Early Time-Restricted Eating in Older Adults With Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Alabama at Birmingham
About this trial
The purpose of this study is to find out how early time-restricted eating affects body rhythms and improves cardiometabolic health in older adults.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Early time-restricted eating
BehavioralThe 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: InterventionActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Blood glucose
measured by the continuous glucose monitor
Time frame
Baseline and 12 weeks2
Heart rate variability
measured by the Holter monitor
Time frame
Baseline and 12 weeks3
Systolic Blood pressure
measured by the ambulatory blood pressure monitor
Time frame
Baseline and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
UAB Nutrition Obesity Research Center
Collaborator
Source ClinicalTrials.gov