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

February 24, 2014 updated by: Catalysis SL

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Ciudad Universitaria de Cantoblanco, Madrid, Spain, 28049
        • Universidad Autonoma de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the effect of OBEX on skinfolds
Time Frame: 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.
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
Time Frame: 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.
Two months of treatment and three months after concluded the treatment
To evaluate the effect of Obex on the arm circumference.
Time Frame: 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.
Two months of treatment and three months after concluded the treatment
To evaluate the effect of Obex on the percentage of body fat
Time Frame: Two months of treatment and three months after concluded the treatment
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
Time Frame: 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.
Two months of treatments and three months after concluded the treatment
To evaluate the effect of Obex on arterial blood pressures.
Time Frame: 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.
Two months of treatment and three months after concluded the treatment
To evaluate the effect of Obex on fasting glucose and cholesterol levels
Time Frame: 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.
Two months of treatment and three months after concluded the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Consuelo Prado, Ph.D., Universidad Autonónoma de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 9, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Estimate)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOPE_TRIAL1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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