Back to resultsEvaluation of Obex® in Overweight and Obesity
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Phase 3
Locations
Cuba
Study Type
Interventional
Intervention
Obex
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring Overweight, Obesity, Nutritional supplement, Weight loss, waist
Eligibility Criteria
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.
Sites / Locations
- National Institute of Endocrinology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Obex
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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).
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.
Secondary Outcome Measures
To evaluate the effect of Obex® on Body Mass Index (BMI).
The BMI will be measured by Quételet index.
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.
To evaluate the effect of Obex® on the waist and height ratio.
Waist and height ratio will be measured.
To evaluate the effect of Obex® on arterial blood pressures (BP).
The arterial BP will be evaluated by the doctor.
To evaluate the effect of Obex® on fasting insulin levels.
The insulin levels will be evaluated by blood analysis.
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).
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]).
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).
To evaluate the effect of Obex® on cholesterol.
The cholesterol, triglyceride, HDL-c and LDL-c levels will be evaluated by blood analysis.
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.
To evaluate the effect of Obex® on creatinine and uric acid concentrations.
The creatinine and uric acid levels will be evaluated by blood analysis.
To evaluate the effect of Obex® on haemoglobin levels.
The haemoglobin levels will be evaluated by blood analysis.
To evaluate the effect of Obex® on Conicity Index (CI)
CI will be measured by index.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03541005
Brief Title
Evaluation of Obex® in Overweight and Obesity
Official Title
Efficacy and Safety of the Obex® Nutritional Supplement in Overweight and Obese Subjects: Phase III.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
July 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Overweight, Obesity, Nutritional supplement, Weight loss, waist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obex
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Obex
Intervention Description
After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo.
Primary Outcome Measure Information:
Title
Change From Baseline in Body Weight.
Description
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).
Time Frame
Six months
Title
Change From Baseline in Waist Circumference at Week 24.
Description
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).
Time Frame
Six months
Title
To evaluate the effect of Obex® on fasting glucose levels.
Description
The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels by blood analysis.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
To evaluate the effect of Obex® on Body Mass Index (BMI).
Description
The BMI will be measured by Quételet index.
Time Frame
Six months
Title
To evaluate the effect of Obex® on the waist and hip ratio.
Description
Waist and hip ratio will be measured according to the World Health Organisation's data gathering protocol.
Time Frame
Six months
Title
To evaluate the effect of Obex® on the waist and height ratio.
Description
Waist and height ratio will be measured.
Time Frame
Six months
Title
To evaluate the effect of Obex® on arterial blood pressures (BP).
Description
The arterial BP will be evaluated by the doctor.
Time Frame
Six months
Title
To evaluate the effect of Obex® on fasting insulin levels.
Description
The insulin levels will be evaluated by blood analysis.
Time Frame
Six months
Title
To evaluate the effect of Obex® on insulin resistance.
Description
Homeostasis model assessment-estimated insulin resistance (HOMA-IR), calculated from individual serum measures (fasting insulin x fasting glucose/22.5).
Time Frame
Six months
Title
To evaluate the effect of Obex® on insulin sensitivity.
Description
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]).
Time Frame
Six months
Title
To evaluate the effect of Obex® on β-cell function.
Description
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
Six months
Title
To evaluate the effect of Obex® on cholesterol.
Description
The cholesterol, triglyceride, HDL-c and LDL-c levels will be evaluated by blood analysis.
Time Frame
Six months
Title
To evaluate the effect of Obex® on hepatic enzymes.
Description
The hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase) will be evaluated by blood analysis.
Time Frame
Six months
Title
To evaluate the effect of Obex® on creatinine and uric acid concentrations.
Description
The creatinine and uric acid levels will be evaluated by blood analysis.
Time Frame
Six months
Title
To evaluate the effect of Obex® on haemoglobin levels.
Description
The haemoglobin levels will be evaluated by blood analysis.
Time Frame
Six months
Title
To evaluate the effect of Obex® on Conicity Index (CI)
Description
CI will be measured by index.
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roselin Valle Cabrera, BSc.
Organizational Affiliation
National Coordinator Center of Clinical Trials (CENCEC)
Official's Role
Study Director
Facility Information:
Facility Name
National Institute of Endocrinology
City
Havana
State/Province
La Habana
ZIP/Postal Code
10400
Country
Cuba
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluation of Obex® in Overweight and Obesity
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