Purified Anthocyanin and Nonalcoholic Fatty Liver Disease

NCT01940263 | Completed Early Phase 1 DMC

• 2 other identifiers: SGU-0281372994
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Oxidative stress and inflammation are involved in the pathogenesis of non-alcoholic fatty liver disease (NAFLD). Anthocyanins from different plant foods have been shown to improve features of experimental NASH, such as oxidative stress, dyslipidemia, liver steatosis, and inflammation in rodents. The purpose of this study is to investigate whether purified anthocyanin supplementation beneficially alters oxidative, inflammatory, and apoptotic biomarkers in adults with features of NAFLD.

Conditions

Nonalcoholic Fatty Liver Disease

Keywords

oxidative stress; dyslipidemia; inflammation; apoptosis

Outcome Measures

Primary Outcomes (1)

• Biomarkers related to oxidative stress

  plasma total antioxidant capacity; plasma levels of protein carbonyl groups

  Twelve weeks

Secondary Outcomes (1)

• Biomarkers related to inflammation

  Twelve weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo 320 mg daily for twelve weeks

Dietary Supplement: Placebo

Anthocyanin

EXPERIMENTAL

Drug: MEDOX (natural purified anthocyanin) anthocyanin 320 mg daily for twelve weeks.

Dietary Supplement: Anthocyanin

Interventions

Anthocyanin DIETARY_SUPPLEMENT

Also known as: MEDOX (natural purified anthocyanin), http://www.medox.no/english

Anthocyanin

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \[body weight divided by height squared (in kg/m2)\] \> 23,
• lack of excessive alcohol ingestion confirmed by careful questioning by the primary physician and dietitians (consumption of less than 70 g alcohol in female and 140 g in male per week), and
• the presence of two of the three following diagnostic criteria of the fatty liver disease: increased hepatic echogenicity compared to the spleen or the kidneys, blurring of liver vasculature and deep attenuation of the ultrasonographic signal.

You may not qualify if:

• overuse of alcohol,
• viral hepatitis,
• type 1 or 2 diabetes,
• gastrointestinal or connective diseases,
• chronic pancreatitis,
• liver cirrhosis,
• kidney stones, or renal failure;
• use of acetyl-salicylic acid or other antiplatelet drugs, statins of fibrates, oral hypoglycemic drugs, nitrates, nonsteroidal antiinflammatory drugs, corticosteroids, or drugs interfering with coagulation;
• supplementation with vitamins or antioxidants

Sponsors & Collaborators

• Shaoguan University: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Shaoguan University

Shaoguan, Guangdong, 512005, China

Location

Related Publications (2)

• Zhang PW, Chen FX, Li D, Ling WH, Guo HH. A CONSORT-compliant, randomized, double-blind, placebo-controlled pilot trial of purified anthocyanin in patients with nonalcoholic fatty liver disease. Medicine (Baltimore). 2015 May;94(20):e758. doi: 10.1097/MD.0000000000000758.

  PMID: 25997043 DERIVED

• Liu Y, Chen H, Wang J, Zhou W, Sun R, Xia M. Association of serum retinoic acid with hepatic steatosis and liver injury in nonalcoholic fatty liver disease. Am J Clin Nutr. 2015 Jul;102(1):130-7. doi: 10.3945/ajcn.114.105155. Epub 2015 May 6.

  PMID: 25948673 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Dyslipidemias; Inflammation

Interventions

Anthocyanins

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates; Pigments, Biological; Biological Factors

Study Officials

• Wenhua Ling, Ph.D

  Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: September 12, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 1, 2014

Record last verified: 2014-07

Locations

CN (1)