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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Fasting | Experimental | Water-only Intermittent Fasting |
|
| Control | No Intervention | ad libitum Usual Diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Fasting | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change score of low density lipoprotein cholesterol | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change score for Homeostatic Model Assessment - Insulin Resistance | 26 weeks | |
| Change score for Metabolic Syndrome Score | 26 weeks | |
| Change score for brain-derived neurotrophic factor (BDNF) level |
| Measure | Description | Time Frame |
|---|---|---|
| Change score for gut microbiota composition based on 16S rDNA sequencing | 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. |
Inclusion Criteria:
Male or non-pregnant female, 21-70 years of age,
Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin D Horne, PhD, MPH | Intermountain Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40604163 | Derived | Horne BD, Anderson JL, May HT, Bair TL, Le VT, Iverson L, Knowlton KU, Muhlestein JB. Insulin resistance reduction, intermittent fasting, and human growth hormone: secondary analysis of a randomized trial. NPJ Metab Health Dis. 2024 Oct 3;2(1):26. doi: 10.1038/s44324-024-00025-2. | |
| 35919268 | Derived | Bartholomew CL, Muhlestein JB, May HT, Le VT, Galenko O, Garrett KD, Brunker C, Hopkins RO, Carlquist JF, Knowlton KU, Anderson JL, Bailey BW, Horne BD. Randomized controlled trial of once-per-week intermittent fasting for health improvement: the WONDERFUL trial. Eur Heart J Open. 2021 Sep 3;1(2):oeab026. doi: 10.1093/ehjopen/oeab026. eCollection 2021 Sep. |
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| 26 weeks |
| Change score for the MicroCog test's general cognitive proficiency index score | 26 weeks |
| 26 weeks |
| 35361560 | Derived | Horne BD, Anderson JL, May HT, Le VT, Galenko O, Drakos SG, Bair TL, Knowlton KU, Muhlestein JB. Intermittent fasting and changes in Galectin-3: A secondary analysis of a randomized controlled trial of disease-free subjects. Nutr Metab Cardiovasc Dis. 2022 Jun;32(6):1538-1548. doi: 10.1016/j.numecd.2022.03.001. Epub 2022 Mar 7. |