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This observational pilot study will assess the effects of water-only fasting on body composition and insulin resistance
This pilot study will explore the effects of water-only fasting followed by an exclusively whole-plant-food diet free of added salt, oil, and sugar on body composition with a particular focus on visceral adipose tissue (VAT). The study will also extend a previous study assessing the effects of fasting and refeeding on Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) values and markers of cardiovascular health and inflammation by following participants for an additional 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water-only Fasting Group | Overweight and obese, non-diabetic participants undergoing elective water-only fasting treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water-only fasting | Other | In-patient water-only fasting for at least 10 days followed by at least 5 days of refeeding |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean changes in visceral adipose tissue from baseline | Visceral adipose tissue will be estimated using Holigic Horizon dual-energy X-ray absorptiometry (DXA) machine and reported in grams | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed |
| Measure | Description | Time Frame |
|---|---|---|
| Mean changes in total fat and lean mass and bone mineral content (BMC) from baseline | Total fat and lean mass and BMC will be estimated using Holigic Horizon dual-energy X-ray absorptiometry (DXA) machine and reported in grams | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed |
| Measure | Description | Time Frame |
|---|---|---|
| Mean changes in lipid profile from baseline | Lipid profile will be assessed using serum to measure cholesterol, triglycerides, high-density lipoprotein (HDL), and lowdensity lipoprotein (LDL) and reported in mg/dL | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed |
Inclusion Criteria:
Exclusion Criteria:
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Overweight and obese, non-diabetic participants chosen from voluntary patients
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| Name | Affiliation | Role |
|---|---|---|
| Toshia R Myers, PhD | Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toshia Myers | Santa Rosa | California | 95404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19656312 | Background | Ibrahim MM. Subcutaneous and visceral adipose tissue: structural and functional differences. Obes Rev. 2010 Jan;11(1):11-8. doi: 10.1111/j.1467-789X.2009.00623.x. Epub 2009 Jul 28. | |
| 23583168 | Background | Tchkonia T, Thomou T, Zhu Y, Karagiannides I, Pothoulakis C, Jensen MD, Kirkland JL. Mechanisms and metabolic implications of regional differences among fat depots. Cell Metab. 2013 May 7;17(5):644-656. doi: 10.1016/j.cmet.2013.03.008. Epub 2013 Apr 11. |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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sera and plasma
| Mean changes in weight from baseline |
Weight will be measured on a digital scale and reported in kilograms (kg) |
| Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed |
| Mean changes in insulin resistance from baseline | Insulin resistance will be assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) [fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5] | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed |
| Mean changes in abdominal circumference from baseline | Abdominal circumference will be measured on bare skin at the minimal waistline with a tension-sensitive, non-elastic tape and reported in centimeters (cm) | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed |
| Mean changes in high sensitivity C-reactive protein (hs-CRP) from baseline | hsCRP will assessed using serum and reported in mg/L | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed |
| Mean changes in Gamma-Glutamyl-Transferase (GGT) from baseline | GGT will assessed using serum and reported in U/L | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after end of refeed |
| 29995306 | Background | Unamuno X, Gomez-Ambrosi J, Rodriguez A, Becerril S, Fruhbeck G, Catalan V. Adipokine dysregulation and adipose tissue inflammation in human obesity. Eur J Clin Invest. 2018 Sep;48(9):e12997. doi: 10.1111/eci.12997. Epub 2018 Aug 3. |
| 21937614 | Background | Shuster A, Patlas M, Pinthus JH, Mourtzakis M. The clinical importance of visceral adiposity: a critical review of methods for visceral adipose tissue analysis. Br J Radiol. 2012 Jan;85(1009):1-10. doi: 10.1259/bjr/38447238. Epub 2011 Sep 21. |
| 29338526 | Background | de Mutsert R, Gast K, Widya R, de Koning E, Jazet I, Lamb H, le Cessie S, de Roos A, Smit J, Rosendaal F, den Heijer M. Associations of Abdominal Subcutaneous and Visceral Fat with Insulin Resistance and Secretion Differ Between Men and Women: The Netherlands Epidemiology of Obesity Study. Metab Syndr Relat Disord. 2018 Feb;16(1):54-63. doi: 10.1089/met.2017.0128. Epub 2018 Jan 17. |
| 23739143 | Background | Patel P, Abate N. Body fat distribution and insulin resistance. Nutrients. 2013 Jun 5;5(6):2019-27. doi: 10.3390/nu5062019. |
| 30618514 | Background | Moon HU, Ha KH, Han SJ, Kim HJ, Kim DJ. The Association of Adiponectin and Visceral Fat with Insulin Resistance and beta-Cell Dysfunction. J Korean Med Sci. 2018 Dec 26;34(1):e7. doi: 10.3346/jkms.2019.34.e7. eCollection 2019 Jan 7. |
| 25593845 | Background | Gutch M, Kumar S, Razi SM, Gupta KK, Gupta A. Assessment of insulin sensitivity/resistance. Indian J Endocrinol Metab. 2015 Jan-Feb;19(1):160-4. doi: 10.4103/2230-8210.146874. |
| 23300589 | Background | Gast KB, Tjeerdema N, Stijnen T, Smit JW, Dekkers OM. Insulin resistance and risk of incident cardiovascular events in adults without diabetes: meta-analysis. PLoS One. 2012;7(12):e52036. doi: 10.1371/journal.pone.0052036. Epub 2012 Dec 28. |
| 30170598 | Background | Ormazabal V, Nair S, Elfeky O, Aguayo C, Salomon C, Zuniga FA. Association between insulin resistance and the development of cardiovascular disease. Cardiovasc Diabetol. 2018 Aug 31;17(1):122. doi: 10.1186/s12933-018-0762-4. |
| 24056594 | Background | King LK, March L, Anandacoomarasamy A. Obesity & osteoarthritis. Indian J Med Res. 2013;138(2):185-93. |
| 20379148 | Background | Utzschneider KM, Van de Lagemaat A, Faulenbach MV, Goedecke JH, Carr DB, Boyko EJ, Fujimoto WY, Kahn SE. Insulin resistance is the best predictor of the metabolic syndrome in subjects with a first-degree relative with type 2 diabetes. Obesity (Silver Spring). 2010 Sep;18(9):1781-7. doi: 10.1038/oby.2010.77. Epub 2010 Apr 8. |
| 16127767 | Background | Jee SH, Kim HJ, Lee J. Obesity, insulin resistance and cancer risk. Yonsei Med J. 2005 Aug 31;46(4):449-55. doi: 10.3349/ymj.2005.46.4.449. |
| 28148928 | Background | Merlotti C, Ceriani V, Morabito A, Pontiroli AE. Subcutaneous fat loss is greater than visceral fat loss with diet and exercise, weight-loss promoting drugs and bariatric surgery: a critical review and meta-analysis. Int J Obes (Lond). 2017 May;41(5):672-682. doi: 10.1038/ijo.2017.31. Epub 2017 Feb 2. |
| 18180786 | Background | Chaston TB, Dixon JB. Factors associated with percent change in visceral versus subcutaneous abdominal fat during weight loss: findings from a systematic review. Int J Obes (Lond). 2008 Apr;32(4):619-28. doi: 10.1038/sj.ijo.0803761. Epub 2008 Jan 8. |
| 27754807 | Background | Gomez-Arbelaez D, Bellido D, Castro AI, Ordonez-Mayan L, Carreira J, Galban C, Martinez-Olmos MA, Crujeiras AB, Sajoux I, Casanueva FF. Body Composition Changes After Very-Low-Calorie Ketogenic Diet in Obesity Evaluated by 3 Standardized Methods. J Clin Endocrinol Metab. 2017 Feb 1;102(2):488-498. doi: 10.1210/jc.2016-2385. |
| 15530168 | Background | Freedland ES. Role of a critical visceral adipose tissue threshold (CVATT) in metabolic syndrome: implications for controlling dietary carbohydrates: a review. Nutr Metab (Lond). 2004 Nov 5;1(1):12. doi: 10.1186/1743-7075-1-12. |
| 31277506 | Background | Romano L, Marchetti M, Gualtieri P, Di Renzo L, Belcastro M, De Santis GL, Perrone MA, De Lorenzo A. Effects of a Personalized VLCKD on Body Composition and Resting Energy Expenditure in the Reversal of Diabetes to Prevent Complications. Nutrients. 2019 Jul 4;11(7):1526. doi: 10.3390/nu11071526. |
| 29629240 | Background | Liu FX, Flatt SW, Nichols JF, Pakiz B, Barkai HS, Wing DR, Heath DD, Rock CL. Factors Associated with Visceral Fat Loss in Response to a Multifaceted Weight Loss Intervention. J Obes Weight Loss Ther. 2017;7(4):346. doi: 10.4172/2165-7904.1000346. Epub 2017 Aug 14. |
| 17444963 | Background | Johnstone AM. Fasting - the ultimate diet? Obes Rev. 2007 May;8(3):211-22. doi: 10.1111/j.1467-789X.2006.00266.x. |
| 28625918 | Background | Shepherd JA, Ng BK, Sommer MJ, Heymsfield SB. Body composition by DXA. Bone. 2017 Nov;104:101-105. doi: 10.1016/j.bone.2017.06.010. Epub 2017 Jun 16. |
| 29458369 | Background | Finnell JS, Saul BC, Goldhamer AC, Myers TR. Is fasting safe? A chart review of adverse events during medically supervised, water-only fasting. BMC Complement Altern Med. 2018 Feb 20;18(1):67. doi: 10.1186/s12906-018-2136-6. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |