RESUMO
BACKGROUND: Studies have demonstrated that women with low desire and low excitement have negative feelings regarding their physical and emotional satisfaction, as well as their happiness. In this study, we evaluate the efficacy of Libicare® - a multi-ingredient food supplement - to improve sexual function in postmenopausal women. METHODS: This was an exploratory, prospective, non-controlled, observational study. Postmenopausal women aged 45-65 with a risk of sexual dysfunction (Female Sexual Function Index (FSFI) < 25.83) were included during routine clinical visits and treated with 2 tablets of Libicare® daily for 2 months. Libicare® is an oral food supplement containing Trigonella foenum graecum, Turnera diffusa, Tribulus terrestris, and Ginkgo biloba dry extracts. Primary endpoint: change vs. baseline in FSFI score. Secondary endpoints: 1) changes in testosterone and serum steroid levels of free testosterone and sex hormone-binding globulin (SHBG) levels and 2) tolerability. RESULTS: A total of 29 patients (mean age: 54.69 years) were included. FSFI mean (SD) score showed a significant increase: 20.15 (4.48) vs 25.03 (6.94), baseline vs final; p = 0.0011, paired t-test. Most patients (86.2%) increased their FSFI score. All FSFI domains, except dyspareunia, showed significant increases. The highest increase was observed in the desire domain (p = 0.0004). Testosterone and SHBG levels were assessed in 21 patients. A significant increase in testosterone level was observed: 0.41 (0.26) vs. 0.50 (0.34) pg/mL, baseline vs. final; p = 0.038, Wilcoxon test. 52.4% of patients increased their testosterone levels. Finally, a significant decrease was observed in SHBG level: 85 (32.9) vs. 73 (26.8) nmol/L, baseline vs. final; p = 0.0001; paired t-test. 95.2% of patients decreased their SHBG levels. CONCLUSION: In this pilot study, a significant improvement in sexual function and related hormone levels was observed with Libicare®. Further studies must be conducted to confirm these exciting results. TRIAL REGISTRATION: Current Controlled Trial ISRCTN12928573 . Date of registration: 28/March/2019. Retrospectively registered.
Assuntos
Suplementos Nutricionais , Preparações de Plantas/administração & dosagem , Disfunções Sexuais Fisiológicas/tratamento farmacológico , Disfunções Sexuais Psicogênicas/tratamento farmacológico , Feminino , Ginkgo biloba , Humanos , Libido/efeitos dos fármacos , Pessoa de Meia-Idade , Satisfação Pessoal , Projetos Piloto , Extratos Vegetais/administração & dosagem , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is a significant health problem for which there is no universally accepted pharmacological treatment. The combination of weight loss and antioxidant drugs to ameliorate insulin resistance and improve steatosis, inflammation and fibrosis provides the rational for therapeutic trials. AIM: To evaluate the efficacy and safety of a nutritional supplement Viusid in association with diet and exercise for NAFLD. METHODS: A randomized, controlled and parallel-group trial was conducted at a tertiary care academic centre (National Institute of Gastroenterology, Havana, Cuba). We randomly assigned 60 patients with liver biopsy-proven NAFLD to 6 months of treatment with a hypocaloric diet plus aerobic exercise daily and three Viusid sachets daily or a hypocaloric diet and exercise. Endpoints were improvement in the NAFLD activity score (NAS), fibrosis and normalization of serum aminotransferase levels. RESULTS: A significant improvement in steatosis, necroinflammation and fibrosis was seen in each group of treatment (P < 0.01 for each feature). The Viusid group, as compared with the control group, significantly reduced the mean of NAS [from 4.18 to 0.54 points in the Viusid group vs. 4.45 to 2.2 points in the control group (P < 0.001)]. On between-group comparison, Viusid was found to be associated with a significantly greater improvement in steatosis (P < 0.001), ballooning (P = 0.002) and lobular inflammation (P = 0.025), but not in fibrosis (P = 0.07). Viusid was well tolerated. CONCLUSIONS: Our results indicate that treatment with diet and exercise leads to a notable improvement in the histological features of NAFLD; however, the administration of Viusid intensifies the improvements of histological findings, especially of steatosis and inflammation.
Assuntos
Suplementos Nutricionais , Terapia por Exercício , Fígado Gorduroso/dietoterapia , Adolescente , Adulto , Idoso , Glicemia/metabolismo , Terapia Combinada/métodos , Cuba , Fígado Gorduroso/sangue , Fígado Gorduroso/patologia , Feminino , Fibrose/terapia , Humanos , Resistência à Insulina , Masculino , Pessoa de Meia-Idade , Transaminases/sangue , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: To evaluate the nutritional impact of the ingestion of a fortified whole milk in children. MATERIAL AND METHODS: Prospective, longitudinal assay in 227 children aged 8-60 months. INTERVENTION: Daily consumption of 500 ml of fortified milk during 90 days. We registered milk acceptance and assessed weight, height; hemoglobin, serum iron, vitamin B12, and folic acid, at the beginning and the end of the study. Statistical evaluation were done with central and dispersion indices in the dimensional variables, using Student's t test and chi 2 test for compare nominal variables at initial and the end of the study. RESULTS: At admission, 45 children were malnourished and 36 were anemic. At the end of the supplementation period there was a reduction to 35 malnourished (p < 0.21) and 18 anemic (p < 0.01). Anthropometric weight/height score in Z at the beginning and end of the study (x +/- S.D) were -0.35 +/- 0.88 vs -0.14 +/- 9 (p < 0.01); Hb g/dl: 11 +/- 1.3 vs 11.9 +/- 1.9 (p < 0.001), Iron mg/dl: 108 +/- 44 vs 115 +/- 31 (p = 0.06) and vitamin B12 pg/ml: 649 +/- 494 to 1053 +/- 854 (p < 0.001). The milk was well tolerated and widely accepted. CONCLUSIONS: The consumption of a fortified whole milk during 90 days improved significantly the nutritional status of the children, the weight for height Z score, the plasma level of vitamin B12 and Hb, and decreased the number of anemic and malnourished children.
Assuntos
Anemia/dietoterapia , Alimentos Fortificados , Fenômenos Fisiológicos da Nutrição do Lactente , Leite , Distúrbios Nutricionais/dietoterapia , Animais , Pré-Escolar , Humanos , Lactente , Minerais/administração & dosagem , Estado Nutricional , Estudos Prospectivos , Vitaminas/administração & dosagemRESUMO
Globulol, sabinene, caryophyllene, and caryophyllene epoxide have been isolated and identified in the essential oil of A. GRATISSIMA flowers from plants growing in Uruguay.