BBA: A Pilot Study to Determine the Bioavailability of Oral Beta-Aminoisobutyric Acid (BAIBA) Ingestion
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Maltodextrin |
Dietary Supplement: Beta-Aminoisobutyric Acid
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.
|
| Active Comparator: 1500 mg L-Valine 1500 mg L-Valine |
Dietary Supplement: Beta-Aminoisobutyric Acid
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.
|
| Experimental: 250 mg Beta-Aminoisobutryic Acid 250 mg Beta-Aminoisobutryic Acid |
Dietary Supplement: Beta-Aminoisobutyric Acid
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.
|
| Experimental: 500 mg Beta-Aminoisobutryic Acid 500 mg Beta-Aminoisobutryic Acid |
Dietary Supplement: Beta-Aminoisobutyric Acid
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.
|
| Experimental: 1500 mg Beta-Aminoisobutryic Acid 1500 mg Beta-Aminoisobutryic Acid |
Dietary Supplement: Beta-Aminoisobutyric Acid
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.
|
Outcome Measures
Primary Outcome Measures
- Plasma concentrations of BAIBA. [4 hours]
Plasma concentrations of BAIBA.
Secondary Outcome Measures
- Complete Blood Count [4 hours]
Plasma and serum indicators of health
- Comprehensive Metabolic Panel [4 hours]
Plasma and serum indicators of health
- Adverse Events [4 hours]
Incidence and associations of reported adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
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All participants will be between the ages of 18-50 years
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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
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Body mass index between 18.5 - 29.9 kg/m2
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Report accumulating at least 30 minutes of physical activity three days per week
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All participants will be determined to be healthy through completion of a detailed health history questionnaires
Exclusion Criteria:
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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.
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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.
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No individuals with a BMI above 32.0 kg/m2 will be eligible, irrespective of their body composition.
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Have a fasting capillary glucose (-30 minutes) level > 110 mg/dL on two separate occasions.
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Currently smoke or have quit smoking within the past six months
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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.
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Report accumulating less than 30 minutes of physical activity per day for at least three days per week.
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Do not or are not willing to abstain from alcohol, nicotine and caffeine for 12 hours prior to each visit will be excluded
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Do not or are not willing to abstain from exercise for 24 hours prior to each visit will be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lindenwood University | Saint Charles | Missouri | United States | 63301 |
Sponsors and Collaborators
- Lindenwood University
- NNB Nutrition
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-21-34