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

Sponsor

Saluz Investigación S. C. (Other)

Overall Status

Recruiting

CT.gov ID

NCT05913986

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Associated Fatty Liver Disease	Dietary Supplement: LUDLEV®300 mg/46.2 mg Other: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Allocation is 1:1 to probiotic and placebo armsAllocation is 1:1 to probiotic and placebo arms

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jan 10, 2024

Anticipated Study Completion Date :

Mar 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alpha-lipoic acid and y silybum marianum LUDLEV®300 mg/46.2 mg once day	Other: Placebo Placebo treatment (maltodextrin), once daily (u.i.d)
Placebo Comparator: Placebo Placebo treatment (maltodextrin), once daily (u.i.d)	Dietary Supplement: LUDLEV®300 mg/46.2 mg LUDLEV®300 mg/46.2 mg once day

Arm

Intervention/Treatment

Experimental: Alpha-lipoic acid and y silybum marianum

LUDLEV®300 mg/46.2 mg once day

Other: Placebo

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

Placebo Comparator: Placebo

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

Dietary Supplement: LUDLEV®300 mg/46.2 mg

LUDLEV®300 mg/46.2 mg once day

Outcome Measures

Primary Outcome Measures

Transitional elastography with Fibroscan [30 minutes (performed after a 4-hour fast)]

Secondary Outcome Measures

controlled attenuation parameter (CAP) [30 minutes (performed after a 4-hour fast)]
Hepatic steatosis by controlled attenuation parameter
kilopascals (kpa) [30 minutes (performed after a 4-hour fast)]
Hepatic stiffness by Transitional elastography with Fibroscan

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ana Delfina Cano Contreras	Mexico	Veracruz	Mexico	917000

Sponsors and Collaborators

Saluz Investigación S. C.

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Saluz Investigación S. C.

ClinicalTrials.gov Identifier:

NCT05913986

Other Study ID Numbers:

SaluzInvestigacion

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Saluz Investigación S. C.

fatty liver disease

Additional relevant MeSH terms:

Liver Diseases

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Jun 22, 2023