Early Time-Restricted Eating in Older Adults With Hypertension

The University of Alabama at Birmingham

Status: Begins enrollment this month

Conditions: Hypertension; Eating Behaviors

Treatments: Behavioral: Early time-restricted eating

Study type: Interventional

Funder types: Other

Identifiers

NCT07135505

IRB-300013053

UAB NORC Pilot Grant (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to find out how early time-restricted eating affects body rhythms and improves cardiometabolic health in older adults.

Enrollment: 30 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consent to participate in the study
• Men and women ≥ 60 years old
• Average office systolic BP ≥130 mmHg
• Self-reported ≥12 hours eating period per day of at least 5 days/week
• Stable health history over the past 2 months

Exclusion criteria

• Fasting >12 hours per day
• Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake
• Have lost ≥ 10 pounds in last 3 months
• Unable to wake up at a regular time between 6-8 am
• Perform overnight shift work more than 1day/week on average
• Resting heart rate of >120 beats per minute, systolic blood pressure > 180 mmHg and/or diastolic blood pressure of > 100 mmHg
• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Intervention

Active Comparator group

Description:

Early time-restricted eating

Treatment:

Behavioral: Early time-restricted eating

Control

No Intervention group