Recruiting NCT07135505
Early Time-Restricted Eating in Older Adults With Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early time-restricted eating.
- Who it may be relevant to
- Registry conditions: Hypertension, Eating Behaviors. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Early Time-Restricted Eating on Cardiometabolic Health and Circadian Rhythms in Hypertensive Older Adults With Habitual Prolonged Eating Window
Overview
The purpose of this study is to find out how early time-restricted eating affects body rhythms and improves cardiometabolic health in older adults.
Interventions
- Behavioral 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 measures
- 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]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT07135505 · IRB-300013053 · UAB NORC Pilot Grant