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

NCT05328271 | Completed

• 1 other identifier: IRB-21-34
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Absorption; Chemicals

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of BAIBA.

  Plasma concentrations of BAIBA.

  4 hours

Secondary Outcomes (3)

• Complete Blood Count

  4 hours

• Comprehensive Metabolic Panel

  4 hours

• Adverse Events

  4 hours

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Beta-Aminoisobutyric Acid

1500 mg L-Valine

ACTIVE COMPARATOR

1500 mg L-Valine

Dietary Supplement: Beta-Aminoisobutyric Acid

250 mg Beta-Aminoisobutryic Acid

EXPERIMENTAL

250 mg Beta-Aminoisobutryic Acid

Dietary Supplement: Beta-Aminoisobutyric Acid

500 mg Beta-Aminoisobutryic Acid

EXPERIMENTAL

500 mg Beta-Aminoisobutryic Acid

Dietary Supplement: Beta-Aminoisobutyric Acid

1500 mg Beta-Aminoisobutryic Acid

EXPERIMENTAL

1500 mg Beta-Aminoisobutryic Acid

Dietary Supplement: Beta-Aminoisobutyric Acid

Interventions

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.

1500 mg Beta-Aminoisobutryic Acid; 1500 mg L-Valine; 250 mg Beta-Aminoisobutryic Acid; 500 mg Beta-Aminoisobutryic Acid; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lindenwood University: lead
• NNB Nutrition: collaborator

Study Sites (1)

Lindenwood University

Saint Charles, Missouri, 63301, United States

Location

Related Publications (1)

• 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.

  PMID: 36184601 DERIVED

MeSH Terms

Interventions

3-aminoisobutyric acid

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Supplements blinded to participant and investigator by third party
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, crossover design

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 14, 2022
• Study Start: November 20, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)