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

Phase 3CompletedNCT01934036

Catalysis SL92 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obesity Overweight

Interventions

ObexDIETARY_SUPPLEMENT

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

PlaceboDRUG

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

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Universidad Autónoma de Madrid

Ciudad Universitaria de Cantoblanco, Madrid, Spain

Outcomes

Primary Outcomes

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.