Weekly ONe-Day WatER-only Fasting InterventionaL Trial for Low-Density Lipoprotein Cholesterol Reduction (WONDERFUL)
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|ClinicalTrials.gov Identifier: NCT02770313|
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : July 17, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Intermittent Fasting||Behavioral: Intermittent Fasting||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Weekly ONe-Day WatER-only Fasting InterventionaL Trial for Low-Density Lipoprotein Cholesterol Reduction|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||February 19, 2020|
|Actual Study Completion Date :||February 19, 2020|
Experimental: Intermittent Fasting
Water-only Intermittent Fasting
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).
No Intervention: Control
ad libitum Usual Diet
- Change score of low density lipoprotein cholesterol [ Time Frame: 26 weeks ]
- Change score for Homeostatic Model Assessment - Insulin Resistance [ Time Frame: 26 weeks ]
- Change score for Metabolic Syndrome Score [ Time Frame: 26 weeks ]
- Change score for brain-derived neurotrophic factor (BDNF) level [ Time Frame: 26 weeks ]
- Change score for the MicroCog test's general cognitive proficiency index score [ Time Frame: 26 weeks ]
- Change score for gut microbiota composition based on 16S rDNA sequencing [ Time Frame: 26 weeks ]
Change score for gut microbiota composition based on 16S rDNA sequencing among N=30 participants who opt in to this pre-specified substudy.
Shannon's diversity index will be used because it measures the uncertainty in finding a specific type of microbe from one that is randomly selected from a stool sample. The index ranges from 0 to infinity. A higher value indicates that more diversity in species exists in the stool sample. It is calculated as negative one multiplied by the sum across each species of the proportion of the whole that the species constitutes in the stool multiplied by the natural log of that proportion. The change score will be the value at week 26 minus the value at baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770313
|United States, Utah|
|Intermountain Medical Center|
|Murray, Utah, United States, 84157|
|Principal Investigator:||Benjamin D Horne, PhD, MPH||Intermountain Heart Institute|