Early Time-Restricted Eating for Cardiovascular Health

NCT07634926 | Not Yet Recruiting

• 2 other identifiers: IRB-30001610526CDA1600914
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Breakfast Skipper

Keywords

Early Time-Restricted Eating; Circadian Rhythm; Hypertension; Breakfast Skipping; Cardiovascular Health

Outcome Measures

Primary Outcomes (1)

• 24-Hour Systolic Blood Pressure

  Change in mean 24-hour systolic blood pressure measured using ambulatory blood pressure monitoring (ABPM). Blood pressure will be recorded over a 24-hour period to assess the effects of early time-restricted eating on blood pressure regulation.

  Baseline (Week 0), Week 6, and Week 12 of the intervention

Secondary Outcomes (1)

• Flow-Mediated Dilation

  Baseline (Week 0), Week 6, and Week 12 of the intervention

Study Arms (2)

Early time-restricted eating (eTRE) group

EXPERIMENTAL

Participants in the eTRE group will be asked to fast for a target of 16 hours per day (eat ad libitum within the 8-hour eating window, starting between 6:30-9:30 am), 6 days/week for 12 weeks.

Behavioral: Early Time-Restricted Eating (eTRE)

Control group

NO INTERVENTION

Participants in the control group will be instructed to maintain habitual eating patterns.

Interventions

Early Time-Restricted Eating (eTRE) BEHAVIORAL

Participants in the eTRE group will be asked to fast for a target of 16 hours per day (eat ad libitum within the 8-hour eating window, starting between 6:30-9:30 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.

Early time-restricted eating (eTRE) group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Hypertension; Intermittent Fasting

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Fasting; Feeding Behavior; Behavior

Central Study Contacts

Yi Lin, PhD

CONTACT

205.996.5876; yilin@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting Date Available: 09/01/2029 Ending Date Available: 08/31/2034
• Access Criteria: De-identified data will be available to qualified researchers whose proposed use of the data has been approved by the study investigators. Access will be provided for research purposes that are consistent with the informed consent provided by study participants. Researchers may request access by contacting the Principal Investigator and may be required to sign a data use agreement prior to receiving the data. Data will be shared electronically through secure file transfer methods.

Locations

US (1)