Search > Hypertension
My employer runs this trial

Early Time-Restricted Eating for High Blood Pressure

(ALIGN Trial)

YL
Overseen ByYi Lin, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
Must not be taking: Insulin, Diabetes medication
Disqualifiers: Diabetes, Unstable angina, Cancer, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for older adults with high blood pressure who often skip breakfast. Participants should not have other major health issues that would prevent them from safely following a specific eating schedule.

Inclusion Criteria

Self-reported skipping breakfast for at least 3 days in the past 7 days
Average office systolic BP ≥130 mmHg
Willing and able to provide informed consent
See 4 more

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
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow an early time-restricted eating schedule or continue their usual eating habits for 12 weeks

12 weeks
Baseline, Week 6, and Week 12 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Early Time-Restricted Eating (eTRE)

Trial Overview

The study tests if eating all meals within an early 8-hour window each day (early time-restricted eating) improves heart and blood vessel health compared to normal eating habits, over a period of 12 weeks. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Early time-restricted eating (eTRE) groupExperimental Treatment1 Intervention
Group II: Control groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.