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

NCT05913986 | Unknown DMC

• 1 other identifier: SaluzInvestigacion
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Associated Fatty Liver Disease

Keywords

fatty liver disease

Outcome Measures

Primary Outcomes (1)

• Transitional elastography with Fibroscan

  30 minutes (performed after a 4-hour fast)

Secondary Outcomes (2)

• controlled attenuation parameter (CAP)

  30 minutes (performed after a 4-hour fast)

• kilopascals (kpa)

  30 minutes (performed after a 4-hour fast)

Study Arms (2)

Alpha-lipoic acid and y silybum marianum

EXPERIMENTAL

LUDLEV®300 mg/46.2 mg once day

Other: Placebo

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: LUDLEV®300 mg/46.2 mg

Interventions

LUDLEV®300 mg/46.2 mg DIETARY_SUPPLEMENT

LUDLEV®300 mg/46.2 mg once day

Placebo

Placebo OTHER

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

Alpha-lipoic acid and y silybum marianum

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saluz Investigación S. C.: lead

Study Sites (1)

Ana Delfina Cano Contreras

Mexico, Veracruz, 917000, Mexico

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

ANA D CONTRERAS, MD

CONTACT

2881011174; anacano_143@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Allocation is 1:1 to probiotic and placebo arms

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 22, 2023
• Study Start: March 1, 2023
• Primary Completion: January 10, 2024
• Study Completion: March 30, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

ME (1)