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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934036
• Other study ID #: HOPE_TRIAL1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 9, 2013
• Last updated: February 24, 2014
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Seguridad Alimentaria y Nutrición
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Obex
After concluded the two months of treatment, patients will be follow-up during three months without consumption of Obex.

Drug:
• Placebo
After concluded the two months of treatment, patients will be follow-up during three months without consumption of the placebo.

Locations

Country	Name	City	State
Spain	Universidad Autónoma de Madrid	Ciudad Universitaria de Cantoblanco	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No