NCT07135505 · University of Alabama at Birmingham
Early Time-Restricted Eating in Older Adults With Hypertension
What this study is about
The purpose of this study is to find out how early time-restricted eating affects body rhythms and improves cardiometabolic health in older adults.
View original scientific description
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
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.
Primary outcome measures
Blood glucose
Time frame: Baseline and 12 weeks
measured by the continuous glucose monitor
Heart rate variability
Time frame: Baseline and 12 weeks
measured by the Holter monitor
Systolic Blood pressure
Time frame: Baseline and 12 weeks
measured by the ambulatory blood pressure monitor
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Birmingham, Alabama
Collaborators
UAB Nutrition Obesity Research Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations