trial locations and contacts
1 site in 1 country.
United States1 site
Lindenwood University
Saint Charles, Missouri, 63301
About this study
Official title: Acute Changes in Plasma Amino Acid Appearance After Adding Bacillus Coagulans GBI-30, 6086 to Milk Protein Concentrate in Older Women
The purpose of this study is to examine the pattern of plasma amino acid appearance after a two-week daily regimen of milk protein concentrate supplementation with and without the addition of Bacillus coagulans GBI-30, 6086 among older women.
Read the detailed description
Once determined eligible and providing consent, 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. Upon ingestion of their final assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect approximately 10mL of venous blood from a forearm vein at specific time intervals up to four hours after ingestion of their final assigned supplementation dose for that period in the study protocol.
- Conditions
- Protein Malabsorption
- Being tested
- Bacillus Coagulans GBI-30, 6086
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus Coagulans GBI-30, 6086Dietary supplement
In a randomized, double-blind, crossover fashion, study participants will supplement on a daily basis for two weeks during one study period with a 25-gram dose of either milk protein concentrate or a 25-gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086. Each dose will be ingested at the same time of day with 8 - 12 fluid ounces of cold tap water. All participants will be required to complete a supplementation log to document when each dose of their assigned protein is consumed. Upon completion of their first assigned study protocol period, participants will observe a three-week washout period by returning to their normal dietary intake and physical activity habits before beginning supplementation for the remaining study period.
| Study group | Role | What they receive |
|---|---|---|
| Milk Protein | Placebo comparator | 25-gram dose of milk protein concentrate Receives: Dietary Supplement: Bacillus Coagulans GBI-30, 6086 |
| Milk Protein and Probiotic | Experimental | 25-gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086 Receives: Dietary Supplement: Bacillus Coagulans GBI-30, 6086 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentrations of Amino Acids in Blood
Plasma Concentrations of Amino Acids in Blood
Measured: 4 hours
Secondary outcomes (1)
Adverse Events
Incidence and associations of reported adverse events
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start20 Nov 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
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 Protein MalabsorptionStudies 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
- Model description
- Randomized, double-blind, crossover study design
- 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
- Collaborators
- Increnovo LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313178
- Sponsor's protocol ID
- IRB-21-57
- Acronym
- ABC
- Status last verified
- Oct 2024
- First submitted
- 29 Mar 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walden KE, Hagele AM, Orr LS, Gross KN, Krieger JM, Jager R, Kerksick CM. Probiotic BC30 Improves Amino Acid Absorption from Plant Protein Concentrate in Older Women. Probiotics Antimicrob Proteins. 2024 Feb;16(1):125-137. doi: 10.1007/s12602-022-10028-4. Epub 2022 Dec 14.
PubMed 36515888
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Changes in Plasma Amino Acid Appearance After Adding Bacillus Coagulans GBI-30, 6086 to Milk Protein Concentrate in Older Women
- ClinicalTrials.gov ID
- NCT05313178
- Acronym / sponsor ID
- ABC / IRB-21-57
- Conditions
- Protein Malabsorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Collaborators
- Increnovo LLC
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 6 Apr 2022 (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 pattern of plasma amino acid appearance after a two-week daily regimen of milk protein concentrate supplementation with and without the addition of Bacillus coagulans GBI-30, 6086 among older women.
Detailed description
Once determined eligible and providing consent, 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. Upon ingestion of their final assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect approximately 10mL of venous blood from a forearm vein at specific time intervals up to four hours after ingestion of their final assigned supplementation dose for that period in the study protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, crossover study design
| Arm | Type | Receives |
|---|---|---|
| Milk Protein | Placebo comparator | Dietary Supplement: Bacillus Coagulans GBI-30, 608625-gram dose of milk protein concentrate |
| Milk Protein and Probiotic | Experimental | Dietary Supplement: Bacillus Coagulans GBI-30, 608625-gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086 |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All participants will be between the ages of 50-70 years
- Completing at least 30 minutes of physical activity at minimum three days per week
Key exclusion criteria (8 listed)
- As indicated on a medical history form they complete, any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index > 30 kg/m2), immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease
- Any woman who is taking a medication known to impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients
- Any woman currently taking a probiotic or a dietary supplement that may impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients
- 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 overnight (8-10 hours)
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 Coagulans GBI-30, 6086In a randomized, double-blind, crossover fashion, study participants will supplement on a daily basis for two weeks during one study period with a 25-gram dose of either milk protein concentrate or a 25-gram dose of milk protein concentrate with bacillus coagulans GBI-30, 6086. Each dose will be ingested at the same time of day with 8 - 12 fluid ounces of cold tap water. All participants will be required to complete a supplementation log to document when each dose of their assigned protein is consumed. Upon completion of their first assigned study protocol period, participants will observe a three-week washout period by returning to their normal dietary intake and physical activity habits before beginning supplementation for the remaining study period. | Dietary supplement | Milk Protein, Milk Protein and Probiotic |
Primary outcome
Plasma Concentrations of Amino Acids in Blood
Time frame: 4 hours
Plasma Concentrations of Amino Acids in Blood
1 secondary outcome
Adverse Events
Time frame: 4 hours
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 17 Oct 2024.
- Derived from this study: PubMed 36515888Walden KE, Hagele AM, Orr LS, Gross KN, Krieger JM, Jager R, Kerksick CM. Probiotic BC30 Improves Amino Acid Absorption from Plant Protein Concentrate in Older Women. Probiotics Antimicrob Proteins. 2024 Feb;16(1):125-137. doi: 10.1007/s12602-022-10028-4. Epub 2022 Dec 14.
- Individual participant dataSharing planned: No
Related trials for Protein Malabsorption
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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.
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 Coagulans GBI-30, 6086 in people with Protein Malabsorption, 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 2 inclusion and 8 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 17 Oct 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?
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 Concentrations of Amino Acids in Blood (time frame: 4 hours). 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 NCT05313178, 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 17 Oct 2024; AzTrials last refreshed its copy on 29 Oct 2026.