A randomized, open-label, parallel pilot study investigating metabolic product kinetics of the novel ketone ester, bis-hexanoyl (R)-1,3-butanediol, over one week of ingestion in healthy adults.

Introduction: Bis-hexanoyl (R)-1,3-butanediol (BH-BD) is a novel ketone ester that, when consumed, is hydrolyzed into hexanoic acid (HEX) and (R)-1,3-butanediol (BDO) which are subsequently metabolized into beta-hydroxybutyrate (BHB). Methods: We undertook a randomized, parallel, open-label study in healthy adults (n = 33) to elucidate blood BHB, HEX and BDO concentrations for 8 h following consumption of three different serving sizes (SS) of BH-BD (12.5, 25 and 50 g/day) before (Day 0) and after 7 days of daily BH-BD consumption (Day 7). Results: Maximal concentration and area under the curve of all metabolites increased proportionally to SS and were greatest for BHB followed by BDO then HEX on both Day 0 and 7. Metabolite half-life tended to decrease with increasing SS for BHB and HEX. Time to peak concentration increased with increasing SS for BHB and BDO on both days. In vitro incubation of BH-BD in human plasma demonstrated BH-BD undergoes rapid spontaneous hydrolysis. Conclusion: These results demonstrate that orally ingested BH-BD is hydrolyzed into products that appear in the plasma and undergo conversion to BHB in a SS dependent manner, and that metabolism of BH-BD neither becomes saturated at serving sizes up to 50 g nor displays consistent adaptation after 7 days of daily consumption.

Tolerability and Safety of a Novel Ketogenic Ester, Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults.

Nutritional ketosis is a state of mildly elevated blood ketone concentrations resulting from dietary changes (e.g., fasting or reduced carbohydrate intake) or exogenous ketone consumption. In this study, we determined the tolerability and safety of a novel exogenous ketone diester, bis-hexanoyl-(R)-1,3-butanediol (BH-BD), in a 28-day, randomized, double-blind, placebo-controlled, parallel trial (NCT04707989). Healthy adults (n = 59, mean (SD), age: 42.8 (13.4) y, body mass index: 27.8 (3.9) kg/m2) were randomized to consume a beverage containing 12.5 g (Days 0-7) and 25 g (Days 7-28) of BH-BD or a taste-matched placebo daily with breakfast. Tolerability, stimulation, and sedation were assessed daily by standardized questionnaires, and blood and urine samples were collected at Days 0, 7, 14, and 28 for safety assessment. There were no differences in at-home composite systemic and gastrointestinal tolerability scores between BH-BD and placebo at any time in the study, or in acute tolerability measured 1-h post-consumption in-clinic. Weekly at-home composite tolerability scores did not change when BH-BD servings were doubled. At-home scores for stimulation and sedation did not differ between groups. BH-BD significantly increased blood ketone concentrations 1-h post-consumption. No clinically meaningful changes in safety measures including vital signs and clinical laboratory measurements were detected within or between groups. These results support the overall tolerability and safety of consumption of up to 25 g/day BH-BD.

Trajectory of Weight Patterns in Urban Youth Throughout Their Stay in a Juvenile Justice System.

Incarceration is associated with health risks including overweight and obesity. This study explored obesity rates and weight gain in incarcerated youth by tracking weight trajectory during continuous stays in juvenile justice facilities. Among 65 youth, mean weight gain was 17.8 pounds and significant, F(2, 12) = 25.44, p = .03. Youth gained an average of 15.6 pounds (standard deviation [ SD] = 3.6) during the initial incarceration period (mean = 71 days). From the assessment to treatment period (mean = 46 days), mean weight gain was 4.1 pounds ( SD = 4.3), which also was significant, F(2, 12) = 28.57, p = .03. Body mass index z-scores increased significantly for each monthly weight observation. Being incarcerated is associated with significant weight gain and should influence policy and planning in this setting.

Weight patterns of youth entering an urban juvenile justice facility.

Adolescents with a history of incarceration face a disproportionate number of health issues compared with their peers in virtually all areas, including perceived well-being; self-esteem; acute, chronic, and psychosocial disorders; and physical activity. Some studies have shown correlates of weight status and incarceration; however, the literature is conflicting. The current study sought to assess weight patterns of primarily minority urban youth (N = 548) entering a juvenile justice facility as well as associations between medications and weight status. Results indicate incarcerated adolescents have higher rates of overweight and obesity (40%) in comparison with nonincarcerated adolescents in the state (20 to 30%) or surrounding community (30 to 34%). Of interest, incarcerated adolescents taking asthma medications have significantly higher rates of overweight and obesity when compared with those not taking asthma medications. The clinical implications of these findings are discussed and implications for future research explored.

Low incidence of complications in asthmatic patients treated with preoperative corticosteroids.

The purpose of this study is to establish the incidence of perioperative complications in asthmatic patients treated with preoperative corticosteroids and to compare these rates to the general surgical population at the same hospital. Using a retrospective cohort design, we studied 172 patients who underwent 249 procedures at our hospital between 1986 and 2002. Preoperative corticosteroids were administered in 240 of the procedures. The rate of asthma exacerbations, infections, wound infections, delayed wound healing, adrenocortical insufficiency, and mortality was assessed. Thirteen patients (5.2%) developed postoperative bronchospasm. Nine (3.6%) developed postoperative infections, four of which were wound infections (1.6%). There were no patients with adrenal insufficiency. One death occurred intraoperatively as a result of a neurosurgical complication. There was no statistical difference in the incidence of infections between our asthma population and the general surgical population in the same hospital except in gynecologic procedures. We conclude that asthmatic patients who are treated with corticosteroids before undergoing surgery have a low incidence of complications.