Serine Supplementation for Obese Subjects With Fatty Liver Disease

NCT02599038 | Completed Phase 1

• 1 other identifier: Serine-NAFLD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

In this study, the investigators aim to increase the liver tissue level of GSH in NAFLD patients by short-term dietary serine supplementation and improve their liver function by lowering the oxidative stress resulting from hepatic steatosis.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

NAFLD; NASH; Serine; Glutathione

Outcome Measures

Primary Outcomes (1)

• Liver fat content

  Liver fat measured by magnetic resonance spectroscopy

  2 weeks

Secondary Outcomes (2)

• Triglycerides

  2 weeks

• Cholesterol fractions

  2 weeks

Study Arms (1)

Serine supplementation

EXPERIMENTAL

Serine oral administration 20mg/kg/day

Dietary Supplement: Serine supplementation

Interventions

Serine supplementation DIETARY_SUPPLEMENT

Serine supplementation (200 mg/kg/day)

Serine supplementation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 30 - 39.9 kg/m2; stable weight (+/- 2 kg) within the last six months
• Sex Males, pre-, and post-menopausal females
• Women of childbearing potential can only be included if a safe and reliable contraception is used, e.g., oral contraceptives
• Diagnosis NAFLD established by both liver CT and ultrasound
• Consent Patients should have given their written consent to participate in this study

You may not qualify if:

• Chronic liver disease other than NAFLD (viral hepatitis, autoimmune liver disease, hemochromatosis, homozygous alpha1-antitrypsin deficiency and Wilson disease)
• Previous gastric or small bowel surgery
• Inflammatory bowel disease
• Uncontrolled diabetes mellitus (fasting blood glucose \>6.7 mmol/L), hypothyroidism or hyperthyroidism, or other significant endocrine disease. (A subject who is euthyroid on a stable replacement dose of thyroid hormone is acceptable provided the TSH is within normal range).
• Pregnancy. A urine pregnancy test will be performed the day before start of medication. Women of childbearing potential can only be included if a safe and reliable contraception is used, e.g., oral contraceptives.
• Elevations of transaminases (ALAT/ASAT) or alkaline phosphatase or bilirubin above 2xULN (upper limit of normal) the day before start of serine supplementation.
• Other serious disease, including depressive disorders treated by medication
• Patients who will not comply with the protocol.

Sponsors & Collaborators

• Hanns-Ulrich Marschall: lead

Study Sites (2)

Hanns-Ulrich Marschall

Gothenburg, 411 31, Sweden

Location

Sahlgrenska Academy

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Hanns-Ulrich Marschall, MD, PhD

  Sahlgrenska Academy and University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Hepatology

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 6, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)