Weekly ONe-Day WatER-only Fasting InterventionaL Trial for Low-Density Lipoprotein Cholesterol Reduction

NCT02770313 | Completed

• 1 other identifier: 1050163
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Fasting

Outcome Measures

Primary Outcomes (1)

• Change score of low density lipoprotein cholesterol

  26 weeks

Secondary Outcomes (4)

• 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 Outcomes (1)

• Change score for gut microbiota composition based on 16S rDNA sequencing

  26 weeks

Study Arms (2)

Intermittent Fasting

EXPERIMENTAL

Water-only Intermittent Fasting

Behavioral: Intermittent Fasting

Control

NO INTERVENTION

ad libitum Usual Diet

Interventions

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).

Intermittent Fasting

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
• 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.
• 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.
• Refusal to drink water while fasting.
• 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).
• Pre-diabetics or diabetics on diabetes medication.
• Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Related Publications (3)

• 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.

  PMID: 40604163 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.

  PMID: 35919268 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.

  PMID: 35361560 DERIVED

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Benjamin D Horne, PhD, MPH

  Intermountain Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 12, 2016
• Study Start: October 1, 2016
• Primary Completion: February 19, 2020
• Study Completion: February 19, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)