Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

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.


Condition or disease Intervention/treatment Phase
Intermittent Fasting Behavioral: Intermittent Fasting Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change score of low density lipoprotein cholesterol [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Change score for Homeostatic Model Assessment - Insulin Resistance [ Time Frame: 26 weeks ]
  2. Change score for Metabolic Syndrome Score [ Time Frame: 26 weeks ]
  3. Change score for brain-derived neurotrophic factor (BDNF) level [ Time Frame: 26 weeks ]
  4. Change score for the MicroCog test's general cognitive proficiency index score [ Time Frame: 26 weeks ]

Other Outcome Measures:
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  1. Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception. Women who become pregnant after enrollment in the study will be withdrawn for the health of the mother and baby.
  2. Individuals who have fasted more than 15 hours per episode more than once per month during the past two years (i.e., >720 hours over two years), except for those who fast during multiple weeks once per year (e.g., Muslim, Baha'i) who will be allowed to begin participation starting at two weeks after their preferred annual period of fasting ends (e.g., Ramadan or the Baha'i fast) and ending at six months prior to the beginning of the next annual observance, as long as they do not fast routinely outside of the one annual period of fasting.
  3. Refusal to drink water while fasting.
  4. Prior diagnosis of a chronic disease (i.e., defined as symptomatic coronary artery disease, coronary revascularization, myocardial infarction, unstable angina, stroke, transient ischemic attack, pulmonary embolism, peripheral vascular thromboembolism, chronic kidney disease stage III or higher, chronic obstructive pulmonary disease, immunodeficiency, solid organ transplant, eating disorder, type I diabetes, dementia, traumatic brain injury including post-concussive syndrome, and cancer of any type within the last 5 years other than cancer of the skin excluding melanoma).
  5. Pre-diabetics or diabetics on diabetes medication.
  6. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
  7. Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Benjamin D Horne, PhD, MPH 801-507-4708 benjamin.horne@imail.org
Contact: Patti Spencer 801-507-4778 patti.spencer@imail.org

Locations
Layout table for location information
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Benjamin Horne, PhD, MPH    801-507-4708    benjamin.horne@imail.org   
Contact: Patti Spencer, BS    (801) 507-4778    patti.spencer@imail.org   
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Benjamin D Horne, PhD, MPH Intermountain Heart Institute

Layout table for additonal information
Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT02770313     History of Changes
Other Study ID Numbers: 1050163
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No