Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT03504683
Collaborator
(none)
144
1
3
45.4
3.2

Study Details

Study Description

Brief Summary

One in three American adults have prediabetes, and up to 70% of adults with prediabetes eventually develop type 2 diabetes. With the high cost of treating diabetes, cost-effective approaches are needed to reduce the incidence of diabetes. One new strategy may be to change when people eat. Studies in rodents suggest that a form of intermittent fasting that limits eating to a short time period each day and involves fasting for the rest of the day (time-restricted feeding; TRF) improves blood sugar control and cardiovascular health. Preliminary studies suggest that TRF also improves blood sugar, weight loss, and cardiovascular health in humans. This study will be the first full-scale, controlled feeding trial to determine whether TRF can improve 24-hour blood sugar control, 24-hour blood pressure, and cardiovascular disease risk factors even when food intake is matched to the control group. This clinical trial will also determine whether the benefits of TRF depend on the time of day that people eat. Participants will be assigned to one of three groups: (1) 'Early TRF' (eat between ~8 am-3 pm), (2) 'Mid-day TRF' (eat between ~1 pm - 8 pm), or (3) Control Schedule (~8 am - 8 pm) for 10 weeks. All food will be provided and matched between groups.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Early Time-Restricted Feeding
  • Behavioral: Mid-day Time-Restricted Feeding
  • Behavioral: Control Schedule
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomization will be stratified by fasting insulin. Within the lowest insulin strata, randomization will be further stratified by biological sex.Randomization will be stratified by fasting insulin. Within the lowest insulin strata, randomization will be further stratified by biological sex.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes
Actual Study Start Date :
Aug 17, 2020
Anticipated Primary Completion Date :
May 30, 2024
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Early Time-Restricted Feeding

Behavioral: Early Time-Restricted Feeding
Eat between 8 am - 3 pm (or 7 am - 2 pm, if an early riser)
Other Names:
  • eTRF
  • Early TRF
  • Experimental: Mid-day Time-Restricted Feeding

    Behavioral: Mid-day Time-Restricted Feeding
    Eat between 1 pm - 8 pm (or 12 pm - 7 pm, if an early riser)
    Other Names:
  • mTRF
  • Mid-day TRF
  • Placebo Comparator: Control Schedule

    Behavioral: Control Schedule
    Eat between 8 am - 8 pm (or 7 am - 7 pm, if an early riser)

    Outcome Measures

    Primary Outcome Measures

    1. Mean 24-hour glucose levels [10 weeks]

      Mean 24-hour glucose levels (mg/dl)

    2. Mean 24-hour insulin levels [10 weeks]

      Mean 24-hour insulin levels (mU/l)

    3. Mean 24-hour C-peptide levels [10 weeks]

      Mean 24-hour C-peptide levels (pmol/l). This is also a proxy for total 24-hour insulin secretion.

    4. Insulin sensitivity [10 weeks]

      Mean value of insulin sensitivity (dl/kg/min/μU/ml) across the three identical meal tolerance tests, as measured by the Oral Minimal Model

    5. Beta-cell responsivity index (a measure of beta-cell function) [10 weeks]

      Mean value of beta-cell responsivity across the three identical meal tolerance tests, as measured by the Oral Minimal Model

    6. Glucose AUCs [10 weeks]

      Glucose area-under-the-curve (mg/dl x hr) during each of three identical meal tolerance tests within a 24-hour period

    7. Insulin AUC [10 weeks]

      Insulin area-under-the-curve (mU/l x hr) during each of three identical meal tolerance tests within a 24-hour period

    8. C-peptide AUC [10 weeks]

      C-peptide area-under-the-curve (pmol/l x hr) during each of three identical meal tolerance tests within a 24-hour period

    9. Peak glucose and mean amplitude of glycemic excursions (MAGE) glucose values [10 weeks]

      mg/dl

    Secondary Outcome Measures

    1. Mean 24-hour systolic and diastolic blood pressure [10 weeks]

      mmHg

    2. Daily maximum value, minimum value, and amplitude of systolic and diastolic blood pressure [10 weeks]

      mmHg

    3. Percentage of individuals with non-dipping blood pressure phenotypes [10 weeks]

    4. Heart Rate [10 weeks]

      beats per minute

    5. Lipids [10 weeks]

      Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)

    6. High Sensitivity C-Reactive Protein (hs-CRP) [10 weeks]

      mg/l

    7. Cortisol [10 weeks]

      μg/dl

    8. 8-isoprostane [10 weeks]

      pg/ml

    9. Inflammatory biomarkers [10 weeks]

      TNF-alpha, IL-1beta, IL-4, IL-6, IL-10 (in pg/ml)

    Other Outcome Measures

    1. Fat mass and lean mass [10 weeks]

      Changes in fat mass and lean mass as measured by dual-energy X-ray absorptiometry (DXA)

    2. Body weight [10 weeks]

      Change in body weight (kg) as measured by scale weight

    3. Bone mineral density [10 weeks]

      Changes in bone mineral density (g/cm^2) as measured by dual-energy X-ray absorptiometry (DXA)

    4. Chronotype [10 weeks]

      Chronotype (i.e., mid-point of sleep in clock time) as measured by the Munich Chronotype Questionnaire

    5. Sleep Quality [10 weeks]

      Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PQSI) (This study will use the Global PQSI score, which ranges from 0-21, where higher values correspond to worse sleep quality.)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Aged 30-65 years old

    • Prediabetic as determined by HbA1c between 5.7-6.4% or fasting glucose between 100-125 mg/dl

    • BMI between 27-43 kg/m^2

    • Wake up at a regular time between 5-8 am

    Exclusion Criteria:
    • On diabetes medication or any medication known to affect glucose or blood pressure

    • Change in the dosage of a chronic medication within the past 3 months

    • Have a clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)

    • Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones

    • Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise the participant's safety or data validity

    • Evidence of cancer within the last 5 years

    • Pregnant or breastfeeding

    • Diagnosed psychiatric conditions

    • Sleep disorder, circadian disorder, or regularly sleep less than 6 hours per night

    • Currently, perform overnight shift work

    • Regularly eat within a <9-hour period each day

    • Lost or gained more than 3 kg of weight in the past 3 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294

    Sponsors and Collaborators

    • University of Alabama at Birmingham

    Investigators

    • Principal Investigator: Courtney M. Peterson, Ph.D., University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Courtney M Peterson, Assistant Professor, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT03504683
    Other Study ID Numbers:
    • IRB-300001180
    First Posted:
    Apr 20, 2018
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 19, 2022