Clinical trial NCT05328271: A Pilot Study to Determine the Bioavailability of Oral Beta-Aminoisobutyric Acid (BAIBA) Ingestion
Official title: A Pilot Study to Determine the Bioavailability of Oral Beta-Aminoisobutyric Acid (BAIBA) Ingestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Absorption; Chemicals
Lead sponsor: Lindenwood University
Sponsor class: OTHER
Collaborators: name: NNB Nutrition
First posted: 2022-04-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, placebo-controlled, crossover design
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Plasma concentrations of BAIBA.
timeFrame: 4 hours
Secondary outcomes:
measure: Complete Blood Count
timeFrame: 4 hours
measure: Comprehensive Metabolic Panel
timeFrame: 4 hours
measure: Adverse Events
timeFrame: 4 hours
Other outcomes:
Locations:
city: Saint Charles
country: United States
facility: Lindenwood University
state: Missouri
Study officials:
References:
citation: 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.