Status:
COMPLETED
Effect of Time-Restricted Feeding on Fat Loss and Cardiometabolic Risk Factors in Overweight Adults
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Obesity
Eligibility:
All Genders
25-75 years
Phase:
NA
Brief Summary
Time-restricted feeding (TRF) is a novel type of intermittent fasting that involves eating within a daily period of 10 hours or less, followed by fasting for at least 14 hours daily. Several studies i...
Eligibility Criteria
Inclusion
- Are a new patient at the UAB Weight Loss Medicine Clinic
- Aged 25-75 years old
- BMI between 30-60 kg/m2 (inclusive)
- Weigh less than 450 lbs
- Wake up regularly between 4-9 am on most days.
Exclusion
- Diagnosed with diabetes, have an HbA1c of ≥6.5%, or are on diabetes medication
- On weight loss medication
- Addition of or withdrawal from a chronic medication within the past 10 weeks
- 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 (other than non-melanoma skin cancer) within the last 5 years
- Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)
- Lost or gained more than 5 lbs of weight in the past month
- Currently perform overnight shift work more than once per week on average
- Regularly eat within a less than 10-hour period each day
- Regularly eat dinner before 6 pm
- Traveled more than two time zones away in the two months prior to enrolling in the trial
- Will travel more than one time zone away during the study
- Pregnant or breastfeeding
Key Trial Info
Start Date :
July 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03459703
Start Date
July 12 2018
End Date
April 30 2020
Last Update
July 8 2020
Active Locations (1)
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1
UAB Weight Loss Medicine Clinic
Birmingham, Alabama, United States, 35205