Metabolic Cofactor Supplementation in Obese Patients With Non-Alcoholic Fatty Liver Disease

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-carnitine tartrate, nicotinamide riboside and serine. Concomitant use of pivotal metabolic cofactors via simultaneous dietary supplementation will stimulate three different pathways to enhance hepatic β-oxidation and this study's hypothesis is that this will result in decreased amount of fat in the liver.

Conditions

• Non-alcoholic Fatty Liver Disease (NAFLD)

Interventions

DRUG

Metabolic Cofactor Supplementation

Subjects in active treatment will receive dietary supplementation with N-acetylcysteine, L-carnitine tartrate, nicotinamide riboside, and serine, administered as a mixture. Half dosage of the co-factors will be given for two weeks (one dose taken just after dinner), and full dosage for 8 weeks (two equal doses taken just after breakfast and dinner).

DRUG

Sorbitol

As placebo, sorbitol (5 g) flavored with strawberry aroma and coloring agent will be given. Sorbitol is widely used due to its solubility in water. It's approved by the U.S. Food and Drug Administration (FDA).

Sponsors & Collaborators

• Koç University

  collaborator OTHER

• Koç University Hospital

  collaborator UNKNOWN

• Göteborg University

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• KTH Royal Institute of Technology

  collaborator OTHER

• University of Helsinki

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Monitor CRO

  collaborator INDUSTRY

• ScandiBio Therapeutics AB

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-20

Primary Completion

2020-07-29

Completion

2022-05-06

Countries

• Turkey (Türkiye)

Study Locations