Weekly ONe-Day WatER-only Fasting InterventionaL Trial for Low-Density Lipoprotein Cholesterol Reduction (WONDERFUL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02770313|
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : January 25, 2019
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)|
|Estimated Enrollment :||128 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|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||November 2019|
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
|Contact: Benjamin D Horne, PhD, MPHfirstname.lastname@example.org|
|Contact: Patti Spenceremail@example.com|
|United States, Utah|
|Intermountain Medical Center||Recruiting|
|Murray, Utah, United States, 84157|
|Contact: Benjamin Horne, PhD, MPH 801-507-4708 firstname.lastname@example.org|
|Contact: Patti Spencer, BS (801) 507-4778 email@example.com|
|Principal Investigator:||Benjamin D Horne, PhD, MPH||Intermountain Heart Institute|