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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04514146
Other study ID # TNHF2020-2VAT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 15, 2020
Est. completion date October 1, 2021

Study information

Verified date October 2021
Source TrueNorth Health Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Toshia Myers Santa Rosa California

Sponsors (1)

Lead Sponsor Collaborator
TrueNorth Health Foundation

Country where clinical trial is conducted

United States, 

References & Publications (22)

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Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
Primary 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 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
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