Intermittent Fasting
Conditions
Brief 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.
Interventions
BEHAVIORALIntermittent 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
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant female, 21-70 years of age, * who are not currently taking a statin medication, * who have either pre-diabetes (clinical diagnosis, hemoglobin A1c ≥5.6%, or untreated fasting glucose \> 100 mg/dL within 6 months of screening) and are not taking medications to control diabetes OR diagnosed, diet-controlled type 2 diabetes but do not require medications to control diabetes OR one or more of the components of the metabolic syndrome measured within 6 months of screening (other than fasting glucose level \>100 mg/dL, i.e.: 1. systolic blood pressure ≥130 mmHg, or diastolic ≥85 mmHg, or use of an antihypertensive medication, 2. high-density lipoprotein cholesterol \<40 mg/dL for males or \<50 mg/dL for females, 3. triglycerides ≥150 mg/dL or use of a non-statin triglyceride-lowering medication (e.g., fibrate, niacin), 4. waist circumference ≥40 inches (102 cm) for males or ≥35 inches (88 cm) for females, or body mass index \>25 kg/m2), * are 21-39 years of age with LDL-C (measured within six months of screening) of 90-189 mg/dL OR are 40-70 years of age with LDL-C of 90-159 mg/dL OR are 21-70 years of age with LDL-C of 90 mg/dL or greater who have tried statins and stopped due to intolerance to the medications or who have one or more contraindications to statins and thus cannot take them but meet other study inclusion and
Exclusion criteria
. 2. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change score of low density lipoprotein cholesterol | 26 weeks |
Secondary
| Measure | 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 | 26 weeks |
| Change score for the MicroCog test's general cognitive proficiency index score | 26 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change score for gut microbiota composition based on 16S rDNA sequencing | 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. |
Countries
United States
Outcome results
None listed