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

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ClinicalTrials.gov Identifier: NCT03504683
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Courtney M Peterson, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE April 20, 2018
Last Update Posted Date July 23, 2019
Estimated Study Start Date  ICMJE August 30, 2019
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2018)
  • Mean 24-hour glucose levels [ Time Frame: 10 weeks ]
    Mean 24-hour glucose levels (mg/dl)
  • Mean 24-hour insulin levels [ Time Frame: 10 weeks ]
    Mean 24-hour insulin levels (mU/l)
  • Mean 24-hour C-peptide levels [ Time Frame: 10 weeks ]
    Mean 24-hour C-peptide levels (pmol/l). This is also a proxy for total 24-hour insulin secretion.
  • Insulin sensitivity [ Time Frame: 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
  • Beta-cell responsivity index (a measure of beta-cell function) [ Time Frame: 10 weeks ]
    Mean value of beta-cell responsivity across the three identical meal tolerance tests, as measured by the Oral Minimal Model
  • Glucose AUCs [ Time Frame: 10 weeks ]
    Glucose area-under-the-curve (mg/dl x hr) during each of three identical meal tolerance tests within a 24-hour period
  • Insulin AUC [ Time Frame: 10 weeks ]
    Insulin area-under-the-curve (mU/l x hr) during each of three identical meal tolerance tests within a 24-hour period
  • C-peptide AUC [ Time Frame: 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
  • Peak glucose and mean amplitude of glycemic excursions (MAGE) glucose values [ Time Frame: 10 weeks ]
    mg/dl
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03504683 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2018)
  • Mean 24-hour systolic and diastolic blood pressure [ Time Frame: 10 weeks ]
    mmHg
  • Daily maximum value, minimum value, and amplitude of systolic and diastolic blood pressure [ Time Frame: 10 weeks ]
    mmHg
  • Percentage of individuals with non-dipping blood pressure phenotypes [ Time Frame: 10 weeks ]
  • Heart Rate [ Time Frame: 10 weeks ]
    beats per minute
  • Lipids [ Time Frame: 10 weeks ]
    Total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl)
  • High Sensitivity C-Reactive Protein (hs-CRP) [ Time Frame: 10 weeks ]
    mg/l
  • Cortisol [ Time Frame: 10 weeks ]
    μg/dl
  • 8-isoprostane [ Time Frame: 10 weeks ]
    pg/ml
  • Inflammatory biomarkers [ Time Frame: 10 weeks ]
    TNF-alpha, IL-1beta, IL-4, IL-6, IL-10 (in pg/ml)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 12, 2018)
  • Fat mass and lean mass [ Time Frame: 10 weeks ]
    Changes in fat mass and lean mass as measured by dual-energy X-ray absorptiometry (DXA)
  • Body weight [ Time Frame: 10 weeks ]
    Change in body weight (kg) as measured by scale weight
  • Bone mineral density [ Time Frame: 10 weeks ]
    Changes in bone mineral density (g/cm^2) as measured by dual-energy X-ray absorptiometry (DXA)
  • Chronotype [ Time Frame: 10 weeks ]
    Chronotype (i.e., mid-point of sleep in clock time) as measured by the Munich Chronotype Questionnaire
  • Sleep Quality [ Time Frame: 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.)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors
Official Title  ICMJE Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors in Adults With Prediabetes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE PreDiabetes
Intervention  ICMJE
  • 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
  • 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
  • Behavioral: Control Schedule
    Eat between 8 am - 8 pm (or 7 am - 7 pm, if an early riser)
Study Arms  ICMJE
  • Experimental: Early Time-Restricted Feeding
    Intervention: Behavioral: Early Time-Restricted Feeding
  • Experimental: Mid-day Time-Restricted Feeding
    Intervention: Behavioral: Mid-day Time-Restricted Feeding
  • Placebo Comparator: Control Schedule
    Intervention: Behavioral: Control Schedule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2018)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2023
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Courtney M. Peterson, Ph.D. 205-934-0122 cpeterso@uab.edu
Contact: Humaira Jamshed, Ph.D. 205-934-5458 humairaj@uab.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03504683
Other Study ID Numbers  ICMJE IRB-300001180
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Courtney M Peterson, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Courtney M. Peterson, Ph.D. University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP