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

NCT ID: NCT01934036

Last Updated: 2014-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-02-28

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.

Conditions

Obesity; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Obex

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Obex

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Catalysis SL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Consuelo Prado, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad Autonónoma de Madrid

Locations

Universidad Autónoma de Madrid

Ciudad Universitaria de Cantoblanco, Madrid, Spain

Countries

Spain

Other Identifiers

HOPE_TRIAL1

Identifier Type: -

Identifier Source: org_study_id