Effect of aerobic exercise and low carbohydrate diet on pre-diabetic non-alcoholic fatty liver disease in postmenopausal women and middle aged men -? the role of gut microbiota compositio

Not Applicable

Completed

• Conditions: on-alcoholic fatty liver disease; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN42622771
• Lead Sponsor: Shanghai University of Sport (China)

Brief Summary

2014 Protocol article in https://pubmed.ncbi.nlm.nih.gov/24438438/ protocol (added 23/10/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35538056/ results of impact on gut microbiota (added 11/05/2022) 2017 Results article in https://pubmed.ncbi.nlm.nih.gov/29162875/ results of impact on hepatic fat content (HFC) and glycaemic control (added 11/05/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-23
• Study Completion: 2015-12-31
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 115

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 (<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)
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

Previous inclusion criteria:
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), and triglycerides > 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

1. BMI >38 kg/m2
2. Serious cardiovascular or musculoskeletal problems
3. Diagnosed Type 1 and 2 diabetes
4. Mental distraction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 02/02/2017:<br> 1. Liver fat content %, measured using single-voxel proton magnetic resonance spectroscopy (1H MRS) at baseline and 6 months<br> 2. Glycaemic control, measured using the glucose tolerance test at baseline and 6 months<br> 3. Gut microbiota composition, measured using 16s rRNA gene sequencing by Illumina MiSeq platform and metagenomics sequencing at baseline, 3 months and 6 months<br><br> Previous primary outcome measures:<br> 1. Glucose tolerance test results, insulin and triglycerides, assessed at baseline and 6 months<br> 2. Liver fat content %, assessed at baseline and 6 months<br> 3. Gut microbiota composition, measured at baseline, 3 months and 6 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Lifestyle, behavioral characteristics, diet, physical activity and health condition, measured using questionnaires<br> 2. Anthropometry (height, body weight)<br> 3. Blood pressure<br> 4. Body composition (fat mass, lean mass and bone mass)<br> 5. Physical fitness and heart rate, measured using the UKK walk test<br> 6. Muscle strength (maximal isometric voluntary contraction of the right grip, left elbow flexors and left knee extensors)<br> 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<br><br> 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)<br>