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Supplementation With Alpha-lipoic Acid and Silybum Marianum(LUDLEV®) for the Improvement of Fatty Liver Disease

Primary Purpose

Metabolic Associated Fatty Liver Disease

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
LUDLEV®300 mg/46.2 mg
Placebo
Sponsored by
Saluz Investigación S. C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Associated Fatty Liver Disease focused on measuring fatty liver disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects treated at the Instituto de Investigaciones Médico Biológicas de la Universidad Veracruzana with a diagnosis of Fatty Liver Disease Agree to voluntarily participate in the study and sign informed consent. Patients with evidence of hepatic steatosis who are overweight or obese Patients with evidence of hepatic steatosis with diabetes mellitus and overweight or obesity. Patients with evidence of steatosis plus metabolic risk abnormalities will be included (waist circumference >102 in men, 88 cm in women, blood pressure >130/85 mmHg or specific treatment, triglycerides >150 mg/dL or specific treatment, HDL cholesterol < 40 mg/dL in men, <50 mg/dL in women or specific treatment, HOMA-IR >2.5, CRP >2 mg/L or prediabetes defined by fasting glucose detection 100 to 125 mg/dL, postload glucose 2 hours 140 to 199 mg/dL or HbA1c between 5.7 to 6.4%) Accept not to start any diet program during the study period. Agree not to change your current exercise plan during the study period Exclusion Criteria: Patients meeting diagnostic criteria for Fatty Liver Disease with normal weight Patients with terminal illness, cancer, renal disease in renal replacement therapy Pregnant women Patients with inability to understand or follow the study protocol Sensitivity to the components of the formula.

Sites / Locations

  • Ana Delfina Cano ContrerasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alpha-lipoic acid and y silybum marianum

Placebo

Arm Description

LUDLEV®300 mg/46.2 mg once day

Placebo treatment (maltodextrin), once daily (u.i.d)

Outcomes

Primary Outcome Measures

Transitional elastography with Fibroscan

Secondary Outcome Measures

controlled attenuation parameter (CAP)
Hepatic steatosis by controlled attenuation parameter
kilopascals (kpa)
Hepatic stiffness by Transitional elastography with Fibroscan

Full Information

First Posted
June 4, 2023
Last Updated
June 12, 2023
Sponsor
Saluz Investigación S. C.
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1. Study Identification

Unique Protocol Identification Number
NCT05913986
Brief Title
Supplementation With Alpha-lipoic Acid and Silybum Marianum(LUDLEV®) for the Improvement of Fatty Liver Disease
Official Title
Effect of Supplementation With Alpha-lipoic Acid and Silybum Marianum (LUDLEV®) in Association With a Mediterranean Diet for the Improvement of Metabolic Dysfunction-associated Fatty Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
January 10, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saluz Investigación S. C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized, controlled, double-blind study evaluates the utility of alpha-lipoic acid and silybum marianum , versus placebo, in the treatment of metabolic associated fatty liver disease.
Detailed Description
Between 80-90% of people with associated metabolic fatty liver disease present with obesity and diabetes mellitus. Alpha-lipoic acid is a cofactor of mitochondrial enzymes that has been considered an antioxidant since its reduced form, dihydrolipoate, reacts with reactive oxygen species and thus protects the cell membrane. Alpha-lipoic acid administration has been shown to have beneficial effects on adipokine levels and metabolic disorders such as diabetes and obesity, both of which are present in patients with MAFLD. It has been shown that the administration of 1200 mg of alpha-lipoic acid in patients with fatty liver decreases insulin resistance, serum leptin, increases the concentration of adiponectin. Given the metabolic effects of alpha-lipoic acid, it is hypothesized that administration of this formulation may be beneficial for people with metabolic associated fatty liver disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Associated Fatty Liver Disease
Keywords
fatty liver disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Allocation is 1:1 to probiotic and placebo arms
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alpha-lipoic acid and y silybum marianum
Arm Type
Experimental
Arm Description
LUDLEV®300 mg/46.2 mg once day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo treatment (maltodextrin), once daily (u.i.d)
Intervention Type
Dietary Supplement
Intervention Name(s)
LUDLEV®300 mg/46.2 mg
Intervention Description
LUDLEV®300 mg/46.2 mg once day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo treatment (maltodextrin), once daily (u.i.d)
Primary Outcome Measure Information:
Title
Transitional elastography with Fibroscan
Time Frame
30 minutes (performed after a 4-hour fast)
Secondary Outcome Measure Information:
Title
controlled attenuation parameter (CAP)
Description
Hepatic steatosis by controlled attenuation parameter
Time Frame
30 minutes (performed after a 4-hour fast)
Title
kilopascals (kpa)
Description
Hepatic stiffness by Transitional elastography with Fibroscan
Time Frame
30 minutes (performed after a 4-hour fast)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects treated at the Instituto de Investigaciones Médico Biológicas de la Universidad Veracruzana with a diagnosis of Fatty Liver Disease Agree to voluntarily participate in the study and sign informed consent. Patients with evidence of hepatic steatosis who are overweight or obese Patients with evidence of hepatic steatosis with diabetes mellitus and overweight or obesity. Patients with evidence of steatosis plus metabolic risk abnormalities will be included (waist circumference >102 in men, 88 cm in women, blood pressure >130/85 mmHg or specific treatment, triglycerides >150 mg/dL or specific treatment, HDL cholesterol < 40 mg/dL in men, <50 mg/dL in women or specific treatment, HOMA-IR >2.5, CRP >2 mg/L or prediabetes defined by fasting glucose detection 100 to 125 mg/dL, postload glucose 2 hours 140 to 199 mg/dL or HbA1c between 5.7 to 6.4%) Accept not to start any diet program during the study period. Agree not to change your current exercise plan during the study period Exclusion Criteria: Patients meeting diagnostic criteria for Fatty Liver Disease with normal weight Patients with terminal illness, cancer, renal disease in renal replacement therapy Pregnant women Patients with inability to understand or follow the study protocol Sensitivity to the components of the formula.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ANA D CONTRERAS, MD
Phone
2881011174
Email
anacano_143@hotmail.com
Facility Information:
Facility Name
Ana Delfina Cano Contreras
City
Mexico
State/Province
Veracruz
ZIP/Postal Code
917000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANA DELFINA CANO CONTRERAS, MD
Phone
2299318011
Email
anacano_143@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Supplementation With Alpha-lipoic Acid and Silybum Marianum(LUDLEV®) for the Improvement of Fatty Liver Disease

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