Non Alcoholic Fatty Liver Disease (NAFLD) Clinical Trial
Official title:
Impact of n-3 Fatty Acid Supplementation on the Metabolic Abnormalities in Children With NAFLD
Verified date | July 2014 |
Source | St. Justine's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Nonalcoholic hepatic steatosis (NASH) is defined as the amount greater than 5% of the total liver volume fat. Commonly known as NASH, it includes 4 stages histological ranging from the mere presence of fat to the existence of fibrosis and degeneration of hepatocytes, and finally a progression to cirrhosis, sometimes accompanied by complications of hepatocellular carcinoma. It is a common condition associated with a combination of disorders, namely obesity, insulin resistance and type 2 diabetes. The link with the metabolic syndrome (MetS) was mainly studied in the adult population and very little in the paediatric population, while 15 and 25% of obese children are affectés. The severity of histological disease appears to be associated with the degree of obesity in children and particularly in the MetS. in addition, epidemiological data indicate that the incidence of this disease is increasing in children and positioning as the first NASH liver disease in North America. the revelation of the factors associated with the occurrence of NASH is a first necessary step to understanding this disorder worrying for the future of children and adolescents. In addition, clarification of the mechanisms responsible for its development is essential if the investigators want to consider targeted and effective treatments to slow the rat race of NASH, which stands out as the supreme chronic liver accompanying the obesity and MetS. Finally, in view of growth and puberty of children, it would be extremely beneficial to find nutritional avenues that would avoid the side effects of chemical agents.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | December 2015 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 8 Years to 18 Years |
Eligibility |
Inclusion Criteria: - boys (according to the literature review on NAFLD prevalence) - body weight = 95th percentile (based on the CDC Chart) - aged <18 years - have a diffusely hyperechogenic liver at ultrasonography (consistent with NAFLD diagnostic) - have normal or high transaminases (> 2N). Exclusion Criteria: - Subjects with pin or cochlear implants - Subjects who consumed natural medicine products - Those in whom a surgical procedure was planned - the child who were found to consume fish, flaxseed oil and foods enriched with n-3 PUFA (eggs, or milk containing n-3 PUFA supplements), probiotics, vitamin E or use of drugs known to induce fatty liver during the study. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | CHU Ste-Justine | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
St. Justine's Hospital | Nutrisanté Canada |
Canada,
Bélanger SA, Vanasse M, Spahis S, Sylvestre MP, Lippé S, L'heureux F, Ghadirian P, Vanasse CM, Levy E. Omega-3 fatty acid treatment of children with attention-deficit hyperactivity disorder: A randomized, double-blind, placebo-controlled study. Paediatr Child Health. 2009 Feb;14(2):89-98. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Short term versus long-term treatment comparison | To compare the effectiveness of omega 3 PUFA between 12- and 24-weeks by a composite measures in terms of percent decrease in the transaminases (ALT/AST/GGT) body weight (BMI) Insulin resistance (HOMA-IR) Oxidative stress (malondialdehyde marker) Inflammation (TNF-alpha, interleukin-6, leptin and resistin) Lipids (triglycerides, cholesterol, LDL-cholesterol, HDL-cholesterol) changes in adipose tissue (DEXA) |
12 weeks vs. 24 weeks | Yes |
Primary | Efficacy of omega 3 PUFA supplementation in NAFLD subjects compared to placebos | Two groups from our cohort will be double blind supplemented either with n-3 PUFA or sun flower (as a placebo). The specific primary outcome is to assess the activities of hepatic plasma transaminase enzymes (ALT/AST/GGT) in the omega 3 group and to determine their decrease to the normal range. |
24 weeks | Yes |
Secondary | A composite mesures regarding the improvement of metabolic profile of NAFLD patients | To determine the decrease in obesity (body mass index) insulin resistance (HOMA-IR) Adipose tissue lowering (DEXA) Oxidative stress (Malondialdehyde biomarker, oxLDL) Inflammation (TNFalpha, IL-6, leptin and resistine) Plasma lipids (triglycerides, total cholesterol, LDL and HDL cholesterol) |
24 weeks | Yes |