Evaluation of Obex® in Overweight and Obesity

Efficacy and Safety of the Obex® Nutritional Supplement in Overweight and Obese Subjects: Phase III.

• Obesity is an important and growing worldwide
• Obesity is highly related to the development of metabolic syndrome, diabetes, cardiovascular diseases and cancer
• Diverse adverse events have been reported with the use of antiobesity drugs.
• Several articles describe the beneficial effect of several specific components of the Obex® supplement on weight loss, in the reduction of waist circumference, suppression of appetite, decrease fasting glucose levels, improvement of insulin sensitivity and β cells function.
• Therefore, the administration of Obex in overweight and obese patients could be an excellent strategy to induce weight loss and ameliorate the metabolic disturbances related to obesity and overweight.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Obex; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Cuba
  • La Habana
    • Havana, La Habana, Cuba, 10400
      • National Institute of Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who fulfill the diagnosis criteria of overweight or obesity (BMI ≥ 25.0 and less than 40).
• Age between 20 and 65 years old.
• Values of fasting glucose < 7.0 mmol / L and at two hours < 11.1 mmol / L during Glucose Tolerance Test (OGTT).
• Written informed consent of participation in the study.

Exclusion Criteria:

• Thyroid dysfunction (hypo or hyperthyroidism).
• Type 1 or type 2 diabetes.
• Prediabetes treated with oral agents.
• Alterations of lipids treated with drugs.
• Medicine consumption of or dietary supplements that influence the reduction of body weight.
• Consumption of steroids or prolonged use of them (last 3 months).
• Treatment with immunosuppressive drugs.
• Chronic diseases (of the hepatic, renal and cardiovascular systems, pancreatitis or some type of malignancy condition) or acute at the time of inclusion.
• Insulin resistance due to diseases such as acromegaly, endogenous hypercortisolism, polycystic ovarian syndrome or hyperprolactinemia.
• History of symptomatic hypoglycaemia.
• History of chronic debilitating diseases, anemia and collagen diseases.
• History or existence psychological illness with eating disorders or toxicity.
• History of alcoholism or drug dependence.
• Inability to comply with the instructions of the investigation.
• Severe infections at the time of inclusion.
• Women of childbearing age who use hormonal contraceptives (oral or injectable).
• Pregnant or breastfeeding.
• Known sensitivity to any of the components of the formulation
• Gynoid fat distribution.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obex; a nutritional supplement Obex® 8 g daily by oral route divided into two doses of 4g (between 15 and 20 minutes before lunch and dinner) diluted in water or juice for 6 months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise.	Dietary supplement: Obex; After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex
Placebo Comparator: Placebo; Placebo 8 g daily by oral route divided into two doses of 4g (between 15 and 20 minutes before lunch and dinner) diluted in water or juice for 6 months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise.	Dietary supplement: Placebo; After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Body Weight.	Change in body weight from baseline (0) after six months of treatment (i.e., weight at six month minus weight at baseline 0). Body weight measured in kilograms (k).	Six months
Change From Baseline in Waist Circumference at Week 24.	Change in waist circumference from baseline after six months of treatment (i.e., waist circumference at six month minus waist circumference at baseline 0). Waist measured in centimeters (cm).	Six months
To evaluate the effect of Obex® on fasting glucose levels.	The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels by blood analysis.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of Obex® on Body Mass Index (BMI).	The BMI will be measured by Quételet index.	Six months
To evaluate the effect of Obex® on the waist and hip ratio.	Waist and hip ratio will be measured according to the World Health Organisation's data gathering protocol.	Six months
To evaluate the effect of Obex® on the waist and height ratio.	Waist and height ratio will be measured.	Six months
To evaluate the effect of Obex® on arterial blood pressures (BP).	The arterial BP will be evaluated by the doctor.	Six months
To evaluate the effect of Obex® on fasting insulin levels.	The insulin levels will be evaluated by blood analysis.	Six months
To evaluate the effect of Obex® on insulin resistance.	Homeostasis model assessment-estimated insulin resistance (HOMA-IR), calculated from individual serum measures (fasting insulin x fasting glucose/22.5).	Six months
To evaluate the effect of Obex® on insulin sensitivity.	The Quicki, Bennett and Raynaud insulin sensitivity indexes will be evaluated by QUICKI = [1/[log I0 + log G0], Bennett index (BEN) = 1/(log I0 x log G0), Raynaud index (RAY) = [40/I0]).	Six months
To evaluate the effect of Obex® on β-cell function.	Homeostatic model assessment-beta cell (HOMA-β), calculated from individual serum measures (20 x fasting insulin (µU/mL)/fasting glucose (mmol/L)-3.5).	Six months
To evaluate the effect of Obex® on cholesterol.	The cholesterol, triglyceride, HDL-c and LDL-c levels will be evaluated by blood analysis.	Six months
To evaluate the effect of Obex® on hepatic enzymes.	The hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase) will be evaluated by blood analysis.	Six months
To evaluate the effect of Obex® on creatinine and uric acid concentrations.	The creatinine and uric acid levels will be evaluated by blood analysis.	Six months
To evaluate the effect of Obex® on haemoglobin levels.	The haemoglobin levels will be evaluated by blood analysis.	Six months
To evaluate the effect of Obex® on Conicity Index (CI)	CI will be measured by index.	Six months

Collaborators and Investigators

• Sponsor: Catalysis SL
• Investigators: Study Director: Roselin Valle Cabrera, BSc., National Coordinator Center of Clinical Trials (CENCEC)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): July 3, 2021

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Weight loss; Nutritional supplement; waist
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: OBEX-CAT-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No