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Effects of Obex in Overweight and Obese Patients

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ClinicalTrials.gov Identifier: NCT02145442
Recruitment Status : Completed
First Posted : May 23, 2014
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Catalysis SL

Brief Summary:
  • 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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Dietary Supplement: Obex Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects and Safety of Obex in Overweight and Obese Subjects With or Without Impaired Fasting Glucose
Study Start Date : June 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: Obex
Obex®, two oral sachets daily during three months.
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.




Primary Outcome Measures :
  1. To evaluate the effect of Obex® on fasting glucose levels [ Time Frame: Three months of treatment ]
    The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels

  2. To determine the safety of serious supplement-related adverse events [ Time Frame: Three months of treatment ]
    Adverse events will be evaluated during the three months of treatment


Secondary Outcome Measures :
  1. To evaluate the effect of Obex® on fasting insulin levels [ Time Frame: Three months of treatment ]
    The insulin levels will be evaluated at baseline and at the end of treatment.

  2. • To evaluate the effect of Obex® on insulin sensitivity by homeostasis model assessment-estimated insulin resistance (HOMA-IR), calculated from individual serum measures (fasting insulin x fasting glucose/22.5) [ Time Frame: Three months of treatment ]
    The HOMA-IR will be evaluated at baseline and at the end of treatment.

  3. To evaluate the effect of Obex® on insulin sensitivity by quantitative insulin sensitivity check index, Bennett and Raynaud insulin sensitivity indexes [ Time Frame: Three months of treatment ]

    The Quicki, Bennett and Raynaud insulin sensitivity indexes will be evaluated at baseline and at the end of treatment.

    QUICKI = [1/[log I0 + log G0], Bennett index (BEN) = 1/(log I0 x log G0), Raynaud index (RAY) = [40/I0])


  4. • To evaluate the effect of Obex® on β-cell function by homeostatic model assessment-beta cell (HOMA-β), calculated from individual serum measures (20 x fasting insulin (µU/mL)/fasting glucose (mmol/L)-3.5) [ Time Frame: Three months of treatment ]
    The HOMA-B will be evaluated at baseline and at the end of treatment

  5. • To evaluate the effect of Obex® on cholesterol, triglyceride and high density lipoprotein cholesterol levels (HDL-c) [ Time Frame: Three months of treatment ]
    The cholesterol, triglyceride and HDL-c levels will be evaluated at baseline and at the end of treatment.

  6. To evaluate the effect of Obex® on Glycosylated Hemoglobin (HbA1c) [ Time Frame: Three months of treatment ]
    The HbA1c will be evaluated at baseline and at the end of treatment.

  7. To evaluate the effect of Obex® on the body weight. [ Time Frame: Three months of treatment ]
    The body weight will be measured at baseline and at the end of treatment.

  8. • To evaluate the effect of Obex® on Body Mass Index (BMI) and Conicity Index (CI) [ Time Frame: Three months of treatment ]
    The BMI and CI will be measured at baseline and at the end of treatment.

  9. To evaluate the effect of Obex® on the waist and hip circumferences [ Time Frame: Three months of treatment ]
    Waist and Hip circumferences will be measured at baseline and at the end of treatment.

  10. To evaluate the effect of Obex® on arterial blood pressures (BP) [ Time Frame: Three months of treatment ]
    The arterial BP will be evaluated at baseline and at the end of treatment.

  11. • To evaluate the effect of Obex® on hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase) [ Time Frame: Three months of treatment ]
    The hepatic enzymes will be evaluated at baseline and at the end of treatment.

  12. To evaluate the effect of Obex® on creatinine and uric acid concentrations [ Time Frame: Three months of treatment ]
    The creatinine and uric acid levels will be evaluated at baseline and at the end of treatment.

  13. To evaluate the effect of Obex® on haemoglobin and serum iron levels [ Time Frame: Three months of treatment ]
    The haemoglobin and iron levels will be evaluated at baseline and at the end of treatment.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145442


Locations
Cuba
National Institute of Endocrinology
Plaza de la Revolución, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Eduardo Cabrera, M.D., Ph.D. National Institute of Endocrinology, Havana, Cuba

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT02145442     History of Changes
Other Study ID Numbers: OBEX-IFG-2014
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by Catalysis SL:
Impaired fasting glucose
Prediabetes
Obesity
Overweight
Insulin sensitivity
Weight loss
Nutritional supplement
Waist
Body composition

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms