Diseases of liver Nutritional, Metabolic, Endocrine Oral and Gastrointestinal, Diseases of liver, Metabolic and Endocrine, Metabolic disorders
Conditions
Interventions
The main intervention consists of drinking a small bottle of beetroot juice twice a day. The beetroot juice contains a high or low concentration of nitrates: neither the participant nor the research t
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria (as of 07/02/2018): 1. Men with clinical diagnosis of non-alcoholic steatohepatitis and a mild (F0-F2) fibrosis stage as predicted by a FIB-4 score 5.5 mmol/L 5. Triglycerides = 1.7 mmol/L
Exclusion criteria
Exclusion criteria: 1. Current participation in other interventional clinical trials (to avoid confounding with other study outcomes), observational studies are allowed 2. Other hepatic diseases: i.e alcoholic (> 21U/wk), viral and autoimmune hepatitis (AIH, PSC, PBC), genetic conditions (e.g. hemochromatosis), drug-induced hepatitis, etc. 3. History of chronic conditions that could influence the study outcomes such as 3.1. Anaemia (Hb< 11g/dL) or abnormal values in WBC, platelet count, or INR 3.2. Glomerular filtration rate lower than 60 mL/min/1.73m2 or diuretics 3.3. Active cancer and any diagnosis of malignant cancer in the last 5 years 3.4. Chronic Inflammatory disease (e.g. IBD, rheumatoid arthritis) in chronic treatment with NSAIDs/Corticosteroids 3.5. Type 1 diabetes 4. Treatments that could influence the study outcomes such as: 4.1. Anti-Diabetic medications (Metformin, TZDs, insulin) 4.2. Lipid-lowering agents (Fibrates/Omega3) 4.3. Nitrate-derived agents 4.4. Anti-acids 4.5. Beta-blockers 4.6. Weight loss medications (sibutramine, orlistat, rimonabant) and history of bariatric surgery (weight loss related changes in systemic metabolism) 4.7. Hormonal therapies (oestrogens, thyroxine, and progesterone) 4.8. Anti-psychiatric drugs (antidepressants, sedatives, antipsychotics) 4.9. Sildenafil 4.10. Anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary outcome will be assessed through the changes measured at baseline, 7, 35, 42 and 70 days and include: 1.1. Plasma 3-aminoisobutyric acid which will be measured using liquid chromatography-mass spectrometry (LC-MS), 1.2. Changes in gene expression and activity of the key metabolic transcription factors peroxisome-proliferator activated receptor 1 alpha and delta in peripheral blood mononuclear cells using reverse-transcription and quantitative polymerase chain reaction | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The effect of nitrate supplementation on body composition measured using a bioelectrical impedance device at baseline, 7, 35, 42 and 70 days 2. The effect of nitrate supplementation on plasma lipidome using LC-MS at baseline, 7, 35, 42 and 70 days 3. The effect of nitrate supplementation on plasma and urine nitrate and polyphenols levels using mass spectrometry methods at baseline, 7, 35, 42 and 70 days | — |
Countries
England, United Kingdom
Outcome results
None listed