Effects of Obex in Overweight and Obese Patients

Catalysis SL

Status and phase: Completed; Phase 3; Phase 2

Conditions: Overweight; Obesity

Treatments: Dietary Supplement: Obex

Study type: Interventional

Funder types: Industry

Identifiers

NCT02145442

OBEX-IFG-2014

Details and patient eligibility

About

• Obesity is an important and growing public health worldwide
• Obesity is highly related to the development of metabolic syndrome, diabetes, cardiovascular diseases and cancer
• An extensive body of evidence from efficacy trials has shown that weight loss is achievable, however, a modest weight loss is achieved in a small proportion of patients
• Important adverse events have been reported with the use of antiobesity drugs.
• The use of natural products with potential effects inducing weight loss is an alternative strategy for treating patients with overweight and obesity. However, efficacy and safety should be evaluated in RCT.
• Obex combines different molecules with potential effects inducing weight loss and control on metabolic parameters such as fasting glucose, cholesterol and triglycerides.
• Therefore, the administration of Obex in overweight and obese patients with impaired fasting glucose could be an excellent strategy to induce weight loss and ameliorate the metabolic disturbances related to obesity and overweight.

Enrollment: 40 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Overweight and Obese subjects with and without IFG
• Ability to provide informed consent

Exclusion criteria

• Presence of diabetes mellitus, hepatic, renal or cardiovascular disease
• Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc)
• Sepsis or any other condition that could potentially interfere with treatment
• History of bariatric surgery
• Pregnancy or lactation
• Concomitant disease with reduced life expectancy
• Severe psychiatric conditions
• Anyone with chronic medical conditions requiring regular intake of any prescription medications.
• Used drugs for weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Accomplia [rimonabant], Alli [low-dose orlistat], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
• Are actively participating in, or have participated in a formal weight loss program within the last 3 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Obex

Experimental group

Description:

Obex®, two oral sachets daily during three months.

Treatment:

Dietary Supplement: Obex