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An open-label, acute clinical trial in adults to assess ketone levels, gastrointestinal tolerability, and sleepiness following consumption of (R)-1,3-butanediol (Avela™)

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논문

An open-label, acute clinical trial in adults to assess ketone levels, gastrointestinal tolerability, and sleepiness following consumption of (R)-1,3-butanediol (Avela™)

학술지

Frontiers in physiology

저자명

Lowder, James; Fallah, Shafagh; Venditti, Carolina; Musa-Veloso, Kathy; Kotlov, Vassili

초록

<P><B>Introduction:</B> A study was undertaken to determine the acute effects of a beverage made with Avela&trade; (<I>R</I>)-1,3-butanediol, on blood beta-hydroxybutyrate (BHB) levels (using the Keto-Mojo monitor), gastrointestinal (GI) tolerability (using the modified visual analogue scale GI Symptoms Tool), and sleepiness (using the Stanford Sleepiness Scale).</P><P><B>Methods:</B> Following a 12-h overnight fast, 26 healthy adults consumed one beverage containing 11.5&nbsp;g of (<I>R</I>)-1,3-butanediol at each of 0, 30, and 60&nbsp;min, culminating in a total intake of 34.5&nbsp;g of (<I>R</I>)-1,3-butanediol. Blood BHB levels, GI tolerability, and sleepiness were assessed at baseline (0&nbsp;min), and at 30, 60, 90, 120, 180, 240, and 300&nbsp;min. At 240&nbsp;min, a protein bar was consumed.</P><P><B>Results:</B> The mean (±SD) BHB fasting baseline level, maximal concentration, time at maximal concentration, and incremental area under the curve over 300&nbsp;min were 0.23 ± 0.21&nbsp;mmol/L, 2.10 ± 0.97&nbsp;mmol/L, 133.85 ± 57.07&nbsp;min, and 376.73 ± 156.76&nbsp;mmol/L*min, respectively. BHB levels at each time point were significantly increased relative to baseline. In females, BHB T<SUB>max</SUB> was significantly greater (<I>p</I> = 0.046), and BHB iAUC<SUB>0&#x2013;300&nbsp;min</SUB> nearly significantly greater (<I>p</I> = 0.06) than in males.</P><P><B>Discussion:</B> The beverage formulated with Avela&trade; had no impact on sleepiness and was generally well-tolerated, with no or mild GI symptoms reported in most participants. Mild headaches were reported as an adverse event by five participants and judged possibly related to the study product in two of the participants.</P>

발행연도

2023

발행기관

Frontiers Media S.A.

ISSN

1664-042x

14

페이지

pp.1195702

주제어

butanediol; beta-hydroxybutyrate; ketosis; ketones; BHB

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1 2023-12-11

논문; 2023-01-01

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