Eating Behaviors, Hypertension
Conditions
Brief summary
The purpose of this study is to find out how early time-restricted eating affects body rhythms and improves cardiometabolic health in older adults.
Interventions
BEHAVIORALEarly 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.
Sponsors
University of Alabama at Birmingham
UAB Nutrition Obesity Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose | Baseline and 12 weeks | measured by the continuous glucose monitor |
| Heart rate variability | Baseline and 12 weeks | measured by the Holter monitor |
| Systolic Blood pressure | Baseline and 12 weeks | measured by the ambulatory blood pressure monitor |
Countries
United States
Outcome results
None listed