Obex, a Nutritional Supplement, in Overweight and Obese Spanish Women
Palavras-chave
Resumo
Descrição
The nutritional supplement consists of natural plant extracts such as Caralluma fimbriata, Phaseolus vulgaris, Acai Berry and other antiobesity agents: ornithine, carnitine fumarate, essential fatty acids and certain amino acids, vitamins and minerals.
datas
| Última verificação: | 01/31/2014 |
| Enviado pela primeira vez: | 08/08/2013 |
| Inscrição estimada enviada: | 08/28/2013 |
| Postado pela primeira vez: | 09/03/2013 |
| Última atualização enviada: | 02/23/2014 |
| Última atualização postada: | 02/24/2014 |
| Data real de início do estudo: | 07/31/2013 |
| Data Estimada de Conclusão Primária: | 01/31/2014 |
| Data Estimada de Conclusão do Estudo: | 01/31/2014 |
Condição ou doença
Intervenção / tratamento
Dietary Supplement: Obex, a nutritional supplement
Drug: Placebo
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Experimental: Obex, a nutritional supplement Obex will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during two months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise. | Dietary Supplement: Obex, a nutritional supplement After concluded the two months of treatment, patients will be follow-up during three months without consumption of Obex. |
| Placebo Comparator: Placebo Placebo will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during two months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise. | Drug: Placebo After concluded the two months of treatment, patients will be follow-up during three months without consumption of the placebo. |
Critério de eleição
| Idades qualificadas para estudar | 35 Years Para 35 Years |
| Sexos elegíveis para estudo | Female |
| Aceita Voluntários Saudáveis | sim |
| Critério | Inclusion Criteria: - Women aged between 35 and 60 years. - Body Mass Index (BMI) greater than 27 kg/m² and lower than 35 kg/m² - Ability to provide informed consent Exclusion Criteria: - Presence of any endocrine, hepatic, renal or cardiovascular disease. - History of bariatric surgery - Pregnancy or lactation - Concomitant disease with reduced life expectancy - Severe psychiatric conditions - Drug dependence |
Resultado
Medidas de Resultado Primário
1. To evaluate the effect of OBEX on skinfolds [Two months of treatment and three months after concluded the treatment]
Medidas de Resultado Secundário
1. To evaluate the effect of OBEX on the waist and hip circumferences [Two months of treatment and three months after concluded the treatment]
2. To evaluate the effect of Obex on the arm circumference. [Two months of treatment and three months after concluded the treatment]
3. To evaluate the effect of Obex on the percentage of body fat [Two months of treatment and three months after concluded the treatment]
4. To evaluate the effect of Obex on the muscular mass [Two months of treatments and three months after concluded the treatment]
5. To evaluate the effect of Obex on arterial blood pressures. [Two months of treatment and three months after concluded the treatment]
6. To evaluate the effect of Obex on fasting glucose and cholesterol levels [Two months of treatment and three months after concluded the treatment]
