Trial | NCT02145442  Report issue

Title

Effects of Obex in Overweight and Obese Patients
Effects and Safety of Obex in Overweight and Obese Subjects With or Without Impaired Fasting Glucose

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
Study Started
Jun 30
2014
Primary Completion
Jul 31
2014
Study Completion
Nov 30
2014
Last Update
May 08
2018

Dietary Supplement Obex

Obex® will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during three months. Participants will be not trained about changes of lifestyle on their diets, or physical activity.

Obex Experimental

Obex®, two oral sachets daily during three months.

  • Dietary Supplement Obex

Criteria 

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
No Results Posted