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
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 trial will explore whether consuming all meals earlier in the day, within an 8-hour window, can improve heart and blood vessel health in older adults with high blood pressure. Participants will either follow this early time-restricted eating (eTRE) schedule or maintain their usual eating habits for 12 weeks. Researchers aim to determine if meal timing can lower blood pressure and enhance overall heart health. The trial suits individuals who are 60 or older, have high blood pressure, and often skip breakfast. As an unphased trial, it provides a unique opportunity to contribute to innovative research on meal timing and heart health.

What prior data suggests that early time-restricted eating is safe for improving heart and blood vessel health?

Research shows that early time-restricted eating (eTRE) is generally safe. Studies have found that eating within a specific time frame each day can improve health markers like blood sugar levels and blood pressure, which are important for heart health.

However, some studies have noted potential risks. For example, one report mentioned a higher risk of heart issues when eating is limited to less than eight hours a day. Despite this, many participants in eTRE studies did not experience significant negative effects.

This trial is not testing a new drug but rather a change in eating habits. The goal is to determine if this eating schedule is safe and beneficial. Overall, evidence suggests that eTRE is safe, but consulting a healthcare provider is advisable if there are any concerns.12345

Why are researchers excited about this trial?

Unlike standard treatments for high blood pressure that often rely on medications like ACE inhibitors, beta-blockers, or diuretics, early time-restricted eating (eTRE) offers a lifestyle-based approach. eTRE is unique because it involves eating only within an 8-hour window each day, which may help regulate blood pressure by aligning eating patterns with the body's natural circadian rhythms. Researchers are excited about eTRE because it might provide a non-pharmaceutical option for managing high blood pressure, potentially reducing reliance on medications and minimizing side effects. Additionally, this method could encourage healthier eating habits and improve overall metabolic health.

What evidence suggests that early time-restricted eating is effective for high blood pressure?

Research has shown that eating all meals within a 10-hour window each day, known as early time-restricted eating (eTRE), can help lower blood pressure. One study found that people who followed this eating pattern lost weight and had lower blood pressure. Another study discovered that eTRE reduced systolic blood pressure and improved other health measures like blood sugar and insulin levels. eTRE works by calming the part of the nervous system that can raise blood pressure. These findings suggest that changing meal timing might improve heart health, especially for those with high blood pressure. Participants in this trial will join either the eTRE group, following a specific fasting schedule, or a control group maintaining their habitual eating patterns.56789

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+

Citations

Effect of early time-restricted feeding on the metabolic ...

M.J. Wilkinson et al. Ten-hour time-restricted eating reduces weight, blood pressure, and atherogenic lipids in patients with metabolic syndrome. Cell ...

Early versus late time‐restricted feeding in adults at ...

This study aims to compare the effects of early- versus late-TRF in a group of adults, who through self-assessment, are deemed to be at ...

(PDF) Intermittent Fasting and Blood Pressure Reduction

Lastly, IF lowers blood pressure through complex and multifactorial mechanisms. These include a decrease in sympathetic nervous system activity and an ...

Sarah Salvy | Publications

This randomized trial compared time-restricted eating (TRE) with eating over a period of 12 or more hours while matching weight-loss counseling across groups.

Is time-restricted eating more effective than calorie ...

In this year-long randomized controlled study, time-restricted eating was as effective as intentional calorie restriction for weight loss, ...

Time-restricted eating may not improve cardiometabolic ...

Time-restricted eating was not associated with improvements in any of 6 cardiometabolic measures — including abdominal obesity, metabolic ...

(PDF) Effects of time-restricted eating with different ...

blood pressure (systolic and diastolic), Meta-analysis of the effects of time-restricted eating vs comparator on systolic blood pressure.

Time Restricted Eating Research Unveiled at AHA ...

A preliminary research abstract reported a 91% higher risk of cardiovascular death for those who restricted their eating across fewer than eight ...

8-hour time-restricted eating linked to a 91% higher risk of ...

8-hour time-restricted eating linked to a 91% higher risk of cardiovascular death?! Time Restricted Eating/Intermittent Fasting is AMAZING for ...