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This study is designed to observe the effect of 5:2 intermittent calorie restriction (fasting 2 days each week) on liver fat content in MASLD patients with abnormal blood glucose.
Intermittent caloric restriction (ICR) can effectively reduce weight and facilitate blood glucose control, but whether it can be applied for clinical treatment to metabolic dysfunction-associated steatotic liver disease (MASLD) patients remains unclear. We intend to carry out this study in MASLD patients with abnormal glucose metabolism. It is an open-labeled randomized trial designed to observe the effect of 5:2 intermittent calorie restriction (fasting 2 days each week) on liver fat content in MASLD patients with abnormal blood glucose. 60 patients will be randomly divided into ICR group and control group for 12 weeks of intervention. ICR group: during the 2-day fasting-mimicking period each week, the food based on plant ingredients will be served (4 pieces of nutrition bars / day, 1:2:1 for breakfast, lunch and dinner, 124.4kcal / piece, 497.2kcal / day in total). In the rest 5 days each week, subjects are allowed ad libitum to their usual food. Control group (continuous calorie restriction, CCR): under the guidance of nutritionist, subjects have to learn the method of food calories calculation. The daily calories intake for control group should be: 25 kcal / kg × [height (cm) - 100] kg. Daily food diary is required in both groups. During the experiment, all subjects should maintain their exercise routine. The use of drugs affecting blood glucose and fatty liver should be avoided. After 12 weeks of intervention, the changes of liver fat content were evaluated by magnetic resonance spectroscopy (MRS) and Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF). The effects of ICR on body weight, blood glucose and body fat will also be evaluated. Both groups will be followed up on their changes of weight 4 weeks after intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Calorie Restriction (ICR) | Experimental | Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement (ZhenBaiNian nutrition bar, Beijing Wanlaikang Nutrition and Health Food Science and Technology Research Institute Co., Ltd, China) to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet. |
|
| Control (Continuous calorie restriction, CCR) | Other | Participants in control group were instructed to consume the prescribed calories (25 kcal / kg × [height (cm) - 100] kg) every day by eating conventional food without time restriction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent calorie restriction (ICR) | Behavioral | Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet. Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat).They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Liver Fat Content in % | Change of liver fat content in %. | From baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Weight | Change of weight in kilograms. | From baseline to week 12 |
| Change of Blood Glucose: Fasting Blood Glucose | Change of fasting blood glucose in mg/dL. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Fat Mass | measured by bioimpedance analyzer, fat mass in kilograms. | From baseline to week 12 |
| Change of Lean Mass | measured by bioimpedance analyzer, skeletal muscle mass in kilograms. |
Inclusion Criteria
Age 18-70
Diagnosed as fatty liver by ultrasound or magnetic resonance imaging
BMI ≥ 24 kg/m2
abnormal glucose metabolism: (meeting at least one):
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Hua Bian | Shanghai Zhongshan Hospital | Principal Investigator |
| Xin Gao | Shanghai Zhongshan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26707365 | Background | Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22. | |
| 28642059 | Background | Fan JG, Kim SU, Wong VW. New trends on obesity and NAFLD in Asia. J Hepatol. 2017 Oct;67(4):862-873. doi: 10.1016/j.jhep.2017.06.003. Epub 2017 Jun 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intermittent Calorie Restriction (ICR) | Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet. Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided. |
| FG001 | Control (Continuous Calorie Restriction, CCR) | Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × [height (cm) - 100] kg) every day by eating conventional food without time restriction. Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intermittent Calorie Restriction (ICR) | Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet. Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Liver Fat Content in % | Change of liver fat content in %. | Posted | Least Squares Mean | 95% Confidence Interval | absolute fat content change in % | From baseline to week 12 |
|
From 1 to 12 weeks.
No participant was at risk for Serious Adverse Events. No participant was at risk for All-Cause Mortality.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intermittent Calorie Restriction (ICR) | Intermittent calorie restriction (ICR): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet. Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue/Weakness | General disorders | Non-systematic Assessment | Fatigue/Weakness, mild, in fasting mimicking days of ICR group. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hua Bian | Zhongshan Hospital, Fudan University | +86 64041990 | zhongshan_bh@126.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2021 | Dec 3, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2021 | Dec 3, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
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Patients were randomly divided into intermittent calorie restriction group and control group for 12 weeks of intervention. Both groups will be followed up 4 weeks after intervention.
ICR group: during the 2-day fasting-mimicking period each week, the food based on plant ingredients will be served (4 pieces of nutrition bars / day, 1:2:1 for breakfast, lunch and dinner, 124.4kcal/piece, 497.2kcal / day in total). In the rest 5 days each week, subjects are allowed ad libitum to their usual food.
Control group: continuous calorie restriction (CCR). Under the guidance of nutritionist, subjects have to learn the method of food calories calculation. For each day, the daily calories intake is limited to 25 kcal / kg × standard weight [kg, estimated by height (cm) - 100].
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|
|
| Continuous calorie restriction (CCR) | Behavioral | Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × [height (cm) - 100] kg) every day by eating conventional food without time restriction. Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat).They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided. |
|
|
| From baseline to week 12 |
| Change of Blood Glucose: 2h Postload Blood Glucose | Change of 2h postload blood glucose in mg/dL. | From baseline to week 12 |
| Change of HbA1c | Change of HbA1c in %. | From baseline to week 12 |
| Change of Liver Enzymes: Alanine Aminotransferase | Change of alanine aminotransferase in U/L. | From baseline to week 12 |
| Change of Liver Enzymes: Aspartate Aminotransferase | Change of aspartate aminotransferase in U/L. | From baseline to week 12 |
| Change of Liver Enzymes: γ-glutamyl Transpeptidase | Change of γ-glutamyl transpeptidase in U/L. | From baseline to week 12 |
| Change of Lipid Profile: Total Cholesterol | Change of total cholesterol in mg/dL. | From baseline to week 12 |
| Change of Lipid Profile: Triglyceride | Change of triglyceride in mg/dL. | From baseline to week 12 |
| Change of Lipid Profile: High-density Lipoprotein-cholesterol | Change of high-density lipoprotein-cholesterol in mg/dL. | From baseline to week 12 |
| Change of Lipid Profile: Low-density Lipoprotein-cholesterol | Change of low-density lipoprotein-cholesterol in mg/dL. | From baseline to week 12 |
| Change of Lipid Profile: Free Fatty Acid | Change of free fatty acid in mg/dL. | From baseline to week 12 |
| From baseline to week 12 |
| Change of Abdominal Adipose Tissue Area | measured by MRI, including visceral adipose and subcutaneous adipose, all in square centimeter. | From baseline to week 12 |
| Change of Liver Stiffness Measure of Liver Transient Elastography | Change of liver stiffness measure of liver transient elastography, in kPa. | From baseline to week 12 |
| Change of Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index | Change of HOMA-IR index from baseline to week 12. HOMA-IR index was calculated as fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l)/22.5. A HOMA-IR index higher than 75th quartile of non diabetes subjects is considered to be insulin resistance. However, due to differences in race, gender and research subjects, there is currently no recognized cut-off point. The cut-off values of HOMA-IR reported in previous studies varied greatly. A study on Caucasian non diabetes population showed that the cut-off value is 2.29. And a Chinese study proposed that the cut-off value of population over 40 years old in Shanghai was 4.31 for men and 4.51 for women. | From baseline to week 12 |
| Change of Fasting Insulin | Change of fasting insulin in μU/mL. | From baseline to week 12 |
| 23855290 | Background | Fan JG. Epidemiology of alcoholic and nonalcoholic fatty liver disease in China. J Gastroenterol Hepatol. 2013 Aug;28 Suppl 1:11-7. doi: 10.1111/jgh.12036. |
| 25164003 | Background | Wang FS, Fan JG, Zhang Z, Gao B, Wang HY. The global burden of liver disease: the major impact of China. Hepatology. 2014 Dec;60(6):2099-108. doi: 10.1002/hep.27406. Epub 2014 Oct 29. |
| 11961152 | Background | Angulo P. Nonalcoholic fatty liver disease. N Engl J Med. 2002 Apr 18;346(16):1221-31. doi: 10.1056/NEJMra011775. No abstract available. |
| 26667191 | Background | Ballestri S, Zona S, Targher G, Romagnoli D, Baldelli E, Nascimbeni F, Roverato A, Guaraldi G, Lonardo A. Nonalcoholic fatty liver disease is associated with an almost twofold increased risk of incident type 2 diabetes and metabolic syndrome. Evidence from a systematic review and meta-analysis. J Gastroenterol Hepatol. 2016 May;31(5):936-44. doi: 10.1111/jgh.13264. |
| 12031978 | Background | Vozarova B, Stefan N, Lindsay RS, Saremi A, Pratley RE, Bogardus C, Tataranni PA. High alanine aminotransferase is associated with decreased hepatic insulin sensitivity and predicts the development of type 2 diabetes. Diabetes. 2002 Jun;51(6):1889-95. doi: 10.2337/diabetes.51.6.1889. |
| 24002776 | Background | Armstrong MJ, Adams LA, Canbay A, Syn WK. Extrahepatic complications of nonalcoholic fatty liver disease. Hepatology. 2014 Mar;59(3):1174-97. doi: 10.1002/hep.26717. Epub 2014 Jan 16. |
| 25050550 | Background | Musso G, Gambino R, Tabibian JH, Ekstedt M, Kechagias S, Hamaguchi M, Hultcrantz R, Hagstrom H, Yoon SK, Charatcharoenwitthaya P, George J, Barrera F, Hafliethadottir S, Bjornsson ES, Armstrong MJ, Hopkins LJ, Gao X, Francque S, Verrijken A, Yilmaz Y, Lindor KD, Charlton M, Haring R, Lerch MM, Rettig R, Volzke H, Ryu S, Li G, Wong LL, Machado M, Cortez-Pinto H, Yasui K, Cassader M. Association of non-alcoholic fatty liver disease with chronic kidney disease: a systematic review and meta-analysis. PLoS Med. 2014 Jul 22;11(7):e1001680. doi: 10.1371/journal.pmed.1001680. eCollection 2014 Jul. |
| 15842581 | Background | Huang MA, Greenson JK, Chao C, Anderson L, Peterman D, Jacobson J, Emick D, Lok AS, Conjeevaram HS. One-year intense nutritional counseling results in histological improvement in patients with non-alcoholic steatohepatitis: a pilot study. Am J Gastroenterol. 2005 May;100(5):1072-81. doi: 10.1111/j.1572-0241.2005.41334.x. |
| 30475966 | Background | Sundfor TM, Svendsen M, Tonstad S. Intermittent calorie restriction-a more effective approach to weight loss? Am J Clin Nutr. 2018 Nov 1;108(5):909-910. doi: 10.1093/ajcn/nqy288. No abstract available. |
| 28202779 | Background | Wei M, Brandhorst S, Shelehchi M, Mirzaei H, Cheng CW, Budniak J, Groshen S, Mack WJ, Guen E, Di Biase S, Cohen P, Morgan TE, Dorff T, Hong K, Michalsen A, Laviano A, Longo VD. Fasting-mimicking diet and markers/risk factors for aging, diabetes, cancer, and cardiovascular disease. Sci Transl Med. 2017 Feb 15;9(377):eaai8700. doi: 10.1126/scitranslmed.aai8700. |
| 28235195 | Background | Cheng CW, Villani V, Buono R, Wei M, Kumar S, Yilmaz OH, Cohen P, Sneddon JB, Perin L, Longo VD. Fasting-Mimicking Diet Promotes Ngn3-Driven beta-Cell Regeneration to Reverse Diabetes. Cell. 2017 Feb 23;168(5):775-788.e12. doi: 10.1016/j.cell.2017.01.040. |
| 31375753 | Background | Johari MI, Yusoff K, Haron J, Nadarajan C, Ibrahim KN, Wong MS, Hafidz MIA, Chua BE, Hamid N, Arifin WN, Ma ZF, Lee YY. A Randomised Controlled Trial on the Effectiveness and Adherence of Modified Alternate-day Calorie Restriction in Improving Activity of Non-Alcoholic Fatty Liver Disease. Sci Rep. 2019 Aug 2;9(1):11232. doi: 10.1038/s41598-019-47763-8. |
| 30475957 | Background | Schubel R, Nattenmuller J, Sookthai D, Nonnenmacher T, Graf ME, Riedl L, Schlett CL, von Stackelberg O, Johnson T, Nabers D, Kirsten R, Kratz M, Kauczor HU, Ulrich CM, Kaaks R, Kuhn T. Effects of intermittent and continuous calorie restriction on body weight and metabolism over 50 wk: a randomized controlled trial. Am J Clin Nutr. 2018 Nov 1;108(5):933-945. doi: 10.1093/ajcn/nqy196. |
| 17425870 | Background | Liu M, Yan HM, Gao X, Gao J. [Association of abnormality of liver enzymes and metabolic syndrome in patients with nonalcoholic fatty liver disease]. Zhonghua Yi Xue Za Zhi. 2007 Jan 23;87(4):253-5. Chinese. |
| 39447676 | Derived | Sun X, Li F, Yan H, Chang X, Yao X, Yang X, Wu S, Suo Y, Zhu X, Wang C, Gao J, Wang H, Chen Y, Xia M, Bian H, Gao X. Intermittent compared with continuous calorie restriction for treatment of metabolic dysfunction-associated steatotic liver disease: a randomized clinical trial. Am J Clin Nutr. 2025 Jan;121(1):158-166. doi: 10.1016/j.ajcnut.2024.10.012. Epub 2024 Oct 22. |
| BG001 | Control (Continuous Calorie Restriction, CCR) | Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × [height (cm) - 100] kg) every day by eating conventional food without time restriction. Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Duration of MASLD | Mean | Standard Deviation | years |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Waist circumference | Mean | Standard Deviation | cm |
|
| Visceral adipose area | Mean | Standard Deviation | cm2 |
|
| Subcutaneous adipose area | Mean | Standard Deviation | cm2 |
|
| Lean mass | Mean | Standard Deviation | kg |
|
| Fat mass | Mean | Standard Deviation | kg |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Fasting plasma glucose | Mean | Standard Deviation | mg/dL |
|
| 2h postprandial plasma glucose | Mean | Standard Deviation | mg/dL |
|
| HbA1c | Mean | Standard Deviation | % |
|
| Fasting insulin | Mean | Standard Deviation | μU/mL |
|
| Homeostasis model assessment of insulin resistance (HOMA-IR) index | HOMA-IR index was calculated as fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l)/22.5. A HOMA-IR index higher than 75th quartile of non diabetes subjects is considered to be insulin resistance. However, due to differences in race, gender and research subjects, there is currently no recognized cut-off point. A study on Caucasian non diabetes population showed that the cut-off value is 2.29. And a Chinese study proposed that the cut-off value of population over 40 years old in Shanghai was 4.31 for men and 4.51 for women. | Mean | Standard Deviation | index |
|
| Total cholesterol | Mean | Standard Deviation | mg/dL |
|
| Triglycerides | Mean | Standard Deviation | mg/dL |
|
| HDL cholesterol | Mean | Standard Deviation | mg/dL |
|
| LDL cholesterol | Mean | Standard Deviation | mg/dL |
|
| Free fatty acids | Mean | Standard Deviation | mg/dL |
|
| Alanine aminotransferase | Mean | Standard Deviation | U/L |
|
| Aspartate aminotransferase | Mean | Standard Deviation | U/L |
|
| γ-Glutamyl transpeptidase | Mean | Standard Deviation | U/L |
|
| Liver fat content by 1H-MRS | Mean | Standard Deviation | % |
|
| Liver fat content by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) | MRI-PDFF is a viable method for the quantification of whole liver and segmental liver fat content. The Couinaud classification is the most widely used system to describe functional liver anatomy.
| Mean | Standard Deviation | % |
|
| Controlled attenuation parameter | Controlled attenuation parameter (CAP) was measured by liver elastography, FibroScan. | Mean | Standard Deviation | dB/m |
|
| Liver stiffness | Liver stiffness was measured by liver elastography, FibroScan. | Mean | Standard Deviation | kPa |
|
| Comorbidities | Count of Participants | Participants |
|
| Concomitant drug use | Count of Participants | Participants |
|
| OG001 | Control (Continuous Calorie Restriction, CCR) | Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × [height (cm) - 100] kg) every day by eating conventional food without time restriction. Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided. |
|
|
| Secondary | Change of Weight | Change of weight in kilograms. | Posted | Least Squares Mean | 95% Confidence Interval | kg | From baseline to week 12 |
|
|
|
| Secondary | Change of Blood Glucose: Fasting Blood Glucose | Change of fasting blood glucose in mg/dL. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | From baseline to week 12 |
|
|
|
| Secondary | Change of Blood Glucose: 2h Postload Blood Glucose | Change of 2h postload blood glucose in mg/dL. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | From baseline to week 12 |
|
|
|
| Secondary | Change of HbA1c | Change of HbA1c in %. | Posted | Least Squares Mean | 95% Confidence Interval | HbA1c in % | From baseline to week 12 |
|
|
|
| Secondary | Change of Liver Enzymes: Alanine Aminotransferase | Change of alanine aminotransferase in U/L. | Posted | Least Squares Mean | 95% Confidence Interval | U/L | From baseline to week 12 |
|
|
|
| Secondary | Change of Liver Enzymes: Aspartate Aminotransferase | Change of aspartate aminotransferase in U/L. | Posted | Least Squares Mean | 95% Confidence Interval | U/L | From baseline to week 12 |
|
|
|
| Secondary | Change of Liver Enzymes: γ-glutamyl Transpeptidase | Change of γ-glutamyl transpeptidase in U/L. | Posted | Least Squares Mean | 95% Confidence Interval | U/L | From baseline to week 12 |
|
|
|
| Secondary | Change of Lipid Profile: Total Cholesterol | Change of total cholesterol in mg/dL. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | From baseline to week 12 |
|
|
|
| Secondary | Change of Lipid Profile: Triglyceride | Change of triglyceride in mg/dL. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | From baseline to week 12 |
|
|
|
| Secondary | Change of Lipid Profile: High-density Lipoprotein-cholesterol | Change of high-density lipoprotein-cholesterol in mg/dL. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | From baseline to week 12 |
|
|
|
| Secondary | Change of Lipid Profile: Low-density Lipoprotein-cholesterol | Change of low-density lipoprotein-cholesterol in mg/dL. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | From baseline to week 12 |
|
|
|
| Secondary | Change of Lipid Profile: Free Fatty Acid | Change of free fatty acid in mg/dL. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | From baseline to week 12 |
|
|
|
| Other Pre-specified | Change of Fat Mass | measured by bioimpedance analyzer, fat mass in kilograms. | Posted | Least Squares Mean | 95% Confidence Interval | kg | From baseline to week 12 |
|
|
|
| Other Pre-specified | Change of Lean Mass | measured by bioimpedance analyzer, skeletal muscle mass in kilograms. | Posted | Least Squares Mean | 95% Confidence Interval | kg | From baseline to week 12 |
|
|
|
| Other Pre-specified | Change of Abdominal Adipose Tissue Area | measured by MRI, including visceral adipose and subcutaneous adipose, all in square centimeter. | Posted | Least Squares Mean | 95% Confidence Interval | square centimeter | From baseline to week 12 |
|
|
|
| Other Pre-specified | Change of Liver Stiffness Measure of Liver Transient Elastography | Change of liver stiffness measure of liver transient elastography, in kPa. | Posted | Least Squares Mean | 95% Confidence Interval | kPa | From baseline to week 12 |
|
|
|
| Other Pre-specified | Change of Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index | Change of HOMA-IR index from baseline to week 12. HOMA-IR index was calculated as fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l)/22.5. A HOMA-IR index higher than 75th quartile of non diabetes subjects is considered to be insulin resistance. However, due to differences in race, gender and research subjects, there is currently no recognized cut-off point. The cut-off values of HOMA-IR reported in previous studies varied greatly. A study on Caucasian non diabetes population showed that the cut-off value is 2.29. And a Chinese study proposed that the cut-off value of population over 40 years old in Shanghai was 4.31 for men and 4.51 for women. | Posted | Least Squares Mean | 95% Confidence Interval | index | From baseline to week 12 |
|
|
|
| Other Pre-specified | Change of Fasting Insulin | Change of fasting insulin in μU/mL. | Posted | Least Squares Mean | 95% Confidence Interval | μU/mL | From baseline to week 12 |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 8 |
| 30 |
| EG001 | Control (Continuous Calorie Restriction, CCR) | Continuous calorie restriction (CCR): Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × [height (cm) - 100] kg) every day by eating conventional food without time restriction. Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat). They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided. | 0 | 30 | 0 | 30 | 0 | 30 |
|
| Dysphoria | General disorders | Non-systematic Assessment | Dysphoria, mild, in fasting mimicking days of ICR group. |
|
Not provided
Not provided
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |