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

Phase 2

Completed

• Conditions: Obesity; Overweight
• Interventions: Dietary Supplement: Obex; Drug: Placebo

• Registration Number: NCT01934036
• Lead Sponsor: Catalysis SL

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-04
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obex, a nutritional supplement	Obex	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	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.

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of OBEX on skinfolds	Two months of treatment and three months after concluded the treatment	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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of OBEX on the waist and hip circumferences	Two months of treatment and three months after concluded the treatment	Waist and Hip circumferences will be measured at baseline and at the end of treatment.
To evaluate the effect of Obex on the arm circumference.	Two months of treatment and three months after concluded the treatment	The arm circumference will be measured at baseline and at the end of treatment.
To evaluate the effect of Obex on the percentage of body fat	Two months of treatment and three months after concluded the treatment	Body fat (%) will be assessed at baseline and the end of treatment
To evaluate the effect of Obex on the muscular mass	Two months of treatments and three months after concluded the treatment	The muscular mass will be measured at baseline and at the end of treatment.
To evaluate the effect of Obex on arterial blood pressures.	Two months of treatment and three months after concluded the treatment	The arterial BP will be evaluated at baseline and at the end of treatment.
To evaluate the effect of Obex on fasting glucose and cholesterol levels	Two months of treatment and three months after concluded the treatment	The fasting glucose and cholesterol levels will be evaluated at baseline and at the end of treatment.

Trial Locations

Locations (1)

Universidad Autónoma de Madrid; 🇪🇸 Ciudad Universitaria de Cantoblanco, Madrid, Spain