Effect of Time-Restricted Feeding on 24-hour Glycemic Control, Blood Pressure, and Cardiovascular Disease Risk Factors
Purpose
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
- PreDiabetes
Eligibility
- Eligible Ages
- Between 30 Years and 65 Years
- Eligible Genders
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- 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.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Early Time-Restricted Feeding |
|
|
|
Experimental Mid-day Time-Restricted Feeding |
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|
Placebo Comparator Control Schedule |
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Recruiting Locations
Birmingham, Alabama 35294
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham