PD26-10 TREATMENT OF HYPOGONADAL MEN WITH ORAL TESTOSTERONE UNDECANOATE (TU) IMPROVES PSYCHO-SEXUAL, WELL-BEING AND BODY COMPOSITION PARAMETERS

2020 ◽  
Vol 203 ◽  
pp. e547
Author(s):  
Stanton Honig* ◽  
Kaminetsky Jed ◽  
Marc Gittelman ◽  
Ronald Swerdloff ◽  
Theodore Danoff ◽  
...  
2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Ronald S Swerdloff ◽  
John K Amory ◽  
Adrian S Dobs ◽  
Christina Wang ◽  
Theodore M Danoff ◽  
...  

Abstract Introduction and Objective: A new, first-in-class oral testosterone (T) replacement therapy product [T-undecanoate (TU) capsules] was recently approved by FDA to treat hypogonadal men. Clinical trials were conducted to evaluate, in part, the impact of oral TU therapy on important secondary efficacy endpoints: Psychosexual and/or general well-being (Trial I and II); and body composition and bone mineral density (BMD) (Trial II). Subject and Methods: Hypogonadal men (AM serum T ≤ 300 ng/dL) age 18 to 65 (Trial I) or 75 years old (Trial II) were randomized into open-label, active-comparator (T-gel/solution) trials. Subjects received: Trial 1: Oral TU (n=166) or a topical T solution (n=55) for 4-6 mos.; or Trial II: Oral TU (n=162) or T-gel (n=163) for 12 mos. The starting oral TU dose (with food) was 237 mg, BID in Trial I and 316 mg, BID in Trial II; up to 2 dose-titration opportunities were available to achieve eugonadal T concentrations (assayed by LC-MS/MS). In Trial I, Psychosexual Daily Questionnaires (PDQ) were completed by study subjects for 7 days at baseline and prior to final clinic visit (Day 105-180). In Trial II, the SF-36 well-being questionnaire was completed on Days 0, 30, 90, 180, 270 and 365 and PDQs were completed for 7 days prior to clinic visits on these same days. In Trial II body composition and BMD was assessed by DEXA scan on Days 0, 180 and 365. Safety was monitored by physical exam and standard clinical lab tests. Results: Mean serum T in response to oral TU was 489 ± 155 ng/dL (mean ± SD) (Trial I) and 628 ± 342 ng/dL (Trial II); 84% of subjects in each trial achieved mean T concentrations in the eugonadal range. Statistically significant mean changes from baseline (p<0.0001) for most SF-36 well-being parameters were observed in both oral TU and T-gel groups. Psychosexual questionnaire results also demonstrated statistically significant improvement over baseline (p<0.0001) in most parameters at Day 30 and all timepoints thereafter in both trials. On Days 180 and 365 (v. baseline) oral TU was associated with a significant reduction in fat mass [-1.92 ± 2.79 (SD) and -2.4 ± 3.6 kg, respectively] (p<0.0001) and an increase in lean body mass [+2.87 ± 2.73 and +3.15 ± 2.69 kg, respectively] (p<0.0001). Oral TU increased mean BMD over baseline on Days 180 and 365 in spine [+0.013 ± 0.035 and +0.018 ± 0.042 g/cm2, respectively (p<0.0001)] and hip [+0.006 ± 0.019 and +0.012 ± 0.023 g/cm2, respectively (p<0.0001)]. Oral TU exhibited a safety profile consistent with commonly prescribed topical T-comparators. Modest increases in cuff sBP of 2.8 ± 11.84 (SD) mm Hg and 1.8 ± 10.76 mm Hg were observed in Trial I for both oral TU and the comparator T-solution. Conclusions: Treatment of hypogonadal men with oral TU yielded circulating mean T concentrations in the mid-eugonadal range and significantly improved psychosexual, general well-being, body composition and BMD parameters comparable to transdermal T administration.


2021 ◽  
Author(s):  
Nicole B. Fritz ◽  
Pedro Gargallo ◽  
Alvaro Juesas ◽  
Jorge Flandez ◽  
Guilherme E. Furtado ◽  
...  

2021 ◽  
Author(s):  
Małgorzata Chlabicz ◽  
Marlena Paniczko ◽  
Jacek Jamiołkowski ◽  
Paweł Sowa ◽  
Małgorzata Szpakowicz ◽  
...  

Abstract Background While obesity has been correlated with welfare in the general population, there is not much data on the influence of body composition on welfare among the non-obese adult individuals. Methods A longitudinal, population-based study was conducted in 2017–2020. Body composition was assessed using Dual Energy X-ray Absorptiometry. Welfare was rated with Satisfaction with Life Scale (SWLS), Euro Quality of Life Visual Analogue Scale (EQ-VAS) and Beck Depression Inventory (BDI). Results A total of 726 non-obese individuals from general population were analyzed. The mean age was 46.8 ± 15.4 years and 42.1% of participants were male. The mean value for SWLS was 23.09 ± 5.43, for EQ-VAS was 78.0 ± 14.5, and for BDI was 6.7 ± 6.6. On SWLS the waist-hip ratio had a negative impact even after adjustment for age, gender and concomitant diseases. EQ-VAS was inversely associated with android fat distribution and directly associated with muscle mass. BDI value was inversely associated with lower muscle mass, especially of the lower limbs. The well-being of women was mainly associated with the distribution of adipose tissue and less with the distribution of muscle tissue - abdominal fat distribution has a particularly negative impact on well-being among women. In contrast, men's well-being depends more on muscle mass and to a lesser extent on the distribution of fat tissue - a positive significant effect has lean mass and a circumference of thigh below gluteal fold. Conclusions Body composition is significantly associated with welfare in non-obese population. Android type fat distribution may have a negative impact while muscle mass positive.


Sports ◽  
2020 ◽  
Vol 8 (10) ◽  
pp. 131
Author(s):  
Amy-Lee Bowler ◽  
Remco Polman

Background: Recently, a focus has been placed on investigating the potential benefits of adherence to a ketogenic diet in enhancing body composition, physical health, psychological well-being, and performance of athletes from various sporting disciplines. As the available research is yet to be collated and analyzed in a single review, this scoping review aims to analyze and draw conclusions from the available literature that exists on the efficacy of a ketogenic diet among athletic populations. Methods: Several primary research databases and any relevant citation lists were searched to locate appropriate studies for inclusion in this scoping review. Studies that investigated the effects of adherence to a ketogenic diet (KD), defined by a carbohydrate intake of less than 5% of total energy intake, on body composition, physical health, psychological well-being, and performance among an athletic population were included in the review. From 814 articles screened, 12 were identified as meeting the inclusion criteria and were included in the final scoping review. Results: Adherence to a KD has beneficial effects on body weight and fat mass. Varying effects were identified on physical health with the diet, eliciting positive effects on fat oxidation but potentially deleterious effects on stool microbiota and iron metabolism. Conflicting results were reported regarding the effects of a KD on sporting performance. Benefits were reported regarding athlete well-being following commencement of a KD, but only after week two. Conclusions: The results of this scoping review demonstrate that there are both beneficial and detrimental effects associated with adherence to a KD among athletic populations. It is understood that further research is required to make any concrete recommendations regarding a KD to athletes.


2021 ◽  
Vol 162 (27) ◽  
pp. 1089-1098
Author(s):  
Zsolt Szakály ◽  
József Bognár ◽  
Zoltán Tánczos ◽  
Csaba András Dézsi

Összefoglaló. Bevezetés: A szociális szférában dolgozók túlterheltsége jelentős, és munkakörülményeik többnyire kedvezőtlenek. Bizonyított, hogy az életcélok meghatározzák a karrier, az egészségtudatosság és az életminőség területeit, de ez utóbbi a szociális dolgozók mintáján még nem került bizonyításra. Célkitűzés: A kutatás célja, hogy bemutassa egy szociális és egészségügyi szolgáltatóintézmény női dolgozóinak (n = 127) tápláltsági és fittségi állapotát és életminőségét, valamint az életcélok meghatározó szerepét ezekre a mutatókra. Módszer: Kérdőív, teszt, testösszetétel-vizsgálat és fittségiállapot-felmérés segítségével gyűjtöttünk adatokat, amelyeket különbözőségvizsgálattal és regresszióelemzéssel elemeztünk. Eredmények: A minta tápláltsági mutatója túlsúlyra utal, míg a fittségi állapot, az életminőség és az életcélok még elfogadható tartományban vannak, de a szélsőértékek jelentősek. A magasabb életcélokkal rendelkezők jobb fittségi mutatókkal és életminőséggel jellemezhetők. Az ülőmunkát és a fizikai munkát végzők között minimális különbség volt kimutatható a tápláltsági mutatók, a fittség és az életminőség tekintetében. A táppénzt igénybe vevők gyengébb fittségi és életminőség-mutatókkal rendelkeznek, mint akik nem voltak betegszabadságon. Az életkor előrehaladtával romló testösszetételt és fittségi állapotot detektáltunk. Következtetés: A korábbi kutatási eredményeket megerősíthetjük abban, hogy a szociális dolgozók tápláltsági és fittségi mutatói, valamint életminőségszintje nem optimális. Az életcélok meghatározó szerepe a vizsgált területek számottevő részében bizonyítást nyert. A dolgozói életcélok megerősítésének egyik fontos színtere a munkahely, ahol számos pozitív hatás érhető el a testi-lelki egészség, a jóllét és a munkateljesítmény területein is. Orv Heti. 2021; 162(27): 1089–1098. Summary. Introduction: Professionals working in the social sector typically do significant overwork in rather unfavourable working conditions. Although the purpose in life is proved to determine the areas of career, health awareness, and the quality of life, the latter has not yet been confirmed among social workers. Objective: The purpose of this research is to demonstrate body composition and fitness status as well as the quality of life of female employees (n = 127) at a social institution, furthermore the decisive role purpose of life plays in these indicators. Method: Data were collected through questionnaires, tests, body composition analyses, and fitness status tests, and were assessed by t-test, analysis of variance and regression analysis. Results: Body composition of the participants indicates a generally overweight status, while fitness status, quality of life, and purpose of life are within the acceptable range, however, all with notable range values. Those with a higher-level purpose of life demonstrate better fitness indicators and higher quality of life. In terms of body composition, fitness, and quality of life, only a minor difference was found between those who do intellectual and physical type of work. Those who took sick leave demonstrated a lower level of fitness and quality of life compared to those who did not take any sick leave. Body composition and fitness status have proven to deteriorate with age. Conclusion: Previous research findings can be confirmed by stating that neither the body composition and fitness indicators, nor the quality-of-life level of social workers are optimal. The determining role of purpose in life has been proven in substantial aspects in this study. One of the focus areas of enhancing purpose in life is the workplace, where major positive impacts can be achieved in terms of the physical and mental health, well-being, and work performance. Orv Hetil. 2021; 162(27): 1089–1098.


2020 ◽  
Vol 30 (2) ◽  
pp. 101-104
Author(s):  
George Wilson ◽  
Jerry Hill ◽  
Daniel Martin ◽  
James P. Morton ◽  
Graeme L. Close

Flat jockeys in Great Britain (GB) are classified as apprentices if they are aged less than 26 years and/or have ridden less than 95 winners. To gain experience, apprentices are allocated a weight allowance of up to 7 lb (3.2 kg). Given that there is no off-season in GB flat horseracing, jockeys are required to maintain their racing weight all year round. In light of recent work determining that current apprentices are considerably heavier than previous generations and that smaller increases have been made in the minimum weight, the aim of this study was to assess if the minimum weight in GB was achievable. To make the minimum weight (50.8 kg) with the maximal weight allowance requires a body mass of ∼46.6 kg while maintaining a fat mass >2.5 kg (the lowest fat mass previously reported in weight-restricted males). Thirty-two male apprentice jockeys were assessed for body composition using dual-energy X-ray absorptiometry. The mean (SD) total mass and fat mass were 56 (2.9) kg and 7.2 (1.8) kg, respectively. Given that the lowest theoretical body mass for this group was 51.2 (2.3) kg, only one of 32 jockeys was deemed feasible to achieve the minimum weight with their current weight allowance and maintaining fat mass >2.5 kg. Furthermore, urine osmolality of 780 (260) mOsmol/L was seen, with 22 (out of 32) jockeys classed as dehydrated (>700 mOsmols/L), indicating that body mass would be higher when euhydrated. Additionally, we observed that within new apprentice jockeys licensed during this study (N = 41), only one jockey was able to achieve the minimum weight. To facilitate the goal of achieving race weight with minimal disruptions to well-being, the authors’ data suggest that the minimum weight for GB apprentices should be raised.


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