Intervention on Metabolism and Related Chronic Diseases

Metabolic Syndrome Clinical Trial

Official title:

Effects of Intensive Lifestyle Interventions (ILI) on Weight Loss and Cardiometabolic Risks in Obese Adults With Metabolic Syndrome: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06271200
• Other study ID #: MG-113-GP-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: National Health Research Institutes, Taiwan
• Contact: Vivian Wang, Master
• Phone: +886-37-206166
• Email: ywwang[@]nhri.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1. The ILI group will be instructed to eat in 8 hours while fasting in 16 hours on daily basis over 24 weeks. Furthermore, enhanced daily physical activities with walking more than 10,000 steps will be implemented. The enrolled participants will be instructed to follow a diet with reduction of daily intake of 500 kcals per day. ILI group will be asked to use the Health2Sync mobile app to track self-measured outcomes and daily diet control. The investigators objectively measure step counts for participants of ILI group during 24-week intervention period using a wearable device (Fitbit Inspire 2). Participants are asked to attach the pedometer on their waist belt, except while bathing and sleeping. The ULI group will be instructed to follow habitual meal timing. In addition, all participants of both groups will receive the health education. Anthropometric, sociodemographic data, biochemical variables, and metabolic variables will be measured at baseline and during follow-up visit. DEXA and MRI of abdomen will be measured at baseline and during following up visits. The proposed trial is designed to provide 85% statistical power to detect a significant difference in changes in the metabolic syndrome severity score after reduction > 5% body weight over 24 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2027
• Est. primary completion date: January 19, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Men or women aged from = 20 years to 65 years
• BMI 27.0 to 45.0 kg/m2 with metabolic syndrome by IDF definition

Exclusion Criteria:

• History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis
• Diagnosis of type 1 or type 2 diabetes and regular taking oral or injection hypoglycemic therapy
• History of malignant tumors with active managements.
• Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2)
• History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months History of severe gastrointestinal diseases or gastrointestinal surgery in the past 6 months
• History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity without regular managements.
• Taking medications affecting weight or energy intake/energy expenditure in the last 3 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician
• Currently participating in weight loss programs or weight change in the past 3 months (>5% current body weight)
• Women who are pregnant or plan to become pregnant
• Patients who cannot be followed for 3 years (due to a health situation or migration)
• Patients who are unwilling or unable to give informed consent

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Other:
• Intermittent fasting and 10,000 steps per day
Reduce calories intake and eat as "168" pattern, namely, eating foods for 8 hours while fast for 16 hours at daily basis plus walking more than 10,000 steps per day.

Locations

Country	Name	City	State
Taiwan	Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes	Zhunan	Miaoli County

Sponsors (5)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Chang Gung Memorial Hospital, National Taiwan University Hospital Hsin-Chu Branch, Taichung Armed Forces General Hospital, Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (24)

Chaix A, Manoogian ENC, Melkani GC, Panda S. Time-Restricted Eating to Prevent and Manage Chronic Metabolic Diseases. Annu Rev Nutr. 2019 Aug 21;39:291-315. doi: 10.1146/annurev-nutr-082018-124320. Epub 2019 Jun 10. — View Citation

Chow LS, Manoogian ENC, Alvear A, Fleischer JG, Thor H, Dietsche K, Wang Q, Hodges JS, Esch N, Malaeb S, Harindhanavudhi T, Nair KS, Panda S, Mashek DG. Time-Restricted Eating Effects on Body Composition and Metabolic Measures in Humans who are Overweight: A Feasibility Study. Obesity (Silver Spring). 2020 May;28(5):860-869. doi: 10.1002/oby.22756. Epub 2020 Apr 9. — View Citation

Das SK, Balasubramanian P, Weerasekara YK. Nutrition modulation of human aging: The calorie restriction paradigm. Mol Cell Endocrinol. 2017 Nov 5;455:148-157. doi: 10.1016/j.mce.2017.04.011. Epub 2017 Apr 12. — View Citation

de Cabo R, Mattson MP. Effects of Intermittent Fasting on Health, Aging, and Disease. N Engl J Med. 2019 Dec 26;381(26):2541-2551. doi: 10.1056/NEJMra1905136. No abstract available. Erratum In: N Engl J Med. 2020 Jan 16;382(3):298. N Engl J Med. 2020 Mar 5;382(10):978. — View Citation

Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488. — View Citation

Gami AS, Witt BJ, Howard DE, Erwin PJ, Gami LA, Somers VK, Montori VM. Metabolic syndrome and risk of incident cardiovascular events and death: a systematic review and meta-analysis of longitudinal studies. J Am Coll Cardiol. 2007 Jan 30;49(4):403-14. doi: 10.1016/j.jacc.2006.09.032. Epub 2007 Jan 12. — View Citation

Gill S, Panda S. A Smartphone App Reveals Erratic Diurnal Eating Patterns in Humans that Can Be Modulated for Health Benefits. Cell Metab. 2015 Nov 3;22(5):789-98. doi: 10.1016/j.cmet.2015.09.005. Epub 2015 Sep 24. — View Citation

Gurka MJ, Lilly CL, Oliver MN, DeBoer MD. An examination of sex and racial/ethnic differences in the metabolic syndrome among adults: a confirmatory factor analysis and a resulting continuous severity score. Metabolism. 2014 Feb;63(2):218-25. doi: 10.1016/j.metabol.2013.10.006. Epub 2013 Oct 24. — View Citation

Han TS, Lean ME. A clinical perspective of obesity, metabolic syndrome and cardiovascular disease. JRSM Cardiovasc Dis. 2016 Feb 25;5:2048004016633371. doi: 10.1177/2048004016633371. eCollection 2016 Jan-Dec. — View Citation

Hanley AJ, Karter AJ, Williams K, Festa A, D'Agostino RB Jr, Wagenknecht LE, Haffner SM. Prediction of type 2 diabetes mellitus with alternative definitions of the metabolic syndrome: the Insulin Resistance Atherosclerosis Study. Circulation. 2005 Dec 13;112(24):3713-21. doi: 10.1161/CIRCULATIONAHA.105.559633. — View Citation

Heymsfield SB, Harp JB, Reitman ML, Beetsch JW, Schoeller DA, Erondu N, Pietrobelli A. Why do obese patients not lose more weight when treated with low-calorie diets? A mechanistic perspective. Am J Clin Nutr. 2007 Feb;85(2):346-54. doi: 10.1093/ajcn/85.2.346. — View Citation

Hsu CN, Hou CY, Hsu WH, Tain YL. Early-Life Origins of Metabolic Syndrome: Mechanisms and Preventive Aspects. Int J Mol Sci. 2021 Nov 2;22(21):11872. doi: 10.3390/ijms222111872. — View Citation

Isomaa B, Almgren P, Tuomi T, Forsen B, Lahti K, Nissen M, Taskinen MR, Groop L. Cardiovascular morbidity and mortality associated with the metabolic syndrome. Diabetes Care. 2001 Apr;24(4):683-9. doi: 10.2337/diacare.24.4.683. — View Citation

Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. No abstract available. Erratum In: Circulation. 2014 Jun 24;129(25 Suppl 2):S139-40. — View Citation

Kalan Farmanfarma K, Kaykhaei MA, Adineh HA, Mohammadi M, Dabiri S, Ansari-Moghaddam A. Prevalence of metabolic syndrome in Iran: A meta-analysis of 69 studies. Diabetes Metab Syndr. 2019 Jan-Feb;13(1):792-799. doi: 10.1016/j.dsx.2018.11.055. Epub 2018 Dec 5. — View Citation

Laaksonen DE, Lakka HM, Salonen JT, Niskanen LK, Rauramaa R, Lakka TA. Low levels of leisure-time physical activity and cardiorespiratory fitness predict development of the metabolic syndrome. Diabetes Care. 2002 Sep;25(9):1612-8. doi: 10.2337/diacare.25.9.1612. — View Citation

Laule C, Atasoy D. Hunger potentiated. Cell Metab. 2023 May 2;35(5):723-725. doi: 10.1016/j.cmet.2023.04.005. — View Citation

Lowe DA, Wu N, Rohdin-Bibby L, Moore AH, Kelly N, Liu YE, Philip E, Vittinghoff E, Heymsfield SB, Olgin JE, Shepherd JA, Weiss EJ. Effects of Time-Restricted Eating on Weight Loss and Other Metabolic Parameters in Women and Men With Overweight and Obesity: The TREAT Randomized Clinical Trial. JAMA Intern Med. 2020 Nov 1;180(11):1491-1499. doi: 10.1001/jamainternmed.2020.4153. Erratum In: JAMA Intern Med. 2020 Nov 1;180(11):1555. JAMA Intern Med. 2021 Jun 1;181(6):883. — View Citation

Mottillo S, Filion KB, Genest J, Joseph L, Pilote L, Poirier P, Rinfret S, Schiffrin EL, Eisenberg MJ. The metabolic syndrome and cardiovascular risk a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Sep 28;56(14):1113-32. doi: 10.1016/j.jacc.2010.05.034. — View Citation

Pan WH, Flegal KM, Chang HY, Yeh WT, Yeh CJ, Lee WC. Body mass index and obesity-related metabolic disorders in Taiwanese and US whites and blacks: implications for definitions of overweight and obesity for Asians. Am J Clin Nutr. 2004 Jan;79(1):31-9. doi: 10.1093/ajcn/79.1.31. — View Citation

Perez-Martinez P, Mikhailidis DP, Athyros VG, Bullo M, Couture P, Covas MI, de Koning L, Delgado-Lista J, Diaz-Lopez A, Drevon CA, Estruch R, Esposito K, Fito M, Garaulet M, Giugliano D, Garcia-Rios A, Katsiki N, Kolovou G, Lamarche B, Maiorino MI, Mena-Sanchez G, Munoz-Garach A, Nikolic D, Ordovas JM, Perez-Jimenez F, Rizzo M, Salas-Salvado J, Schroder H, Tinahones FJ, de la Torre R, van Ommen B, Wopereis S, Ros E, Lopez-Miranda J. Lifestyle recommendations for the prevention and management of metabolic syndrome: an international panel recommendation. Nutr Rev. 2017 May 1;75(5):307-326. doi: 10.1093/nutrit/nux014. — View Citation

Ryan DH, Yockey SR. Weight Loss and Improvement in Comorbidity: Differences at 5%, 10%, 15%, and Over. Curr Obes Rep. 2017 Jun;6(2):187-194. doi: 10.1007/s13679-017-0262-y. — View Citation

Schulz LO, Bennett PH, Ravussin E, Kidd JR, Kidd KK, Esparza J, Valencia ME. Effects of traditional and western environments on prevalence of type 2 diabetes in Pima Indians in Mexico and the U.S. Diabetes Care. 2006 Aug;29(8):1866-71. doi: 10.2337/dc06-0138. — View Citation

Tsao YC, Li WC, Yeh WC, Ueng SW, Chiu SY, Chen JY. The Association between Metabolic Syndrome and Related Factors among the Community-Dwelling Indigenous Population in Taiwan. Int J Environ Res Public Health. 2020 Dec 2;17(23):8958. doi: 10.3390/ijerph17238958. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the metabolic syndrome severity score (Z score) after reduction > 5% body weight from baseline to 24 weeks	Metabolic syndrome severity will be measured by using Z score derived from Taiwan Biobank and Metabolic syndrome severity score (MSSS): MSSS calculation will be performed with the online tool "METS Severity Calculator" at ttp://publichealth.hsc.wvu.edu/biostatistics/metabolic-syndrome-severity-calculator/mets-severity-calculator/. The equations for calculation of MSSS are based on the NHANES study in the USA with the following arguments: age, race, gender, waist circumference, triglycerides (TG), high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, systolic blood pressure (SBP) and blood glucose levels.	24 weeks