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Conjugated Linoleic Acid / Leucine Versus Metformin on Visceral Fat in Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Conjugated linoleic acid/Leucine
Metformin
Placebo of ACL/Leucine
Placebo of Metformin
Sponsored by
Centro Universitario de Ciencias de la Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Conjugated Linoleic Acid, Leucine, visceral fat area, Epicardial Fat, Hemodinamic Parameters

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Placebo Comparator

    Arm Label

    cojugated ALC/Leucine+Metformin

    Metformin+placebo conjugatedALC/leucine

    Placebo of Metformin

    ACL/Leu placebo

    Arm Description

    Intervention with conjugated linoleic acid/Leucine + 500mg in individuals with METS

    active comparator with Metformin 500mg + Placebo of ACL/Leucine in individuals with METS

    Active comparator with ACL/Leucine + Placebo of Metformin in individuals with METS

    Placebo comparator with ACL/Leu placebo + Metformin placebo in individuals with METS

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    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)
    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)
    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)

    Full Information

    First Posted
    December 10, 2015
    Last Updated
    February 1, 2018
    Sponsor
    Centro Universitario de Ciencias de la Salud, Mexico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02629627
    Brief Title
    Conjugated Linoleic Acid / Leucine Versus Metformin on Visceral Fat in Metabolic Syndrome
    Official Title
    Effect of the Administration of Conjugated Linoleic Acid / Leucine Plus Metformin on Visceral Fat in Patients With Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    October 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centro Universitario de Ciencias de la Salud, Mexico

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome
    Keywords
    Conjugated Linoleic Acid, Leucine, visceral fat area, Epicardial Fat, Hemodinamic Parameters

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    104 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    cojugated ALC/Leucine+Metformin
    Arm Type
    Experimental
    Arm Description
    Intervention with conjugated linoleic acid/Leucine + 500mg in individuals with METS
    Arm Title
    Metformin+placebo conjugatedALC/leucine
    Arm Type
    Active Comparator
    Arm Description
    active comparator with Metformin 500mg + Placebo of ACL/Leucine in individuals with METS
    Arm Title
    Placebo of Metformin
    Arm Type
    Placebo Comparator
    Arm Description
    Active comparator with ACL/Leucine + Placebo of Metformin in individuals with METS
    Arm Title
    ACL/Leu placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo comparator with ACL/Leu placebo + Metformin placebo in individuals with METS
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Conjugated linoleic acid/Leucine
    Other Intervention Name(s)
    UKN
    Intervention Description
    Conjugated linoleic acid/Leucine capsules, 825mg time daily with the first bite of eat meal during 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Other Intervention Name(s)
    Predial plus
    Intervention Description
    Metformin in a dosis of 500mg per day (with the first bite of the second meal) during 12 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo of ACL/Leucine
    Other Intervention Name(s)
    Linseed oil
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo of Metformin
    Other Intervention Name(s)
    Calcinated magnesia
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change from Baseline in visceral fat area messure in centimers ^2 at 8 weeks
    Description
    Before and after intervention using a visceral fat monitor Omron's dual impedance analysis method scan HDS-2000
    Time Frame
    baseline and 8 weeks
    Secondary Outcome Measure Information:
    Title
    2. Change from Baseline epicardial fat area messure in milimeters ^2 at 8 weeks
    Description
    Before and after intervention with ecocardiogragh imagic master of Kontron Medical.
    Time Frame
    baseline and 8 weeks
    Title
    1. Change from Baseline in weight expressed in kg at 8 weeks
    Description
    Before and after intervention using a tetrapolar bioelectrical impedance analyzer (body composition analyzer TBF-215 - Tanita)
    Time Frame
    baseline and 8 weeks
    Title
    Change from baseline in Body Mass Index, expressed in kg/m^2 at 8 weeks
    Description
    before and after intervention using a tetrapolar bioelectrical impedance analyzer (body composition analyzer TBF-215 - Tanita)
    Time Frame
    baseline and 8 weeks
    Title
    Change from baseline in Total Tody Fat, expressed in percentage at 8 weeks
    Description
    before and after intervention using a tetrapolar bioelectrical impedance analyzer (body composition analyzer TBF-215 - Tanita)
    Time Frame
    baseline and 8 weeks
    Other Pre-specified Outcome Measures:
    Title
    Change from Baseline in central systolic blood pressure in mm/Hg at 8 weeks
    Description
    Before and after intervention with oscillometric monitoring system via BPLab
    Time Frame
    baseline and 8 weeks
    Title
    Change from Baseline in Pulse Wave Velocity in meters/ second at 8 weeks
    Description
    Before and after intervention with oscillometric monitoring system via BPLab
    Time Frame
    baseline and 8 weeks
    Title
    Change from Baseline in Fasting plasma glucose in mg/dL at 8 weeks
    Description
    Before and after intervention by spectrophotometry
    Time Frame
    baseline and 8 weeks
    Title
    Change from Baseline in Total cholesterol in mg/dL at 8 weeks
    Description
    Before and after intervention by spectrophotometry
    Time Frame
    baseline and 8 weeks
    Title
    Change from Baseline in Triglycerids in mg/dL at 8 weeks
    Description
    Before and after intervention by spectrophotometry
    Time Frame
    baseline and 8 weeks
    Title
    Change from Baseline in High-density lipoprotein colesterol in mg/dL at 8 weeks
    Description
    Before and after intervention by friedewall formula
    Time Frame
    baseline and 8 weeks
    Title
    Change from Baseline in Low-density lipoprotein colesterol in mg/dL at 8 weeks
    Description
    Before and after intervention by friedewall formula
    Time Frame
    baseline and 8 weeks
    Title
    Change from Baseline in Alanine aminotransferase in IU/L at 8 weeks
    Description
    Before and after intervention by spectrophotometry
    Time Frame
    baseline and 8 weeks
    Title
    Change from Baseline in Aspartate aminotransferase in UI/L at 8 weeks
    Description
    Before and after intervention by spectrophotometry
    Time Frame
    baseline and 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fernando Grover-Páez, PhD
    Organizational Affiliation
    Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Conjugated Linoleic Acid / Leucine Versus Metformin on Visceral Fat in Metabolic Syndrome

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