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OpenTrials
Completed

NCT Number: NCT05328271

A Pilot Study to Determine the Bioavailability of Oral Beta-Aminoisobutyric Acid (BAIBA) Ingestion

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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).

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lindenwood University

Saint Charles, Missouri, 63301, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Beta-Aminoisobutyric Acid

Dietary 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.

Primary outcomes

  1. Plasma concentrations of BAIBA.

    Time frame: 4 hours

    Plasma concentrations of BAIBA.

Secondary outcomes

  1. Complete Blood Count

    Time frame: 4 hours

    Plasma and serum indicators of health

  2. Comprehensive Metabolic Panel

    Time frame: 4 hours

    Plasma and serum indicators of health

  3. Adverse Events

    Time frame: 4 hours

    Incidence and associations of reported adverse events

Sponsors and collaborators

Lead sponsor

Lindenwood University

Other

Collaborators

  • NNB Nutrition

Registry information

Acronym: BBA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2022
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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