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Weekly ONe-Day WatER-only Fasting InterventionaL Trial for Low-Density Lipoprotein Cholesterol Reduction

NCT02770313 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2020-07-17

No results posted yet for this study

Summary

The goal of this study is to determine how effective repeated fasting over 26 weeks (6 months) is at improving risk parameters that are surrogate endpoints for cardiovascular diseases, metabolic dysregulation and cognitive impairments.

Subjects will be randomized 1:1 to water-only fasting or to their ad libitum usual diet, with randomization performed within strata based on fasting history (≤180 hours or 181-720 hours of total fasting for \>12 consecutive hours per episode in the previous two years). Subjects will be assessed at 4, 13 and 26 weeks following randomization.

Conditions

  • Intermittent Fasting

Interventions

BEHAVIORAL

Intermittent Fasting

Subjects allocated to the fasting arm will undergo a fasting regimen of twice-per-week 24-hour fasting on non-consecutive days during the first 4 weeks of the study, then once-per-week 24-hour fasting during the rest of the study (22 weeks).

Sponsors & Collaborators

  • Intermountain Health Care, Inc.

    lead OTHER

Principal Investigators

  • Benjamin D Horne, PhD, MPH · Intermountain Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2020-02-19
Completion
2020-02-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02770313 on ClinicalTrials.gov