Early Time-Restricted Eating for Cardiovascular Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Alabama at Birmingham
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Early Time-Restricted Eating (eTRE)
BehavioralParticipants 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Early time-restricted eating (eTRE) groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline (Week 0), Week 6, and Week 12 of the interventionSecondary outcomes
1
Flow-Mediated Dilation
Change in endothelial function assessed by brachial artery flow-mediated dilation (FMD) using ultrasound. FMD will be expressed as the change in brachial artery diameter following reactive hyperemia.
Time frame
Baseline (Week 0), Week 6, and Week 12 of the interventionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: