Metabolic Associated Fatty Liver DiseaseNCT05913986
Supplementation With Alpha-lipoic Acid and Silybum Marianum(LUDLEV®) for the Improvement of Fatty Liver Disease
A study testing LUDLEV®300 mg/46.2 mg in people with Metabolic Associated Fatty Liver Disease, run by Saluz Investigación S. C. at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Associated Fatty Liver Disease
- What is being tested?
- LUDLEV®300 mg/46.2 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Ana Delfina Cano Contreras
Mexico, Veracruz, 917000
ANA DELFINA CANO CONTRERAS, MD, 2299318011, anacano_143@hotmail.com
About this study
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
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.
Read the 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.
- Conditions
- Metabolic Associated Fatty Liver Disease
- Being tested
- LUDLEV®300 mg/46.2 mg, Placebo
- Keywords
- fatty liver disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUDLEV®300 mg/46.2 mgDietary supplement
LUDLEV®300 mg/46.2 mg once day
PlaceboOther
Placebo treatment (maltodextrin), once daily (u.i.d)
| Study group | Role | What they receive |
|---|---|---|
| Alpha-lipoic acid and y silybum marianum | Experimental | LUDLEV®300 mg/46.2 mg once day Receives: Other: Placebo |
| Placebo | Placebo comparator | Placebo treatment (maltodextrin), once daily (u.i.d) Receives: Dietary Supplement: LUDLEV®300 mg/46.2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transitional elastography with Fibroscan
Measured: 30 minutes (performed after a 4-hour fast)
Secondary outcomes (2)
controlled attenuation parameter (CAP)
Hepatic steatosis by controlled attenuation parameter
Measured: 30 minutes (performed after a 4-hour fast)
kilopascals (kpa)
Hepatic stiffness by Transitional elastography with Fibroscan
Measured: 30 minutes (performed after a 4-hour fast)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Mar 2023
- Primary completion10 Jan 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Associated Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation is 1:1 to probiotic and placebo arms
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saluz Investigación S. C.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913986
- Sponsor's protocol ID
- SaluzInvestigacion
- Status last verified
- Jun 2023
- First submitted
- 4 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05913986
- Acronym / sponsor ID
- SaluzInvestigacion
- Conditions
- Metabolic Associated Fatty Liver Disease
- Keywords
- fatty liver disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Saluz Investigación S. C.University, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 10 Jan 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Allocation is 1:1 to probiotic and placebo arms
| Arm | Type | Receives |
|---|---|---|
| Alpha-lipoic acid and y silybum marianum | Experimental | Other: PlaceboLUDLEV®300 mg/46.2 mg once day |
| Placebo | Placebo comparator | Dietary Supplement: LUDLEV®300 mg/46.2 mgPlacebo treatment (maltodextrin), once daily (u.i.d) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUDLEV®300 mg/46.2 mgLUDLEV®300 mg/46.2 mg once day | Dietary supplement | Placebo |
| PlaceboPlacebo treatment (maltodextrin), once daily (u.i.d) | Other | Alpha-lipoic acid and y silybum marianum |
Primary outcome
Transitional elastography with Fibroscan
Time frame: 30 minutes (performed after a 4-hour fast)
2 secondary outcomes
controlled attenuation parameter (CAP)
Time frame: 30 minutes (performed after a 4-hour fast)
kilopascals (kpa)
Time frame: 30 minutes (performed after a 4-hour fast)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUDLEV®300 mg/46.2 mg in people with Metabolic Associated Fatty Liver Disease, run by Saluz Investigación S. C. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANA D CONTRERAS, MD (2881011174, anacano_143@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transitional elastography with Fibroscan (time frame: 30 minutes (performed after a 4-hour fast)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.