Obex® - Overweight and Obese - Adults - Phase III | Registro Público Cubano de Ensayos Clínicos

Obex® - Overweight and Obese - Adults - Phase III

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Efficacy and safety of the Obex® nutritional supplement in overweight and obese subjects. Phase III

Secondary indentifying numbers:

CAT-2017-5

Issuing authority of the secondary identifying numbers:

National Coordinator Center of Clinical Trials (CENCEC)

Source(s) of monetary or material support:

Catalysis, S.L. laboratory Cuban Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Trials notification

Regulatory instance:

Institute of Nutrition and Hygiene of food(INHA)

Notification date :

21/02/2018

Reference number:

Not applicable

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Eduardo

Last name:

Cabrera Rode

Medical Specialty :

Bachelor of Biology, Doctor of Biological Sciences

Affiliation:

National Institute of Endocrinology

Postal address:

Zapata and C Vedado

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78320362

+53-78329707

Email address:

diabetes@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

National Institute of Endocrinology, January 19, 2018

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

02/05/2018

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Obesity

Health condition(s) code:

Obesity

Overnutrition

Nutrition Disorders

Nutritional and Metabolic Diseases

Overweight

Body Weight

Intervention(s):

Group A (Experimental): 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. Group B (Control): Placebo 8 g daily by oral route divided into two doses of 4g (between 15 and 20minutes before lunch and dinner) diluted in water or juice for 6 months.

Intervention code:

Dietary Supplements

Placebo

Administration, Oral

Intervention keyword:

Obex

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Weight (Value in kg). Measurement time: At baseline, 3, 6, 9 and, 12 months. Waist circumference (value in cm). Measurement time: At baseline, 3, 6, 9 and, 12 months.

Key secondary outcomes:

Efficacy outcomes: 1. Measurements and anthropometric indexes. Measurement time: at baseline, 3, 6 and, 12 months. It will measure by: -Body Max Index-BMI (Weight/(Height*Height). The weight expressed in Kg and, the height expressed in meters) - Hip circumference (Value expressed in cm) - Waist-hip Index (Waist circumference/Hip circumference. All values are expressed in cm) - Waist- Height Index (Waist circumference/Height. All values are expressed in cm - Conicity Index (Waist circumference in cm/(0.109*square root of (weight in kg/height in cm))) 2. Glucose on an empty stomach and at two hours after an oral glucose tolerance test (Value expressed in mmol/L). Measurement time: at baseline, 6 and, 12 months. 3. Hemoglobin (Value expressed in g/L). Measurement time: at baseline, 6 and, 12 months. 4. Hemoglobina glucosilada -HbA1c (Value expressed in %). Measurement time: at baseline, 6 and, 12 months. 5. Fasting insulin (Value expressed in μU/ml). Measurement time: at baseline, 6 and, 12 months. 6. Insulin resistance indexes. - HOMA-IR will be calculated by the homeostatic model of Mathews - HOMA-β will be determined by the homeostatic model (HOMA) of Mathew - QUICKI Index calculated as [1/[log insulin0 + log glucose0] - Bennett Index calculated as [40/insulin0] - Raynaud Index calculated as 1/(log insulin0 x log glucose0) 7. Biochemistry test (Triglycerides, Cholesterol, HDL-c, LDL-c, TGP; TGO, GGT, Uric acid, Creatinine in μmol/L). Measurement time: at baseline, 6 and, 12 months. 8. Blood Pressure (Systolic and Diastolic blood pressure expressed in mmHg).Measurement time: at baseline, 3, 6, 9 and, 12 months. Safety outcomes: 9. Adverse Events-AE. Measurement time: at baseline, 1 ½ month (6 weeks), 3 months, 4 ½ months (20 weeks), 6 months, 9 months and, 12 months. - Occurrence of some AE in the subject (Yes, No). -Type of AE (description of EA using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0) - Intensity of the AE (Light, Moderate, Severe according to 45/2007 CECMED regulation) - Seriousness of the AE (Serious, Not serious) - Duration of the AE (Time from event start until stop the event) - Attitude regarding the treatment under study (No changes, Dose modification, Treatment temporary interruption, Treatment definitive interruption) - Result of the AE (Recovered, Improved, Persists, Squeals) - Causality relationship (Very likely, Probable, Possible, Unlikely, Not related, Not evaluable) -Treatment indicated for the AE (Specify the treatment for every AE)

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

20 years

Maximum age:

65 years

Inclusion criteria:

1. Patients who fulfill the diagnosis criteria of overweight or obesity 2. Age between 20 and 65 years old. 3. Values of fasting glycemia <7.0 mmol / L and at two hours <11.1 mmol / L during PTG-O. 4. Written informed consent of participation in the study 5. BMI ≥ 25.0 and less than 40

Exclusion criteria:

1. Thyroid dysfunction (hypo or hyperthyroidism). 2. Type 1 or type 2 diabetes. 3. Prediabetes treated with oral agents. 4. Alterations of lipids treated with drugs. 5. Medicine consumption of or dietary supplements that influence the reduction of body weight. 6. Consumption of steroids or prolonged use of them (last 3 months). 7. Treatment with immunosuppressive drugs. 8. Chronic diseases (of the hepatic, renal and cardiovascular systems, pancreatitis or some type of malignancy condition) or acute at the time of inclusion. 9. Insulin resistance due to diseases such as acromegaly, endogenous hypercortisolism, polycystic ovarian syndrome or hyperprolactinemia. 10. History of symptomatic hypoglycaemia 11. History of chronic debilitating diseases, anemia and collagen diseases. 11. History or existence psychological illness with eating disorders or toxicity. 12. History of alcoholism or drug dependence. 13. Inability to comply with the instructions of the investigation. 14. Severe infections at the time of inclusion. 15. Women of childbearing age who use hormonal contraceptives (oral or injectable). 16. Pregnant or breastfeeding. 17. Known sensitivity to any of the components of the formulation

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

3

Target sample size:

160

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Roselin

Last Name:

Valle Cabrera

Specialty:

Bachelor degree in Pharmaceutical Sciences. Master in Clinical Pharmacy. Master in Clinical Trials

Affiliation:

National Coordinator Center of Clinical Trials (CENCEC)

Postal Address:

5ta A entre 60 y 62. Miramar, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164224

Email :

roselin@cencec.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Eduardo

Last Name:

Cabrera Rode

Specialty:

Bachelor of Biology, Doctor of Biological Sciences

Affiliation:

National Institute of Endocrinology

Postal Address:

Zapata y C Vedado

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-7832 0362, +53-78329707

Email :

diabetes@infomed.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000267

Date of Registration in Primary Registry:

17/04/2018

Record Verification Date:

2020/12/21

Next update date:

2021/12/21

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Obex® - Overweight and Obese - Adults - Phase III

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