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NCT07634926
Early Time-Restricted Eating for Cardiovascular Health
Conditions: Hypertension, Breakfast Skipper
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: University of Alabama at Birmingham
Location: University of Alabama at Birmingham Birmingham Alabama
Summary
This study will examine whether eating earlier in the day within a consistent 8-hour eating window can improve heart and blood vessel health in older adults with high blood pressure who often skip breakfast. Participants will be randomly assigned to either follow an early time-restricted eating schedule or continue their usual eating habits for 12 weeks. Researchers will measure blood pressure, blood vessel function, and biological markers related to the body's internal clock and oxidative stress to better understand how meal timing affects cardiovascular health.
Eligibility Criteria
Inclusion Criteria:
* Men and women ≥ 60 years old
* Average office systolic BP ≥130 mmHg5
* Self-reported skipping breakfast for at least 3 days in the past 7 days
* Identified as having a morning or evening chronotype according to the Morningness-Eveningness Questionnaire68
* Stable health history over the past 2 months
* Stable medication history over the past 2 months, as recommended by the primary provider
* Willing and able to provide informed consent.
Exclusion Criteria:
* Fasting \>13 hours per day
* Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake
* Resting heart rate of \>120 beats/minute, systolic BP \>180 and/or diastolic BP \>100 mmHg
* Have lost ≥ 10 pounds in last 3 months
* Self-reported exercise over 90 min/week
* Unable to wake up at a regular time between 6-9 am
* Perform overnight shift work more than 1day/week on average
* Have been diagnosed with diabetes
* On insulin or diabetes medication
* Unstable angina, heart attack or stroke in the past 3 months
* Continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure
* Pregnant or breastfeeding
* Rheumatoid arthritis, Parkinson's disease or currently on dialysis
* Current diagnosis of a major psychiatric condition that would impair study participation
* Severe gastrointestinal disease, major gastrointestinal surgery, or active gallstone disease
* Active treatment for cancer in the past year
* Taking medications that preclude fasting for 16 hours (e.g. must be taken with food at least 12 hours apart)
* Diagnosed cognitive impairment
* Unable to fast for 16 hours.
* Any condition that in the opinion of the investigator would impair ability to participate in the trial
Source: ClinicalTrials.gov (NCT07634926). StuddyBuddy aggregates publicly available trial information.