Obex, a Nutritional Supplement, in Overweight and Obese Spanish Women
Klíčová slova
Abstraktní
Popis
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.
Termíny
| Poslední ověření: | 01/31/2014 |
| První předloženo: | 08/08/2013 |
| Odhadovaná registrace vložena: | 08/28/2013 |
| První zveřejnění: | 09/03/2013 |
| Poslední aktualizace byla odeslána: | 02/23/2014 |
| Poslední aktualizace zveřejněna: | 02/24/2014 |
| Aktuální datum zahájení studie: | 07/31/2013 |
| Odhadované datum dokončení primární: | 01/31/2014 |
| Odhadované datum dokončení studie: | 01/31/2014 |
Stav nebo nemoc
Intervence / léčba
Dietary Supplement: Obex, a nutritional supplement
Drug: Placebo
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| 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. |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 35 Years Na 35 Years |
| Pohlaví způsobilá ke studiu | Female |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | 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 |
Výsledek
Primární výsledná opatření
1. To evaluate the effect of OBEX on skinfolds [Two months of treatment and three months after concluded the treatment]
Měření sekundárních výsledků
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]
