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

NCT02629627 | Completed Phase 2

• 1 other identifier: CUCS-INTEC-MV-UKN-001
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome

Keywords

Conjugated Linoleic Acid; Leucine; visceral fat area; Epicardial Fat; Hemodinamic Parameters

Outcome Measures

Primary Outcomes (1)

• 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

  baseline and 8 weeks

Secondary Outcomes (4)

• 2. Change from Baseline epicardial fat area messure in milimeters ^2 at 8 weeks

  baseline and 8 weeks

• 1. Change from Baseline in weight expressed in kg at 8 weeks

  baseline and 8 weeks

• Change from baseline in Body Mass Index, expressed in kg/m^2 at 8 weeks

  baseline and 8 weeks

• Change from baseline in Total Tody Fat, expressed in percentage at 8 weeks

  baseline and 8 weeks

Other Outcomes (9)

• Change from Baseline in central systolic blood pressure in mm/Hg at 8 weeks

  baseline and 8 weeks

• Change from Baseline in Pulse Wave Velocity in meters/ second at 8 weeks

  baseline and 8 weeks

• Change from Baseline in Fasting plasma glucose in mg/dL at 8 weeks

  baseline and 8 weeks

Study Arms (4)

cojugated ALC/Leucine+Metformin

EXPERIMENTAL

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

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

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

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

Dietary Supplement: Placebo of ACL/Leucine; Other: Placebo of Metformin

Interventions

Conjugated linoleic acid/Leucine DIETARY_SUPPLEMENT

Conjugated linoleic acid/Leucine capsules, 825mg time daily with the first bite of eat meal during 12 weeks.

Also known as: UKN

Placebo of Metformin; cojugated ALC/Leucine+Metformin

Metformin DRUG

Metformin in a dosis of 500mg per day (with the first bite of the second meal) during 12 weeks

Also known as: Predial plus

Metformin+placebo conjugatedALC/leucine; cojugated ALC/Leucine+Metformin

Placebo of ACL/Leucine DIETARY_SUPPLEMENT

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.

Also known as: Linseed oil

ACL/Leu placebo; Metformin+placebo conjugatedALC/leucine

Placebo of Metformin OTHER

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

Also known as: Calcinated magnesia

ACL/Leu placebo; Placebo of Metformin

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Universitario de Ciencias de la Salud, Mexico: lead

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Metformin; Linseed Oil

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Fernando Grover-Páez, PhD

  Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fernando Grover-Paez, PhD

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share