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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

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
PreDiabetes Behavioral: Early Time-Restricted Feeding Behavioral: Mid-day Time-Restricted Feeding Behavioral: Control Schedule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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)




Primary Outcome Measures :
  1. Mean 24-hour glucose levels [ Time Frame: 10 weeks ]
    Mean 24-hour glucose levels (mg/dl)

  2. Mean 24-hour insulin levels [ Time Frame: 10 weeks ]
    Mean 24-hour insulin levels (mU/l)

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Peak glucose and mean amplitude of glycemic excursions (MAGE) glucose values [ Time Frame: 10 weeks ]
    mg/dl


Secondary Outcome Measures :
  1. Mean 24-hour systolic and diastolic blood pressure [ Time Frame: 10 weeks ]
    mmHg

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

  3. Percentage of individuals with non-dipping blood pressure phenotypes [ Time Frame: 10 weeks ]
  4. Heart Rate [ Time Frame: 10 weeks ]
    beats per minute

  5. Lipids [ Time Frame: 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) [ Time Frame: 10 weeks ]
    mg/l

  7. Cortisol [ Time Frame: 10 weeks ]
    μg/dl

  8. 8-isoprostane [ Time Frame: 10 weeks ]
    pg/ml

  9. Inflammatory biomarkers [ Time Frame: 10 weeks ]
    TNF-alpha, IL-1beta, IL-4, IL-6, IL-10 (in pg/ml)


Other Outcome Measures:
  1. 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)

  2. Body weight [ Time Frame: 10 weeks ]
    Change in body weight (kg) as measured by scale weight

  3. Bone mineral density [ Time Frame: 10 weeks ]
    Changes in bone mineral density (g/cm^2) as measured by dual-energy X-ray absorptiometry (DXA)

  4. Chronotype [ Time Frame: 10 weeks ]
    Chronotype (i.e., mid-point of sleep in clock time) as measured by the Munich Chronotype Questionnaire

  5. 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.)



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03504683


Contacts
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Contact: Courtney M. Peterson, Ph.D. 205-934-0122 cpeterso@uab.edu
Contact: Humaira Jamshed, Ph.D. 205-934-5458 humairaj@uab.edu

Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Courtney M. Peterson, Ph.D. University of Alabama at Birmingham

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Responsible Party: Courtney M Peterson, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03504683     History of Changes
Other Study ID Numbers: IRB-300001180
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cardiovascular Diseases
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia