RECRUITINGINTERVENTIONAL
Early Time-Restricted Eating in Older Adults With Hypertension
The Effect of Early Time-Restricted Eating on Cardiometabolic Health and Circadian Rhythms in Hypertensive Older Adults With Habitual Prolonged Eating Window
About This Trial
The purpose of this study is to find out how early time-restricted eating affects body rhythms and improves cardiometabolic health in older adults.
Who May Be Eligible (Plain English)
Who May Qualify:
- Consent to participate in the study
- Men and women ≥ 60 years old
- Average office systolic BP ≥130 mmHg
- Self-reported ≥12 hours eating period per day of at least 5 days/week
- Stable health history over the past 2 months
Who Should NOT Join This Trial:
- Fasting \>12 hours per day
- Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake
- Have lost ≥ 10 pounds in last 3 months
- Unable to wake up at a regular time between 6-8 am
- Perform overnight shift work more than 1day/week on average
- Resting heart rate of \>120 beats per minute, systolic blood pressure \> 180 mmHg and/or diastolic blood pressure of \> 100 mmHg
- 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)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Consent to participate in the study
* Men and women ≥ 60 years old
* Average office systolic BP ≥130 mmHg
* Self-reported ≥12 hours eating period per day of at least 5 days/week
* Stable health history over the past 2 months
Exclusion Criteria:
* Fasting \>12 hours per day
* Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake
* Have lost ≥ 10 pounds in last 3 months
* Unable to wake up at a regular time between 6-8 am
* Perform overnight shift work more than 1day/week on average
* Resting heart rate of \>120 beats per minute, systolic blood pressure \> 180 mmHg and/or diastolic blood pressure of \> 100 mmHg
* 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)
Treatments Being Tested
BEHAVIORAL
Early time-restricted eating
The participants will be asked to fast for a target of 16 hours per day (eat ad libitum within the 8-hour eating window, starting between 6:30-8:30 am), 6 days/week for 12 weeks. Participants will be allowed to consume calorie-free beverages, sugar-free gum, and will be encouraged to drink plenty of water throughout the entire intervention period.
Locations (1)
University of Alabama at Birmingham
Birmingham, Alabama, United States