The Effects of Water-only Fasting and Refeeding on Body Composition

NCT04514146 | Completed

• 1 other identifier: TNHF2020-2VAT
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This observational pilot study will assess the effects of water-only fasting on body composition and insulin resistance

Conditions

Visceral Obesity; Insulin Resistance

Keywords

water-only fasting; HOMA-IR; insulin resistance; visceral adipose tissue

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Mean changes in total fat and lean mass and bone mineral content (BMC) from baseline

  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

Other Outcomes (6)

• Mean changes in lipid profile from baseline

  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 weight from baseline

  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

  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

Study Arms (1)

Water-only Fasting Group

Overweight and obese, non-diabetic participants undergoing elective water-only fasting treatment

Other: Water-only fasting

Interventions

Water-only fasting OTHER

In-patient water-only fasting for at least 10 days followed by at least 5 days of refeeding

Water-only Fasting Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Overweight and obese, non-diabetic participants chosen from voluntary patients

You may qualify if:

• Any gender
• 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

You may not qualify if:

• Active malignancy
• 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

Sponsors & Collaborators

• TrueNorth Health Foundation: lead

Study Sites (1)

Toshia Myers

Santa Rosa, California, 95404, United States

Location

Related Publications (22)

• 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.

  PMID: 19656312 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.

  PMID: 23583168 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.

  PMID: 29995306 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.

  PMID: 21937614 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.

  PMID: 29338526 BACKGROUND

• Patel P, Abate N. Body fat distribution and insulin resistance. Nutrients. 2013 Jun 5;5(6):2019-27. doi: 10.3390/nu5062019.

  PMID: 23739143 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.

  PMID: 30618514 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.

  PMID: 25593845 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.

  PMID: 23300589 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.

  PMID: 30170598 BACKGROUND

• King LK, March L, Anandacoomarasamy A. Obesity & osteoarthritis. Indian J Med Res. 2013;138(2):185-93.

  PMID: 24056594 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.

  PMID: 20379148 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.

  PMID: 16127767 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.

  PMID: 28148928 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.

  PMID: 18180786 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.

  PMID: 27754807 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.

  PMID: 15530168 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.

  PMID: 31277506 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.

  PMID: 29629240 BACKGROUND

• Johnstone AM. Fasting - the ultimate diet? Obes Rev. 2007 May;8(3):211-22. doi: 10.1111/j.1467-789X.2006.00266.x.

  PMID: 17444963 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.

  PMID: 28625918 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.

  PMID: 29458369 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

sera and plasma

MeSH Terms

Conditions

Obesity, Abdominal; Insulin Resistance

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Toshia R Myers, PhD

  Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 14, 2020
• Study Start: August 15, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

US (1)