Metabolic SyndromePhase 2NCT02629627
Conjugated Linoleic Acid / Leucine Versus Metformin on Visceral Fat in Metabolic Syndrome
A Phase 2 study testing Conjugated linoleic acid/Leucine and Metformin in people with Metabolic Syndrome, run by Centro Universitario de Ciencias de la Salud, Mexico.
Trial summary
In Mexico, obesity is a major public health problem. In recent years he has presented a considerable increase in the population. As a result, it has triggered a proportional increase in the incidence of cardiovascular disease and the development of Metabolic Syndrome (METS). Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Conjugated linoleic acid/Leucine and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Oct 2017
- Phase
- Phase 2
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of metabolic syndrome by IDF criteria:
- Central obesity (defi ned as waist circumference* with ethnicity specifi c values)≥80 cm in females and ≥90 cm in males
- plus any two of the following four factors:
- Raised triglycerides ≥ 150 mg/dL (1.7 mmol/L) or specific treatment for this lipid abnormality Reduced HDL colesterol
- < 40 mg/dL (1.03 mmol/L) in males < 50 mg/dL (1.29 mmol/L) in females or specifi c treatment for this lipid abnormality
- Raised blood pressure systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension
Show all 9Show fewer
- Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes
- Stable body weight in the last 3 months
- Written informed consent
Who cannot join
- Ascitis
- With previous abdominal surgery
- Pathologies that course with abdominal wall edema fluid retention
- Paniculitis of reumatic origin or any other ethiology
- Reumatic pathologies
- Metalic prothesis
- Previous known allergy to any of the ingredients that make up the active treatments assigned
- Known problem of fat absortion, esteatorrea, lipase deficiency, malabsortion of intestinal problems, CUCI
About this study
Official title: Effect of the Administration of Conjugated Linoleic Acid / Leucine Plus Metformin on Visceral Fat in Patients With Metabolic Syndrome
In Mexico, obesity is a major public health problem. In recent years he has presented a considerable increase in the population. As a result, it has triggered a proportional increase in the incidence of cardiovascular disease and the development of Metabolic Syndrome (METS). Abdominal obesity is one of the main components of METS which is generally associated with insulin resistance / hyperinsulinemia. This is influenced both by the subcutaneous adipose tissue as visceral adipose tissue. There is evidence that the visceral fat has an important bearing on many factors of METS, like: glucose intolerance, hypertension, dyslipidemia, and insulin resistance.
For management it requires a multidisciplinary approach, including changes in lifestyle, psychological and nutritional intervention as well as pharmacological and non-pharmacological support.
Among non-pharmacological therapies, there is recently the use of Conjugated Linoleic Acid (ACL) and leucine where in its assigned properties include weight reduction, anti-atherogenic , hypocholesterolemic and immunostimulant effect and anticarcinogenic properties. Regarding weight reduction dominates the mechanism of action anti-lipolytic effect. But, studies are needed to link this consumption with the increase or decrease on visceral fat in individuals with METS.
Read the detailed description
The main objective is to compare the effect of the administration of ACL/Leucine vs. Metformin on visceral fat area in patients with METS. We will conduct a double-blind trial, randomized, on 4 groups, each group with 26 male and female patients of 35-65 years of age with METS diagnosed by IDF criteria. Randomization will determine who will receive the intervention during 8 week trial, each group will be like:
Group (A) intervention with ACL/Leucine plus Metformin: 26 individuals will receive ACL/Leucine in a dosis of 2,475mg per 24 hrs (1,650mg or 2 capsules with the first meal and 825 mg or 1 capsule with the second meal) plus Metformin in a dose of 500 mg per day (with the first bite of the second meal) during 8 weeks.
Group (B) Metformin plus Placebo of ACL/Leucine: 26 individuals will receive Metformin in a dose of 500 mg per day (with the first bite of the second meal) plus homologue placebo of ACL/Leucine (linseed oil capsules) in a dosis of 3600 mg each 24 hrs (2 capsules of 2400 mg with the first meal and 1200 mg or 1 capsule with the second meal) during 8 weeks.
Group (C) ACL/Leucine plus Metformin's Placebo: 26 individuals will receive ACL/Leucine in a dose of 2,475mg per 24 hrs (1,650mg or 2 capsules with the first meal and 825 mg or 1 capsule with the second meal) plus homologate placebo of metformin (calcined magnesia) in a dose of 500 mg per day (with the first bite of the second meal) during 8 weeks.
Group (D) Placebo of ACL/Leucine plus Placebo of Metformin: homologate placebo of ACL/Leucine (linseed oil capsules) in a dose of 3600 mg each 24 hrs (2 capsules of 2400 mg with the first meal and 1200 mg or 1 capsule with the second meal) plus homologated placebo of metformin (calcined magnesia capsules) in a dosis of 500 mg per day (with the first bite of the second meal) during 8 weeks.
The clinical findings and laboratory test include a metabolic profile and biosafety, which will be baseline and at 8 weeks.
Visceral fat area, epicardial fat, body weight, body fat, body mass index (BMI) and blood pressure will be determined during the inicial and final visit, likewise, hemodynamics parameters of arterial stiffness like aortic pulse wave velocity (PWVao), central pulse pressure (PPao), aortic augmentation index (IAxao) and central systolic blood pressure (cSBP) by an oscillometric monitoring system via BPLab ®. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. It is considered with significance at p<0.05.
- Conditions
- Metabolic Syndrome
- Being tested
- Conjugated linoleic acid/Leucine, Metformin, Placebo of ACL/Leucine, Placebo of Metformin
- Keywords
- Conjugated Linoleic Acid, Leucine, visceral fat area, Epicardial Fat, Hemodinamic Parameters
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjugated linoleic acid/LeucineDietary supplement
Also called UKN
Conjugated linoleic acid/Leucine capsules, 825mg time daily with the first bite of eat meal during 12 weeks.
MetforminDrug
Also called Predial plus
Metformin in a dosis of 500mg per day (with the first bite of the second meal) during 12 weeks
Placebo of ACL/LeucineDietary supplement
Also called Linseed oil
Homologate placebo of ACL/Leucine (linseed oil capsules) in a dosis of 3600 mg each 24 hrs (2 capsules of 2400 mg with the first meal and 1200 mg or 1 capsule with the second meal) during 12 weeks.
Placebo of MetforminOther
Also called Calcinated magnesia
homologate placebo of metformin (calcinated magnesia) in a dosis of 500 mg per day (with the first bite of the second meal) during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| cojugated ALC/Leucine+Metformin | Experimental | Intervention with conjugated linoleic acid/Leucine + 500mg in individuals with METS Receives: Dietary Supplement: Conjugated linoleic acid/Leucine; Drug: Metformin |
| Metformin+placebo conjugatedALC/leucine | Active comparator | active comparator with Metformin 500mg + Placebo of ACL/Leucine in individuals with METS Receives: Drug: Metformin; Dietary Supplement: Placebo of ACL/Leucine |
| Placebo of Metformin | Placebo comparator | Active comparator with ACL/Leucine + Placebo of Metformin in individuals with METS Receives: Dietary Supplement: Conjugated linoleic acid/Leucine; Other: Placebo of Metformin |
| ACL/Leu placebo | Placebo comparator | Placebo comparator with ACL/Leu placebo + Metformin placebo in individuals with METS Receives: Dietary Supplement: Placebo of ACL/Leucine; Other: Placebo of Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in visceral fat area messure in centimers ^2 at 8 weeks
Before and after intervention using a visceral fat monitor Omron's dual impedance analysis method scan HDS-2000
Measured: baseline and 8 weeks
Secondary outcomes (4)
2. Change from Baseline epicardial fat area messure in milimeters ^2 at 8 weeks
Before and after intervention with ecocardiogragh imagic master of Kontron Medical.
Measured: baseline and 8 weeks
1. Change from Baseline in weight expressed in kg at 8 weeks
Before and after intervention using a tetrapolar bioelectrical impedance analyzer (body composition analyzer TBF-215 - Tanita)
Measured: baseline and 8 weeks
Change from baseline in Body Mass Index, expressed in kg/m^2 at 8 weeks
before and after intervention using a tetrapolar bioelectrical impedance analyzer (body composition analyzer TBF-215 - Tanita)
Measured: baseline and 8 weeks
Change from baseline in Total Tody Fat, expressed in percentage at 8 weeks
before and after intervention using a tetrapolar bioelectrical impedance analyzer (body composition analyzer TBF-215 - Tanita)
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Grover Paez, Centro Universitario de Ciencias de la Salud, Mexico
- Investigators
- Fernando Grover-Páez, PhD, Principal investigator, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629627
- Sponsor's protocol ID
- CUCS-INTEC-MV-UKN-001
- Status last verified
- Feb 2018
- First submitted
- 10 Dec 2015
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Administration of Conjugated Linoleic Acid / Leucine Plus Metformin on Visceral Fat in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02629627
- Acronym / sponsor ID
- CUCS-INTEC-MV-UKN-001
- Conditions
- Metabolic Syndrome
- Keywords
- Conjugated Linoleic Acid, Leucine, visceral fat area, Epicardial Fat, Hemodinamic Parameters
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 14 Dec 2015 (estimated)
- 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.
In Mexico, obesity is a major public health problem. In recent years he has presented a considerable increase in the population. As a result, it has triggered a proportional increase in the incidence of cardiovascular disease and the development of Metabolic Syndrome (METS). Abdominal obesity is one of the main components of METS which is generally associated with insulin resistance / hyperinsulinemia. This is influenced both by the subcutaneous adipose tissue as visceral adipose tissue. There is evidence that the visceral fat has an important bearing on many factors of METS, like: glucose intolerance, hypertension, dyslipidemia, and insulin resistance.
For management it requires a multidisciplinary approach, including changes in lifestyle, psychological and nutritional intervention as well as pharmacological and non-pharmacological support.
Among non-pharmacological therapies, there is recently the use of Conjugated Linoleic Acid (ACL) and leucine where in its assigned properties include weight reduction, anti-atherogenic , hypocholesterolemic and immunostimulant effect and anticarcinogenic properties. Regarding weight reduction dominates the mechanism of action anti-lipolytic effect. But, studies are needed to link this consumption with the increase or decrease on visceral fat in individuals with METS.
Detailed description
The main objective is to compare the effect of the administration of ACL/Leucine vs. Metformin on visceral fat area in patients with METS. We will conduct a double-blind trial, randomized, on 4 groups, each group with 26 male and female patients of 35-65 years of age with METS diagnosed by IDF criteria. Randomization will determine who will receive the intervention during 8 week trial, each group will be like:
Group (A) intervention with ACL/Leucine plus Metformin: 26 individuals will receive ACL/Leucine in a dosis of 2,475mg per 24 hrs (1,650mg or 2 capsules with the first meal and 825 mg or 1 capsule with the second meal) plus Metformin in a dose of 500 mg per day (with the first bite of the second meal) during 8 weeks.
Group (B) Metformin plus Placebo of ACL/Leucine: 26 individuals will receive Metformin in a dose of 500 mg per day (with the first bite of the second meal) plus homologue placebo of ACL/Leucine (linseed oil capsules) in a dosis of 3600 mg each 24 hrs (2 capsules of 2400 mg with the first meal and 1200 mg or 1 capsule with the second meal) during 8 weeks.
Group (C) ACL/Leucine plus Metformin's Placebo: 26 individuals will receive ACL/Leucine in a dose of 2,475mg per 24 hrs (1,650mg or 2 capsules with the first meal and 825 mg or 1 capsule with the second meal) plus homologate placebo of metformin (calcined magnesia) in a dose of 500 mg per day (with the first bite of the second meal) during 8 weeks.
Group (D) Placebo of ACL/Leucine plus Placebo of Metformin: homologate placebo of ACL/Leucine (linseed oil capsules) in a dose of 3600 mg each 24 hrs (2 capsules of 2400 mg with the first meal and 1200 mg or 1 capsule with the second meal) plus homologated placebo of metformin (calcined magnesia capsules) in a dosis of 500 mg per day (with the first bite of the second meal) during 8 weeks.
The clinical findings and laboratory test include a metabolic profile and biosafety, which will be baseline and at 8 weeks.
Visceral fat area, epicardial fat, body weight, body fat, body mass index (BMI) and blood pressure will be determined during the inicial and final visit, likewise, hemodynamics parameters of arterial stiffness like aortic pulse wave velocity (PWVao), central pulse pressure (PPao), aortic augmentation index (IAxao) and central systolic blood pressure (cSBP) by an oscillometric monitoring system via BPLab ®. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. It is considered with significance at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cojugated ALC/Leucine+Metformin | Experimental | Dietary Supplement: Conjugated linoleic acid/Leucine, Drug: MetforminIntervention with conjugated linoleic acid/Leucine + 500mg in individuals with METS |
| Metformin+placebo conjugatedALC/leucine | Active comparator | Drug: Metformin, Dietary Supplement: Placebo of ACL/Leucineactive comparator with Metformin 500mg + Placebo of ACL/Leucine in individuals with METS |
| Placebo of Metformin | Placebo comparator | Dietary Supplement: Conjugated linoleic acid/Leucine, Other: Placebo of MetforminActive comparator with ACL/Leucine + Placebo of Metformin in individuals with METS |
| ACL/Leu placebo | Placebo comparator | Dietary Supplement: Placebo of ACL/Leucine, Other: Placebo of MetforminPlacebo comparator with ACL/Leu placebo + Metformin placebo in individuals with METS |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of metabolic syndrome by IDF criteria:
- Raised triglycerides ≥ 150 mg/dL (1.7 mmol/L) or specific treatment for this lipid abnormality Reduced HDL colesterol
- < 40 mg/dL (1.03 mmol/L) in males < 50 mg/dL (1.29 mmol/L) in females or specifi c treatment for this lipid abnormality
- Raised blood pressure systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension
- Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes
Key exclusion criteria (8 listed)
- Ascitis
- With previous abdominal surgery
- Pathologies that course with abdominal wall edema fluid retention
- Paniculitis of reumatic origin or any other ethiology
- Reumatic pathologies
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 |
|---|---|---|
| Conjugated linoleic acid/LeucineAlso: UKNConjugated linoleic acid/Leucine capsules, 825mg time daily with the first bite of eat meal during 12 weeks. | Dietary supplement | Placebo of Metformin, cojugated ALC/Leucine+Metformin |
| MetforminAlso: Predial plusMetformin in a dosis of 500mg per day (with the first bite of the second meal) during 12 weeks | Drug | Metformin+placebo conjugatedALC/leucine, cojugated ALC/Leucine+Metformin |
| Placebo of ACL/LeucineAlso: Linseed oilHomologate placebo of ACL/Leucine (linseed oil capsules) in a dosis of 3600 mg each 24 hrs (2 capsules of 2400 mg with the first meal and 1200 mg or 1 capsule with the second meal) during 12 weeks. | Dietary supplement | ACL/Leu placebo, Metformin+placebo conjugatedALC/leucine |
| Placebo of MetforminAlso: Calcinated magnesiahomologate placebo of metformin (calcinated magnesia) in a dosis of 500 mg per day (with the first bite of the second meal) during 8 weeks | Other | ACL/Leu placebo, Placebo of Metformin |
Primary outcome
Change from Baseline in visceral fat area messure in centimers ^2 at 8 weeks
Time frame: baseline and 8 weeks
Before and after intervention using a visceral fat monitor Omron's dual impedance analysis method scan HDS-2000
4 secondary outcomes
2. Change from Baseline epicardial fat area messure in milimeters ^2 at 8 weeks
Time frame: baseline and 8 weeks
1. Change from Baseline in weight expressed in kg at 8 weeks
Time frame: baseline and 8 weeks
Change from baseline in Body Mass Index, expressed in kg/m^2 at 8 weeks
Time frame: baseline and 8 weeks
Change from baseline in Total Tody Fat, expressed in percentage at 8 weeks
Time frame: baseline and 8 weeks
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 5 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Fernando Grover-Páez, PhD principal investigator
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conjugated linoleic acid/Leucine and Metformin in people with Metabolic Syndrome, run by Centro Universitario de Ciencias de la Salud, Mexico.
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 9 inclusion and 8 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 visceral fat area messure in centimers ^2 at 8 weeks (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2018.