Early Time-Restricted Eating in Older Adults With Hypertension

NCT07135505 | Recruiting

• 2 other identifiers: IRB-300013053UAB NORC Pilot Grant
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension; Eating Behaviors

Outcome Measures

Primary Outcomes (3)

• Blood glucose

  measured by the continuous glucose monitor

  Baseline and 12 weeks

• Heart rate variability

  measured by the Holter monitor

  Baseline and 12 weeks

• Systolic Blood pressure

  measured by the ambulatory blood pressure monitor

  Baseline and 12 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Early time-restricted eating

Behavioral: Early time-restricted eating

Control

NO INTERVENTION

Interventions

Early time-restricted eating BEHAVIORAL

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

Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• UAB Nutrition Obesity Research Center: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Feeding Behavior

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior, Animal; Behavior

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: August 14, 2025
• First Posted: August 22, 2025
• Study Start: February 16, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)