Absorption; ChemicalsBBANCT05328271
A Pilot Study to Determine the Bioavailability of Oral Beta-Aminoisobutyric Acid (BAIBA) Ingestion
A study testing Beta-Aminoisobutyric Acid in people with Absorption; Chemicals, run by Lindenwood University at 1 site in United States.
Trial summary
Think of this section as your research "elevator pitch." Please briefly describe the question(s) or issues you are addressing with your research (limited to 100 words). You will be able to provide information on specific outcomes, hypothesis, or related analysis in a following question. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Absorption; Chemicals
- What is being tested?
- Beta-Aminoisobutyric Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participants will be between the ages of 18-50 years
- All participants will be required to abstain from taking any amino acid (i.e., BCAAs, creatine, - beta-alanine, carnitine, etc.) for 14 days prior to beginning this study and for the entire duration -of the study
- Body mass index between 18.5 - 29.9 kg/m2
- Report accumulating at least 30 minutes of physical activity three days per week
- All participants will be determined to be healthy through completion of a detailed health history questionnaires
Who cannot join
- Are less than 18 or greater than 50 years of age. Participants younger than 18 are excluded due to necessity of parental consent. Participants greater than 50 years old are excluded due to the anticipated age-related changes that occur in digestive function, medication use, and other - associated confounding comorbidities.
- Have a body mass index < 18.5 and > 29.9 kg/m2. Any participant with a BMI > 29.9 kg/m2 must have a body fat percentage below 30% to be eligible.
- No individuals with a BMI above 32.0 kg/m2 will be eligible, irrespective of their body composition.
- Have a fasting capillary glucose (-30 minutes) level > 110 mg/dL on two separate occasions.
- Currently smoke or have quit smoking within the past six months
- Are currently following a ketogenic diet or a very low-carbohydrate diet for the past 30 days.
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- Any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity, immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease will be excluded.
- Report accumulating less than 30 minutes of physical activity per day for at least three days per week.
- Do not or are not willing to abstain from alcohol, nicotine and caffeine for 12 hours prior to each visit will be excluded
- Do not or are not willing to abstain from exercise for 24 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
Think of this section as your research "elevator pitch." Please briefly describe the question(s) or issues you are addressing with your research (limited to 100 words). You will be able to provide information on specific outcomes, hypothesis, or related analysis in a following question.
Beta-amino isobutyric acid (BAIBA) is a myokine produced in skeletal muscle and has been shown to impact how our body metabolizes fuel. We seek to determine the bioavailability of different doses of orally ingested beta-aminoisobutyric acid (BAIBA).
Read the detailed description
Once determined eligible and provided consent, participants will be assigned in a randomized, double-blind, placebo-controlled, crossover fashion. Eligible study participants will complete one of five testing conditions outlined below. For each testing condition, study participants will arrive in the lab after observing an overnight fast. Upon arrival, participants will donate the first of seven venous blood samples. Follow-up blood samples will be collected at 30, 60, 90, 120, 240, 300 minutes. The first and last collected samples will be collected into one 8mL SST and three 4mL EDTA tubes, while the second, third, and forth collected samples will be into two 4mL EDTA tubes, and have aliquots of 600 ul of plasma isolated and frozen at -80oC. Collected plasma will be analyzed for changes in beta-aminoisobutyric acid (BAIBA) and biomarkers commonly assessed by physicians to evaluate healthy. Participants will observe a minimum of 48 hours washout between conditions.
- Conditions
- Absorption; Chemicals
- Being tested
- Beta-Aminoisobutyric Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-Aminoisobutyric AcidDietary supplement
All supplements provided to all research participants containing BAIBA, L-Valine or placebo will be procured and prepared in a similar manner. Briefly, beta-amino isobutyric acid (BAIBA), L-Valine (an amino acid), and a resistant starch commonly consumed in various foods will be used as test agents for this study protcol. All supplements (both BAIBA and Valine) as well as placebo are produced and provided by NNB Nutrition. A certificate of analysis is provided in the attachments for the BAIBA. All supplements (BAIBA, L-Valine, and placebo) will be administered in gelatin capsules and consumed with a specified amount of cold tap water. The same number of capsules will be administered each time. All doses will be capsulated by manufacturer prior to use in the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Beta-Aminoisobutyric Acid |
| 1500 mg L-Valine | Active comparator | 1500 mg L-Valine Receives: Dietary Supplement: Beta-Aminoisobutyric Acid |
| 250 mg Beta-Aminoisobutryic Acid | Experimental | 250 mg Beta-Aminoisobutryic Acid Receives: Dietary Supplement: Beta-Aminoisobutyric Acid |
| 500 mg Beta-Aminoisobutryic Acid | Experimental | 500 mg Beta-Aminoisobutryic Acid Receives: Dietary Supplement: Beta-Aminoisobutyric Acid |
| 1500 mg Beta-Aminoisobutryic Acid | Experimental | 1500 mg Beta-Aminoisobutryic Acid Receives: Dietary Supplement: Beta-Aminoisobutyric Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of BAIBA.
Plasma concentrations of BAIBA.
Measured: 4 hours
Secondary outcomes (3)
Complete Blood Count
Plasma and serum indicators of health
Measured: 4 hours
Comprehensive Metabolic Panel
Plasma and serum indicators of health
Measured: 4 hours
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 posted14 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 Absorption; ChemicalsStudies 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, placebo-controlled, crossover design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Collaborators
- NNB Nutrition
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328271
- Sponsor's protocol ID
- IRB-21-34
- Acronym
- BBA
- Status last verified
- Apr 2022
- First submitted
- 29 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krieger JM, Hagele AM, Orr LS, Walden KE, Gross KN, Mumford PW, Kerksick CM. Dose-Response Absorption Kinetics of Oral L-Beta-Aminoisobutyric Acid (L-BAIBA) Supplementation in Healthy Men and Women. J Diet Suppl. 2023;20(6):832-849. doi: 10.1080/19390211.2022.2128141. Epub 2022 Oct 2.
PubMed 36184601
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Bioavailability of Oral Beta-Aminoisobutyric Acid (BAIBA) Ingestion
- ClinicalTrials.gov ID
- NCT05328271
- Acronym / sponsor ID
- BBA / IRB-21-34
- Conditions
- Absorption; Chemicals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Collaborators
- NNB Nutrition
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 14 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.
Think of this section as your research "elevator pitch." Please briefly describe the question(s) or issues you are addressing with your research (limited to 100 words). You will be able to provide information on specific outcomes, hypothesis, or related analysis in a following question.
Beta-amino isobutyric acid (BAIBA) is a myokine produced in skeletal muscle and has been shown to impact how our body metabolizes fuel. We seek to determine the bioavailability of different doses of orally ingested beta-aminoisobutyric acid (BAIBA).
Detailed description
Once determined eligible and provided consent, participants will be assigned in a randomized, double-blind, placebo-controlled, crossover fashion. Eligible study participants will complete one of five testing conditions outlined below. For each testing condition, study participants will arrive in the lab after observing an overnight fast. Upon arrival, participants will donate the first of seven venous blood samples. Follow-up blood samples will be collected at 30, 60, 90, 120, 240, 300 minutes. The first and last collected samples will be collected into one 8mL SST and three 4mL EDTA tubes, while the second, third, and forth collected samples will be into two 4mL EDTA tubes, and have aliquots of 600 ul of plasma isolated and frozen at -80oC. Collected plasma will be analyzed for changes in beta-aminoisobutyric acid (BAIBA) and biomarkers commonly assessed by physicians to evaluate healthy. Participants will observe a minimum of 48 hours washout between conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Randomized, double-blind, placebo-controlled, crossover design
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Beta-Aminoisobutyric AcidMaltodextrin |
| 1500 mg L-Valine | Active comparator | Dietary Supplement: Beta-Aminoisobutyric Acid1500 mg L-Valine |
| 250 mg Beta-Aminoisobutryic Acid | Experimental | Dietary Supplement: Beta-Aminoisobutyric Acid250 mg Beta-Aminoisobutryic Acid |
| 500 mg Beta-Aminoisobutryic Acid | Experimental | Dietary Supplement: Beta-Aminoisobutyric Acid500 mg Beta-Aminoisobutryic Acid |
| 1500 mg Beta-Aminoisobutryic Acid | Experimental | Dietary Supplement: Beta-Aminoisobutyric Acid1500 mg Beta-Aminoisobutryic Acid |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All participants will be between the ages of 18-50 years
- All participants will be required to abstain from taking any amino acid (i.e., BCAAs, creatine, - beta-alanine, carnitine, etc.) for 14 days prior to beginning this study and for the entire duration -of the study
- Body mass index between 18.5 - 29.9 kg/m2
- Report accumulating at least 30 minutes of physical activity three days per week
- All participants will be determined to be healthy through completion of a detailed health history questionnaires
Key exclusion criteria (10 listed)
- Are less than 18 or greater than 50 years of age. Participants younger than 18 are excluded due to necessity of parental consent. Participants greater than 50 years old are excluded due to the anticipated age-related changes that occur in digestive function, medication use, and other - associated confounding comorbidities.
- Have a body mass index < 18.5 and > 29.9 kg/m2. Any participant with a BMI > 29.9 kg/m2 must have a body fat percentage below 30% to be eligible.
- No individuals with a BMI above 32.0 kg/m2 will be eligible, irrespective of their body composition.
- Have a fasting capillary glucose (-30 minutes) level > 110 mg/dL on two separate occasions.
- Currently smoke or have quit smoking within the past six 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 |
|---|---|---|
| Beta-Aminoisobutyric AcidAll supplements provided to all research participants containing BAIBA, L-Valine or placebo will be procured and prepared in a similar manner. Briefly, beta-amino isobutyric acid (BAIBA), L-Valine (an amino acid), and a resistant starch commonly consumed in various foods will be used as test agents for this study protcol. All supplements (both BAIBA and Valine) as well as placebo are produced and provided by NNB Nutrition. A certificate of analysis is provided in the attachments for the BAIBA. All supplements (BAIBA, L-Valine, and placebo) will be administered in gelatin capsules and consumed with a specified amount of cold tap water. The same number of capsules will be administered each time. All doses will be capsulated by manufacturer prior to use in the study protocol. | Dietary supplement | 1500 mg Beta-Aminoisobutryic Acid, 1500 mg L-Valine, 250 mg Beta-Aminoisobutryic Acid, 500 mg Beta-Aminoisobutryic Acid, Placebo |
Primary outcome
Plasma concentrations of BAIBA.
Time frame: 4 hours
Plasma concentrations of BAIBA.
3 secondary outcomes
Complete Blood Count
Time frame: 4 hours
Comprehensive Metabolic Panel
Time frame: 4 hours
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 14 Apr 2022.
- Derived from this study: PubMed 36184601Krieger JM, Hagele AM, Orr LS, Walden KE, Gross KN, Mumford PW, Kerksick CM. Dose-Response Absorption Kinetics of Oral L-Beta-Aminoisobutyric Acid (L-BAIBA) Supplementation in Healthy Men and Women. J Diet Suppl. 2023;20(6):832-849. doi: 10.1080/19390211.2022.2128141. Epub 2022 Oct 2.
- 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. 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 Beta-Aminoisobutyric Acid in people with Absorption; Chemicals, 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 5 inclusion and 10 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 14 Apr 2022. 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 BAIBA. (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 NCT05328271, 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 14 Apr 2022.