Recruiting

Time-Restricted Eating

Sponsor:

University of Alabama at Birmingham

Code:

NCT07135505

Conditions

Hypertension

Eating Behaviors

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Early time-restricted eating

Study Details

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

Study ID

NCT07135505

Start date

Feb 16, 2026

Status verified date

Jun, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention

Early time-restricted eating

no intervention: Control

Interventions

Early time-restricted eating

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.

Primary outcome measure

  • Blood glucose [ Time Frame: Baseline and 12 weeks ]
  • Heart rate variability [ Time Frame: Baseline and 12 weeks ]
  • Systolic Blood pressure [ Time Frame: Baseline and 12 weeks ]

Central Contacts and Locations

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Yi Lin, PhD

205-996-5876yilin@uabmc.edu

Principal Investigator:

Yi Lin, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-22.