Obex, a Nutritional Supplement, in Overweight and Obese Spanish Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Obex®, a Nutritional Supplement, in Overweight or Obese Women

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Dietary Supplement: Obex
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obex, a nutritional supplement<br>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<br>* After concluded the two months of treatment, patients will be follow-up during three months without consumption of Obex.<br>|
| Placebo Comparator: Placebo<br>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<br>* After concluded the two months of treatment, patients will be follow-up during three months without consumption of the placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, Nutritional supplement, Waist, Body composition, Skinfolds