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Completed

NCT Number: NCT01934036

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

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

35 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Universidad Autónoma de Madrid

Ciudad Universitaria de Cantoblanco, Madrid, 28049, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obex

Dietary Supplement

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

Placebo

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 4, 2013
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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