The Effects of Water-only Fasting and Refeeding on Body Composition
NCT ID: NCT04514146
Last Updated: 2021-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
48 participants
OBSERVATIONAL
2020-08-15
2021-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Water-only Fasting Group
Overweight and obese, non-diabetic participants undergoing elective water-only fasting treatment
Water-only fasting
In-patient water-only fasting for at least 10 days followed by at least 5 days of refeeding
Interventions
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Water-only fasting
In-patient water-only fasting for at least 10 days followed by at least 5 days of refeeding
Eligibility Criteria
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Inclusion Criteria
* 40-70 years old
* Fasting plasma glucose \<126mg/dL and/or hemoglobin A1c \<7%
* BMI between 25 and 40 kg/m2
* Elect and qualify for a water-only fast of at least 10 consecutive days
* Provide informed consent
* Internet and computer access
* Able to return for 6-week follow-up visit
Exclusion Criteria
* Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's)
* Stroke or heart attack within the last 12 months
* Break water-only fast before 10 days with juice or food.
* Break water-only fast after 10 days with juice or food before end-of-fast blood draw occurs.
* Leave center before completing at least 5 days of refeeding
* Unable to lay still on the back for at least 10 min
* Abdominal metal implants
40 Years
70 Years
ALL
No
Sponsors
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TrueNorth Health Foundation
OTHER
Responsible Party
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Toshia Myers
Director
Principal Investigators
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Toshia R Myers, PhD
Role: PRINCIPAL_INVESTIGATOR
Director
Locations
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Toshia Myers
Santa Rosa, California, United States
Countries
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References
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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.
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.
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.
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.
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.
Patel P, Abate N. Body fat distribution and insulin resistance. Nutrients. 2013 Jun 5;5(6):2019-27. doi: 10.3390/nu5062019.
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.
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.
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.
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.
King LK, March L, Anandacoomarasamy A. Obesity & osteoarthritis. Indian J Med Res. 2013;138(2):185-93.
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.
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.
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.
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.
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.
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.
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.
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.
Johnstone AM. Fasting - the ultimate diet? Obes Rev. 2007 May;8(3):211-22. doi: 10.1111/j.1467-789X.2006.00266.x.
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.
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.
Other Identifiers
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TNHF2020-2VAT
Identifier Type: -
Identifier Source: org_study_id
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