Overweight and ObesityPhase 3NCT03541005
Evaluation of Obex® in Overweight and Obesity
A Phase 3 study testing Obex in people with Overweight and Obesity, run by Catalysis SL at 1 site in Cuba.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Obex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteCuba
- Study dates
- 1 Oct 2018to 3 Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Overweight and Obesity
- Being tested
- Obex, Placebo
- Keywords
- Overweight, Obesity, Nutritional supplement, Weight loss, waist
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObexDietary supplement
After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex
PlaceboDietary supplement
After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: Six months
Secondary outcomes (13)
To evaluate the effect of Obex® on Body Mass Index (BMI).
The BMI will be measured by Quételet index.
Measured: 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.
Measured: Six months
To evaluate the effect of Obex® on the waist and height ratio.
Waist and height ratio will be measured.
Measured: Six months
To evaluate the effect of Obex® on arterial blood pressures (BP).
The arterial BP will be evaluated by the doctor.
Measured: Six months
To evaluate the effect of Obex® on fasting insulin levels.
The insulin levels will be evaluated by blood analysis.
Measured: 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).
Measured: 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]).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six months
To evaluate the effect of Obex® on haemoglobin levels.
The haemoglobin levels will be evaluated by blood analysis.
Measured: Six months
To evaluate the effect of Obex® on Conicity Index (CI)
CI will be measured by index.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 Oct 2018
- Primary completion1 Sep 2019
- Study completion3 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roselin Valle Cabrera, BSc., Study director, National Coordinator Center of Clinical Trials (CENCEC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541005
- Sponsor's protocol ID
- OBEX-CAT-2018
- Status last verified
- Oct 2021
- First submitted
- 3 May 2018
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 36804035
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Obex® Nutritional Supplement in Overweight and Obese Subjects: Phase III.
- ClinicalTrials.gov ID
- NCT03541005
- Acronym / sponsor ID
- OBEX-CAT-2018
- Conditions
- Overweight and Obesity
- Keywords
- Overweight, Obesity, Nutritional supplement, Weight loss, waist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 3 Jul 2021 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obex | Experimental | Dietary Supplement: Obexa 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 | Placebo comparator | Dietary Supplement: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObexAfter concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex | Dietary supplement | Obex |
| PlaceboAfter concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo. | Dietary supplement | Placebo |
Primary outcome
Change From Baseline in Body Weight.
Time frame: Six months
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.
Time frame: Six months
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.
Time frame: Six months
The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels by blood analysis.
13 secondary outcomes
To evaluate the effect of Obex® on Body Mass Index (BMI).
Time frame: Six months
To evaluate the effect of Obex® on the waist and hip ratio.
Time frame: Six months
To evaluate the effect of Obex® on the waist and height ratio.
Time frame: Six months
To evaluate the effect of Obex® on arterial blood pressures (BP).
Time frame: Six months
To evaluate the effect of Obex® on fasting insulin levels.
Time frame: Six months
To evaluate the effect of Obex® on insulin resistance.
Time frame: Six months
To evaluate the effect of Obex® on insulin sensitivity.
Time frame: Six months
To evaluate the effect of Obex® on β-cell function.
Time frame: Six months
To evaluate the effect of Obex® on cholesterol.
Time frame: Six months
To evaluate the effect of Obex® on hepatic enzymes.
Time frame: Six months
To evaluate the effect of Obex® on creatinine and uric acid concentrations.
Time frame: Six months
To evaluate the effect of Obex® on haemoglobin levels.
Time frame: Six months
To evaluate the effect of Obex® on Conicity Index (CI)
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Derived from this study: PubMed 36804035Cabrera-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roselin Valle Cabrera, BSc. study director
National Coordinator Center of Clinical Trials (CENCEC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Obex in people with Overweight and Obesity, run by Catalysis SL at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Body Weight. (time frame: Six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03541005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.