Early Time-Restricted Eating for Cardiovascular Health
Aligning Clocks: Time-Restricted Eating to Improve Cardiovascular Health in Hypertensive Older Adults Who Skip Breakfast
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 60 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 weeks
- Procedures mentioned: Questionnaires, Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be randomly assigned to either follow an early time-restricted eating schedule or continue their usual eating habits for 12 weeks."
- "Thirty-six adults aged 60 and older with breakfast-skipping behavior and hypertension (average daytime systolic BP ≥130 mmHg per AHA criteria) will be randomized to eTRE or control, with equal numbers of morning and evening chronotypes based on the Morningness-Eveningness Questionnaire."
- "Fasting blood samples will be collected to measure circadian clock gene expression and redox biomarkers."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether eating earlier in the day within the same 8-hour window can improve heart and blood vessel health. It is for adults age 60 or older with high blood pressure who often skip breakfast. For 12 weeks, participants will be assigned by chance to follow the early eating schedule or keep their usual eating habits.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 60 or older.
- Average top blood pressure number of at least 130 at an office visit.
- Skipped breakfast on at least 3 of the past 7 days.
- A study survey shows you are a morning person or an evening person.
- Your health has been stable for the past 2 months.
- Your medicines have been stable for the past 2 months, as advised by your main care provider.
- Willing and able to understand the study and agree to join.
Who can't join
- Already go without food for more than 13 hours a day; cannot go without food for 16 hours; or take medicines that prevent a 16-hour fast.
- Are in a weight-loss program, greatly limit calories to lose weight, or have lost at least 10 pounds in the past 3 months.
- Exercise more than 90 minutes a week, cannot wake at a regular time between 6 and 9 a.m., or work overnight more than 1 day a week on average.
- Resting heart rate above 120 beats a minute, top blood pressure number above 180, or bottom number above 100.
- Have diabetes or take insulin or other diabetes medicine; are pregnant or breastfeeding; or received cancer treatment in the past year.
- Had unstable angina (new or worsening chest pain), a heart attack, or a stroke in the past 3 months; or need oxygen all the time for lung disease or heart failure.
- Have rheumatoid arthritis (a disease that inflames joints), Parkinson's disease, dialysis treatment to filter your blood, severe digestive disease, major digestive surgery, or active gallstone disease.
- Have diagnosed problems with memory or thinking, a major mental health condition that limits participation, or any other condition the study doctor thinks would make participation difficult.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
AL
- University of Alabama at Birmingham · Birmingham, AL 35205Yi Lin, PhD · Study contact · 205.996.5876 · yilin@uabmc.eduMore trials in Birmingham