Non-alcoholic fatty liver disease Nutritional, Metabolic, Endocrine
Conditions
Interventions
6-month exercise or/and diet intervention is involved in this study.
There are six study arms but four randomized arms:
1. Exercise
2. Diet
exercise information is updated monthly.
Diet intervention:
Specific individualized dietary program is developed after baseline assessments on the basis of each indivi
Sponsors
Shanghai University of Sport (China)
Shanghai Jiao Tong University (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 02/02/2017: 1. Men or women aged 50-65 with fasting glucose between 5.6 to 6.9 mmol/ or glucose between 7.8 to 11.0 mmol/L after 2 hour in takes of glucose (75 g) 2. Have diagnosed non-alcoholic fatty liver disease (NAFLD) by 1H MRS (liver fat >5%) 3. For women, serum follicle-stimulating hormone level greater than 30 IU/L and last menstruation more than 6 months ago but within 10 years Reference group 1: 1. Men or women aged 50-65 with fasting glucose between 5.6 to 6.9 mmol/L or glucose between 7.8 to 11.0 mmol/L after 2 hour in takes of glucose (75 g) 2. No NAFLD by MRS ( 1.7 mmol/L. 2. Have diagnosed non-alcoholic fatty liver disease (NAFLD) by 1H MRS (liver fat >5%). 3. For women, serum follicle-stimulating hormone level greater than 30 IU/L and last menstruation more than 6 months ago but within 10 years. Reference group 1: 1. Men or women aged 50-65 with fasting glucose between 5.6 to 6.9 mmol/L or glucose between 7.8 to 11.0 mmol/L after 2 hour in takes of glucose (75 g), and triglycerides > 1.7 mmol/L 2. No NAFLD by MRS (<5%) 3. For women serum follicle-stimulating hormone level greater than 30 IU/L and last menstruation more than 6 months ago but within 10 years Reference group 2: 1. Men or women aged 50-65 with fasting glucose below 5.6 mmol/L or glucose below 7.8 mmol/L after 2 hour in takes of glucose (75 g), and triglycerides < 1.7 mmol/L 2. No NAFLD by MRS (<5%) 3. For women serum follicle-stimulating hormone level greater than 30 IU/L and last menstruation more than 6 months ago but within 10 years
Exclusion criteria
Exclusion criteria: 1. BMI >38 kg/m2 2. Serious cardiovascular or musculoskeletal problems 3. Diagnosed Type 1 and 2 diabetes 4. Mental distraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 02/02/2017: 1. Liver fat content %, measured using single-voxel proton magnetic resonance spectroscopy (1H MRS) at baseline and 6 months 2. Glycaemic control, measured using the glucose tolerance test at baseline and 6 months 3. Gut microbiota composition, measured using 16s rRNA gene sequencing by Illumina MiSeq platform and metagenomics sequencing at baseline, 3 months and 6 months Previous primary outcome measures: 1. Glucose tolerance test results, insulin and triglycerides, assessed at baseline and 6 months 2. Liver fat content %, assessed at baseline and 6 months 3. Gut microbiota composition, measured at baseline, 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lifestyle, behavioral characteristics, diet, physical activity and health condition, measured using questionnaires 2. Anthropometry (height, body weight) 3. Blood pressure 4. Body composition (fat mass, lean mass and bone mass) 5. Physical fitness and heart rate, measured using the UKK walk test 6. Muscle strength (maximal isometric voluntary contraction of the right grip, left elbow flexors and left knee extensors) 7. Total cholesterol, HDL-cholesterol, triglycerides, LDL-cholesterol, apolipoproteins A-I and B, lipoprotein (a), cholesterylester fatty acid composition, free fatty acid profile and sex hormones, AND inflammation biomarkers, measured from a venous blood sample All measured at baseline, 3 months and 6 months (except for body composition [fat mass, lean mass and bone mass], which is measured at baseline and 6 months only) | — |
Countries
China, Finland
Outcome results
None listed