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Completed

NCT Number: NCT02366052

Nutritional Counseling vs. Nutritional Supplements for NASH - a Randomized Prospective, Open Label Pilot Study

The main aim of the study is to determine if an oral supplementation of the LCS has a beneficial effect by itself or even enhances the beneficial effects of a moderate life-style intervention on the progression of NAFLD in humans.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Fatty Liver, Nonalcoholic Liver Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut für Ernährungswissenschaften, University Jena, Jena, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elevated M30 antigen levels (cutoff: >200 - 800 U/L) at screening AND hepatic steatosis on ultrasound

OR histologically confirmed NASH

  • Age 18 to 75 years

Exclusion criteria

  • Alcohol intake of more than 30 g/d (men) or 20 g/d (women)
  • Treatment with ursodeoxycholic acid (UDCA), Vitamin E or other investigational NASH drugs 3 months prior to randomization
  • Treatment with medications or substances that may induce secondary NASH (e.g., tamoxifen, corticosteroids, amiodarone, methotrexate) or ameliorate NASH (TNF-antagonists)
  • Treatment with phenprocoumon or warfarin
  • Hepatocellular carcinoma or non-hepatic malignancy
  • Decompensated cirrhosis (Child B,C) or a history of decompensation
  • Liver disease unrelated to NASH, including chronic viral hepatitis B/D or C, autoimmune hepatitis, Wilson's disease or clinical manifest iron overload
  • Bariatric surgery within the last 5 years
  • BMI <18,5 kg/m2 or BMI >45 kg/m2
  • Liver transplantation
  • Heart failure (New York Heart Association Class II - IV)
  • Myocardial infarction, instable coronary artery disease , coronary artery intervention or stroke in the previous 6 months
  • Instable chronic obstructive pulmonary disease, chronic inflammatory bowel disease or rheumatoid arthritis.
  • Instable renal insufficiency (changes in serum creatinin > 50% in the last 3 month) or terminal renal insufficiency requiring dialysis
  • Uncontrolled hypertension (blood pressure > 180/90 despite therapy)
  • Uncontrolled diabetes mellitus defined by hemoglobin A1c > 9
  • Food allergies requiring strictly dietary adherence
  • Pregnant or nursing women
  • Chronic pancreatitis or history of recurring acute pancreatitis

Treatment and study plan

Nutritional counseling

Behavioral

Nutritional counseling by a trained nutritionist for 12 weeks.

Lactobacillus casei Shirota (LcS)

Dietary Supplement

The dietary supplement LCS (Yakult plus) will be given 2 times a day for 12 weeks in addition to dietary counseling every 3 weeks.

Other names: Yakult plus

Nutritional Counseling and LCS

Other

Nutritional counseling by a trained nutritionist in addition to the dietary supplement LCS (2 times a day) for 12 weeks.

Other names: Nutritional Counseling and Yakult plus

Primary outcomes

  1. Reduction of the M30 antigen in the serum

    Time frame: 12 and 24 weeks

    Reduction of the M30 antigen as a validated measure of the degree of hepatocellular inflammation and injury

Secondary outcomes

  1. Change in indicators of hepatocellular injury and fibrosis

    Time frame: 12 and 24 weeks

    Change in indicators of hepatocellular injury (ALT, gammaGT, M30/M60 antigen ratio, ELF score), proinflammatory cytokines (hsCRP, ferritin, plasminogen activator-1, endotoxin), surrogate parameters of liver fibrosis (fibrosis marker panels, Fibrotest, ELF score) and relative liver stiffness (assessed by Fibro Scan)

  2. Change in metabolic risk factors

    Time frame: 12 and 24 weeks

    Changes in metabolic risk factors (BMI, waist circumference, Homeostasis Model Assessment/Matsuda Score, serum lipids), changes in oral glucose tolerance and changes in hepatic steatosis will be assessed.

  3. Saftey and tolerability

    Time frame: 12 and 24 weeks

    Safety is assessed by (1) clinical examination, (2) clinical chemistries including serum electrolytes, renal, liver function tests and markers of pancreatic injury.

Other outcomes

  1. Improvement in measures of nutritional physiology

    Time frame: 12 and 24 weeks

    Improvement of nutritional physiology, compliance, self-perceived efficacy, emotional eating behavior using a validated questionnaires.

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Collaborators

  • University of Jena

Registry information

Official study title

Nutritional Counseling Versus Nutritional Supplements for the Treatment of NASH - a Randomized Prospective, Open Label Pilot Study (Nuces NASH)

Acronym: NucesNASH

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 19, 2015
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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