An interventional study of Beta-Aminoisobutyric Acid in Absorption; Chemicals, sponsored by Lindenwood University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by Lindenwood University · Not applicable, Interventional, and Other
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).
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.
Lindenwood University is the lead sponsor of 29 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Maltodextrin
Dietary Supplement: Beta-Aminoisobutyric Acid
1500 mg L-Valine
Dietary Supplement: Beta-Aminoisobutyric Acid
250 mg Beta-Aminoisobutryic Acid
Dietary Supplement: Beta-Aminoisobutyric Acid
500 mg Beta-Aminoisobutryic Acid
Dietary Supplement: Beta-Aminoisobutyric 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.
Plasma concentrations of BAIBA.
Plasma concentrations of BAIBA.
Time frame: 4 hours
Complete Blood Count
Plasma and serum indicators of health
Time frame: 4 hours
Comprehensive Metabolic Panel
Plasma and serum indicators of health
Time frame: 4 hours
Adverse Events
Incidence and associations of reported adverse events
Time frame: 4 hours
Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Lindenwood University