Early Time-Restricted Eating in Older Adults With Hypertension

NCT ID: NCT07135505

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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Conditions

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Hypertension Eating Behaviors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Early time-restricted eating

Group Type ACTIVE_COMPARATOR

Early time-restricted eating

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UAB Nutrition Obesity Research Center

UNKNOWN

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Yi Lin

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Facility Contacts

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Yi Lin, PhD

Role: primary

Other Identifiers

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UAB NORC Pilot Grant

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300013053

Identifier Type: -

Identifier Source: org_study_id