The Effect of Curcumin on Liver Fat Content in Obese Subjects

Summary

The majority of obese have non-alcoholic fatty liver disease (NALFD). Currently, no pharmacological agents are licenced for the prevention or treatment of NAFLD, and weight loss, notoriously difficult to obtain (and specially to maintain), remains the only treatment option. Interestingly, curcumin, a phenolic compound extracted from the turmeric root, has from in vitro and animal studies shown promising effects in preventing and treating NAFLD, and the sparse available human data point in the same direction; but solid human data are missing. This study will delineate the effects of curcumin when treating NAFLD in humans.

The primary aim of this study is to investigate the effect of 6 weeks of curcumin on liver fat content (assessed by magnetic resonance spectroscopy (MRS)) in obese subject with NAFLD. Additionally, a range of secondary endpoints have been chosen in order to delineate the role of NAFLD in the newly discovered liver-alpha cell axis governing circulating levels of the glucose-mobilising pancreatic alpha cell hormone glucagon and, thus, to elucidate the link between liver fat content and the risk of developing reduced glucose tolerance and type 2 diabetes (T2D). Also, the anti-inflammatory effect of curcumin will be elucidated, as inflammatory markers will be measured before and after intervention. Furthermore, the effect of curcumin will be measured by measuring the following parameters before and after intervention: Transient elastography, anthropometric measurements, body weight, appetite, food-consumption, calory balance, resting energy expenditure, gut microbiota, bioimpedance measures, visceral- and subcutaneous fat, glucose tolerance, lipids, blood pressure, pulse, liver parameters (blood-tests) and adipokines. During the oral glucose tolerance test before and after intervention, incretin hormones, glucagon, amino acids, insulin, c-peptide and urea will be measured.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Insulin Resistance
• Glucose Tolerance Impaired
• Obesity, Abdominal

Interventions

DIETARY_SUPPLEMENT

Curcumin (Meriva®)

Experimental drug: Meriva® 500 mg tablet (contains 1 mg curcumin)

DRUG

Placebo Oral Tablet

Placebo: Contains same ingredients as Meriva®, apart from curcumin. Similar in appearance to Meriva®.

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• University of Aarhus

  collaborator OTHER

• Herlev and Gentofte Hospital

  collaborator OTHER

• Steno Diabetes Center Copenhagen

  lead OTHER

Principal Investigators

• Pernille H Hellmann, MD · Center for Clinical Metabolic Research, Gentofte Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-05

Primary Completion

2020-12-16

Completion

2020-12-16

Countries

• Denmark

Study Locations