Evaluation of Obex® in Overweight and Obesity

NCT03541005 | Completed Phase 3 DMC

• 1 other identifier: OBEX-CAT-2018
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Overweight; Obesity; Nutritional supplement; Weight loss; waist

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• To evaluate the effect of Obex® on Body Mass Index (BMI).

  Six months

• To evaluate the effect of Obex® on the waist and hip ratio.

  Six months

• To evaluate the effect of Obex® on the waist and height ratio.

  Six months

• To evaluate the effect of Obex® on arterial blood pressures (BP).

  Six months

• To evaluate the effect of Obex® on fasting insulin levels.

  Six months

Study Arms (2)

Obex

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Obex DIETARY_SUPPLEMENT

After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex

Obex

Placebo DIETARY_SUPPLEMENT

After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo.

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Women of childbearing age who use hormonal contraceptives (oral or injectable).
• Pregnant or breastfeeding.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

National Institute of Endocrinology

Havana, La Habana, 10400, Cuba

Location

Related Publications (1)

• Cabrera-Rode E, Cubas-Duenas I, Acosta JR, Hernandez JC, Gonzalez AIC, Calero TMG, Dominguez YA, Rodriguez JH, Rodriguez ADR, Alvarez Alvarez A, Valdes RE, Espinosa LJ, Belent OT, Benavides ZB, Estevez ES, Rodriguez YA, Del Valle Rodriguez J, Julia SM. Efficacy and safety of Obex(R) in overweight and obese subjects: a randomised, double-blind, placebo-controlled clinical trial. BMC Complement Med Ther. 2023 Feb 20;23(1):58. doi: 10.1186/s12906-023-03847-7.

  PMID: 36804035 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Roselin Valle Cabrera, BSc.

  National Coordinator Center of Clinical Trials (CENCEC)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 30, 2018
• Study Start: October 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: July 3, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CU (1)