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Visceral ObesityNCT04514146

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

An observational study of Visceral Obesity and Insulin Resistance, run by TrueNorth Health Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Visceral Obesity, Insulin Resistance
What is being tested?
Water-only fasting
How many people
48 participants
Where
1 siteUnited States
Study dates
15 Aug 2020to 1 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • Any gender
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Toshia Myers

    Santa Rosa, California, 95404

Other trials in United States

About this study

Official title: A Pilot Study on the Effects of Water-only Fasting and Refeeding on Body Composition and Insulin Resistance

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

Read the detailed description

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.

Being tested
Water-only fasting
Keywords
water-only fasting, HOMA-IR, insulin resistance, visceral adipose tissue
Medical subject headings
Obesity, Abdominal, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Water-only fastingOther

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

Study groups in NCT04514146
Study groupRoleWhat they receive
Water-only Fasting GroupOverweight and obese, non-diabetic participants undergoing elective water-only fasting treatment
Receives: Other: Water-only fasting

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2020
  2. Study start15 Aug 2020
  3. Primary completion1 Oct 2021
  4. Study completion1 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04514146
Sponsor's protocol ID
TNHF2020-2VAT
Status last verified
Oct 2021
First submitted
12 Aug 2020
Last updated
6 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19656312

  • 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.

    PubMed 23583168

  • 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.

    PubMed 29995306

  • 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.

    PubMed 21937614

  • 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.

    PubMed 29338526

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

    PubMed 23739143

  • 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.

    PubMed 30618514

  • 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.

    PubMed 25593845

  • 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.

    PubMed 23300589

  • 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.

    PubMed 30170598

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

    PubMed 24056594

  • 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.

    PubMed 20379148

  • 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.

    PubMed 16127767

  • 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.

    PubMed 28148928

  • 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.

    PubMed 18180786

Questions about this trial

What is this clinical trial studying?

An observational study of Visceral Obesity and Insulin Resistance, run by TrueNorth Health Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean changes in visceral adipose tissue from baseline (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04514146, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.

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