Status:
COMPLETED
Metabolic Cofactor Supplementation in Obese Patients With Non-Alcoholic Fatty Liver Disease
Lead Sponsor:
ScandiBio Therapeutics AB
Collaborating Sponsors:
Koç University
Koç University Hospital
Conditions:
Non-alcoholic Fatty Liver Disease (NAFLD)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This short-term, randomized, placebo-controlled, investigator-initiated trial aims to establish metabolic improvements in NAFLD subjects by dietary supplementation with cofactors N-acetylcysteine, L-c...
Detailed Description
In this study, investigators aim to lower liver fat content in obese patients with NAFLD by increasing the hepatic levels of pivotal metabolic cofactors via simultaneous dietary supplementation of ser...
Eligibility Criteria
Inclusion
- Men and women (18-70 years old)
- Body mass index \>27kg/m2
- Triglyceride levels ≤354 mg/dl and LDL chol ≤175 mg/dl
- No history of medication use for hepatic steatosis
- Increased liver fat (\>5.5%)
Exclusion
- Inability or unwillingness to give written informed consent
- Systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \> 105 mm Hg
- Type 1 or type 2 diabetes
- Chronic liver disease other than NAFLD (i.e. chronic infection with hepatitis C virus \[HCV\] or hepatitis B virus \[HBV\], autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency).
- Previous gastric or small bowel surgery
- Active gastric ulcer
- Inflammatory bowel disease
- ALT or AST \>3× ULN (upper limit of normal)
- Detection of cirrhosis by transient elastography or other imaging modalities
- Diarrhea (defined as more than 2 stool per day) within 7 days before enrollment
- Chronic kidney disease with an estimated glomerular filtration rate \<60 ml/min/1.73m2
- Significant cardiovascular co-morbidity (i.e. heart failure, documented coronary artery disease, valvular heart disease)
- Patients with active bronchial asthma
- Patients with phenylketonuria (contraindicated for NAC)
- Patients with histamine intolerance
- Clinically significant TSH level outside the normal range (0.04-6 mU/L)
- Known allergy for substances used in the study
- Concomitant medication use:
- Lipid-lowering drugs within 3 months
- Oral antidiabetics given for insulin resistance of obesity (metformin, liraglutide etc.) within 3 months
- Thiazide diuretics with a dose \>25 mg/d
- Postmenopausal estrogen therapy
- Any medication acting on nuclear hormone receptors or inducing Cytochromes P450 (CYPs)
- Self-administration of dietary supplements such as any vitamins, omega-3 products, or plant stanol/sterol products within 1 month
- Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen
- Use of an antimicrobial agent in the 4 weeks preceding randomization
- Active smokers consuming \>10 cigarettes/day
- Alcohol consumption over 192 grams for men and 128 grams for women per week
- Patients considered as inappropriate for this study for any reason (patients unable to undergo MRI study, noncompliance etc.)
- Subjects with Patatin-like phospholipase domain-containing protein 3( PNPLA3) I148M (homozygous for I148M)
- Women who are pregnant, are planning pregnancy, or who are breast-feeding
- Women of childbearing potential not protected by effective birth control method
- Active participation in another clinical study
Key Trial Info
Start Date :
July 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04330326
Start Date
July 20 2019
End Date
May 6 2022
Last Update
February 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Koç University Hospital
Istanbul, Turkey (Türkiye), 34010