Supplementation With Alpha-lipoic Acid and Silybum Marian... | NCT05913986

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

NCT05913986

Sponsor

Saluz Investigación S. C.

Status

Unknown status

Last Update Posted

Jun 22, 2023Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Metabolic Associated Fatty Liver Disease

Interventions

LUDLEV®300 mg/46.2 mg
Placebo

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Jan 10, 2024Estimated

Completion Date

Mar 30, 2024Estimated

First Submitted Date

Jun 4, 2023

First Submission Date that Met QC Criteria

Jun 12, 2023

First Posted Date

Jun 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2023

Last Update Posted Date

Jun 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
LUDLEV®300 mg/46.2 mg	Dietary Supplement	LUDLEV®300 mg/46.2 mg once day	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Transitional elastography with Fibroscan		30 minutes (performed after a 4-hour fast)

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 8, 2023	Jun 12, 2023	Prot_000.pdf
ICF	No	No	Yes	Informed Consent Form	Feb 8, 2023	Jun 4, 2023	ICF_001.pdf

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases