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 composition: study protocol for the AELC randomized controlled trial

BMC Public Health

Sulin Cheng²  Pei Jie Chen^1,11  Jia Xin Yao⁶  Ronald J H Borra⁹  Rui Li¹  Yi Min Zhang⁴  Xue Bo Chen⁸  Wen Bin Liu⁸  Jun Jun Liu⁵  Zheng Chang Xia⁵  Qing Gu⁷  Yan Qiu Chen^1,10  Petri Wiklund²  Eveliina Munukka²  Satu Pekkala²  Xiao Tan²  Shu Mei Cheng²  Yang Liu³  Xin Fei Wen^1,11  Jie Ren^1,11  Chang Xu^1,11  Jun Zou^1,11  Ru Wang^1,11  Ren Wei Wang^1,11  Jun Ge⁷  Jian Qin Sun^1,10  Xia Ming Du⁷  Da Jiang Lu^1,11  Wu Yi Liu^1,11 

[1] Department of Diabetes Control, Shanghai Municipal Center for Disease Control & Prevention, Shanghai, China;Department of Health Sciences, University of Jyväskylä, 40014 Jyväskylä, Finland;Research Centre for Health Promotion, Department of Health Sciences, University of Jyväskylä, 40014 Jyväskylä, Finland;Teaching Experiment Centre, Beijing Sport University, Beijing, China;Yanji Health Care Service Centre, Yangpu District, Shanghai, China;Department of Psychology, Tianjin University of Sport, Tianjin, China;Shanghai Shidong Hospital, Shanghai, China;Wujiaochang Health Care Service Centre, Yangpu District, Shanghai, China;Department of Diagnostic Radiology, University of Turku and Turku University Hospital, Turku, Finland;Clinical Nutrition Centre, Fudan University Huadong Hospital, Shanghai, China;School of Kinesiology, Shanghai University of Sport, 200438 Shanghai, China

关键词: Clinical setting;    Human;    Metabonomics;    Gut microbiota;    Lipid metabolism;    Glucose metabolism;    Liver fat content;   

Others  :  1161334
DOI  :  10.1186/1471-2458-14-48

 received in 2014-01-09, accepted in 2014-01-14,  发布年份 2014

【 摘 要 】

Background

Pre-diabetes and non-alcoholic fatty liver disease (NAFLD) are associated with an unhealthy lifestyle and pose extremely high costs to the healthcare system. In this study, we aim to explore whether individualized aerobic exercise (AEx) and low carbohydrate diet (LCh) intervention affect hepatic fat content (HFC) in pre-diabetes via modification of gut microbiota composition and other post-interventional effects.

Methods/design

A 6-month randomized intervention with 6-month follow-up is conducted from January 2013 to December 2015. The target sample size for intervention is 200 postmenopausal women and middle-aged men aged 50–65 year-old with pre-diabetes and NAFLD. The qualified subjects are randomized into 4 groups with 50 subjects in each group: 1 = AEx, 2 = LCh, 3 = AEx + LCh, and 4 = control. In addition, two age-matched reference groups (5 = pre-diabetes without NAFLD (n = 50) and 6 = Healthy without pre-diabetes or NAFLD (n = 50)) are included. The exercise program consists of progressive and variable aerobic exercise (intensity of 60 to 75% of initial fitness level, 3–5 times/week and 30–60 min/time). The diet program includes dietary consultation plus supplementation with a special lunch meal (40% of total energy intake/day) which aims to reduce the amount of carbohydrate consumption (30%). The control and reference groups are advised to maintain their habitual habits during the intervention. The primary outcome measures are HFC, serum metabolomics and gut microbiota composition. The secondary outcome measures include body composition and cytokines. In addition, socio-psychological aspects, social support, physical activity and diet will be performed by means of questionnaire and interview.

Discussion

Specific individualized exercise and diet intervention in this study offers a more efficient approach for liver fat reduction and diabetes prevention via modification of gut microbiota composition. Besides, the study explores the importance of incorporating fitness assessment and exercise in the management of patients with pre-diabetes and fatty liver disorders. If our program is shown to be effective, it will open new strategies to combat these chronic diseases.

Trial registration

Current Controlled Trials: ISRCTN42622771.

【 授权许可】

   
2014 Liu et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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