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The aim of the study is to evaluate the effects of a dietary supplement (Obex®) on anthropometric and physiological variables in Spanish women between 35 and 60 years who are overweight or obese.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obex, a nutritional supplement | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obex | Dietary Supplement | After concluded the two months of treatment, patients will be follow-up during three months without consumption of Obex. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of OBEX on skinfolds | The primary outcome is to evaluate the effect of the treatment with OBEX on skinfold thickness of the biceps, triceps, subscapular and suprailiac as compared to placebo group at 2 months of treatment. | Two months of treatment and three months after concluded the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of OBEX on the waist and hip circumferences | Waist and Hip circumferences will be measured at baseline and at the end of treatment. | Two months of treatment and three months after concluded the treatment |
| To evaluate the effect of Obex on the arm circumference. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Consuelo Prado, Ph.D. | Universidad Autonónoma de Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Autónoma de Madrid | Ciudad Universitaria de Cantoblanco | Madrid | 28049 | Spain |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Drug | After concluded the two months of treatment, patients will be follow-up during three months without consumption of the placebo. |
|
The arm circumference will be measured at baseline and at the end of treatment. |
| Two months of treatment and three months after concluded the treatment |
| To evaluate the effect of Obex on the percentage of body fat | Body fat (%) will be assessed at baseline and the end of treatment | Two months of treatment and three months after concluded the treatment |
| To evaluate the effect of Obex on the muscular mass | The muscular mass will be measured at baseline and at the end of treatment. | Two months of treatments and three months after concluded the treatment |
| To evaluate the effect of Obex on arterial blood pressures. | The arterial BP will be evaluated at baseline and at the end of treatment. | Two months of treatment and three months after concluded the treatment |
| To evaluate the effect of Obex on fasting glucose and cholesterol levels | The fasting glucose and cholesterol levels will be evaluated at baseline and at the end of treatment. | Two months of treatment and three months after concluded the treatment |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |