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

Catalysis SL

Status and phase: Completed; Phase 3; Phase 2

Conditions: Overweight; Obesity

Treatments: Dietary Supplement: Obex; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01934036

HOPE_TRIAL1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups, including a placebo group

Obex, a nutritional supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Obex

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo