Time for better time-restricted eating trials to lessen the burden of metabolic diseases.
Pam R Taub, Satchidananda Panda
https://pubmed.ncbi.nlm.nih.gov/35732151Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID07189234
TIMET 2.0 - Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health
Led by University of California, San Diego · Updated on 2026-02-02
140
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
S
Salk Institute for Biological Studies
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of time-restricted eating (TRE) on patients with metabolic syndrome who have high blood pressure and at least two other metabolic risk factors, such as increased waist size, abnormal cholesterol, high triglycerides, or elevated fasting glucose. The study focuses on people who typically eat for more than 12 hours daily and aims to better understand how limiting eating to a 10-hour window daily may impact cardiometabolic health over a long period. Participants are randomly assigned to one of two groups: one follows a daily 10-hour eating window combined with standard care and nutritional counseling, while the other continues their usual lifestyle without the eating window but also receives nutritional counseling. The study lasts 54 weeks and involves logging all food and drink intake using a smartphone app. Both groups receive lifestyle coaching and track their calories using the app. Throughout the study, researchers will measure height, weight, waist size, and blood pressure. Blood tests will check blood sugar control, insulin, lipids, and detailed cholesterol profiles. Participants will wear a continuous glucose monitor and an activity tracker at the start, six months, and the end of the study to monitor blood sugar, physical activity, and sleep. Body composition will be evaluated by DEXA scans, and an oral glucose tolerance test will assess how the body handles sugar. The main outcome is change in glucose levels after 54 weeks, along with other measures like cholesterol, insulin sensitivity, bone density, muscle mass, and body fat.
CONDITIONS
Brief Title
Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- HbA1c between 5.7% and 7.0%
- Diagnosis of metabolic syndrome meeting at least three criteria: elevated blood pressure (≥130/85 mm Hg or on antihypertensive therapy), increased waist circumference (≥90 cm men/≥80 cm women for Asians; ≥102 cm men/≥88 cm women for others), fasting triglycerides ≥150 mg/dL or treatment for elevated triglycerides, reduced HDL-cholesterol (<40 mg/dL men, <50 mg/dL women) or treatment for reduced HDL, fasting glucose ≥100 mg/dL
- Own a smartphone with Apple iOS or Android operating system
- Baseline daily eating period of 12 hours or more
- Stable dose of cardiovascular medications (e.g., statins, lipid-modifying drugs, antihypertensives) for at least 1 month
- Stable doses of GLP-1 receptor agonists, SGLT2 inhibitors, or Metformin for at least 3 months
You will not qualify if you...
- Use of sulfonylurea or insulin
- HbA1c greater than 7.0%
- Pregnancy or breastfeeding; pregnancy test required for those of reproductive age before DEXA scan
- Caregivers requiring frequent nocturnal care or sleep interruptions
- Shift workers with variable or night shifts
- Frequent travel across time zones during the study
- Active tobacco use, illicit drug use, or history of treatment for alcohol abuse
- Major cardiovascular event within the past year (e.g., heart attack, stroke, heart surgery, heart failure hospitalization)
- Weight management surgery within the past 2 years or longer if unsafe
- Uncontrolled arrhythmia (rate-controlled atrial fibrillation/flutter allowed)
- Recent thyroid disease requiring medication dose changes
- History of adrenal disease
- Active cancer treatment except non-melanoma skin cancer
- Known type 1 diabetes
- History of eating disorder
- History of cirrhosis
- Advanced kidney disease stage 4 or 5 or dialysis
- Currently enrolled in a weight-loss program
- Following a special or prescribed diet (e.g., Celiac disease)
- Uncontrolled psychiatric disorder or hospitalization for psychiatric illness
- Unable or unwilling to use the smartphone app throughout the study duration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 54 weeks
Participants follow a behavioral intervention where they either adhere to a daily, consistent 10-hour eating window with nutritional counseling or maintain their current lifestyle with nutritional counseling and track caloric intake using a smartphone app. They use the app throughout the study to log all food and beverage intake.
Regular meetings with a dietician and periodic assessments including blood tests, body measurements, and device wear at baseline, 6 months, and 12 months
Follow-up
Duration - Up to 12 months total from study start
Participants continue to be monitored for changes in cardiometabolic health parameters after the active intervention period.
Device-based monitoring with continuous glucose monitors and actigraphy devices worn for 2 weeks at baseline, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92093
Actively Recruiting
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Research Team
G
Gavin McLaren
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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