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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01934036

Enrollment

Registered

2013-09-04

Start date

2013-08-31

Completion date

2014-02-28

Last updated

2014-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Weight loss, Nutritional supplement, Waist, Body composition, Skinfolds

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.

Interventions

DIETARY_SUPPLEMENTObex

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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.
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026