RECRUITING

Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health

Conditions

Metabolic Syndrome Pre-diabetes Time Restricted Eating Fasting

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In a randomized controlled trial, the investigators intend to measure the health impact of time restricted eating (TRE) in patients with metabolic syndrome (with elevated blood pressure and at least 2 of the following: increased waist circumference, abnormal cholesterol levels, elevated triglycerides, and elevated fasting glucose levels), who habitually eat more than 12 hours every day. Patients will be randomly assigned to a control group (standard of care) or intervention group (TRE).

Official Title

TIMET 2.0 - Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health

Quick Facts

Study Start:2025-09-22

Study Completion:2031-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07189234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age: 18-75 years 2. HbA1c: 5.7% to 7.0% 3. Metabolic syndrome (must meet 3 criteria): Elevated systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg (required) and 2 of the following: * Elevated waist circumference: * In Asians: ≥ 90 cm in men, ≥80 cm in women * In all other races: ≥ 102 cm in men, ≥ 88 cm in women * Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides * Reduced High-density lipoprotein (HDL)- cholesterol \< 40 mg/dL in males or \< 50 mg/dL in females, or drug treatment for reduced HDL-cholesterol * Fasting glucose ≥ 100 mg/dL 4. Own a smartphone (Apple iOS or Android OS) 5. Baseline eating period ≥12 hour/day 6. Patients on a stable dose of cardiovascular medications (HMG CoA reductase inhibitors (statins), metformin, other lipid-modifying drugs (including over-the-counter drugs such as red yeast rice and fish oil), anti-hypertensive drugs, GLP-1R agonists and SGLT2 inhibitors) for at least 3 months are allowed.	1. Use of sulfonylurea or insulin. 2. HbA1C \> 7.0% 3. Pregnant or breastfeeding. Anyone of reproductive age will receive pregnancy test prior to DXA scan. 4. Caregiver for a dependent requiring frequent nocturnal care / sleep interruptions. 5. Shift workers with variable (e.g. nocturnal) hours. 6. Frequent travel to different time zones during the study period. 7. Active tobacco use or illicit drug use or history of treatment for alcohol abuse. 8. History of major adverse cardiovascular event within the past year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack). 9. Uncontrolled arrhythmia (i.e. rate -controlled atrial fibrillation / atrial flutter are not exclusion criteria) 10. History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion). 11. History of adrenal disease. 12. History of malignancy undergoing active treatment, except non-melanoma skin cancer. 13. Known history of type 1 diabetes. 14. History of an eating disorder. 15. History of cirrhosis. 16. History of stage 4 or 5 chronic kidney disease or requiring dialysis. 17. Currently enrolled in a weight-loss or weight-management program. 18. On a special or prescribed diet for other reasons (e.g. Celiac disease). 19. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).

Inclusion Criteria

Exclusion Criteria

1. Age: 18-75 years
2. HbA1c: 5.7% to 7.0%
3. Metabolic syndrome (must meet 3 criteria): Elevated systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg (required) and 2 of the following:
* Elevated waist circumference:
* In Asians: ≥ 90 cm in men, ≥80 cm in women
* In all other races: ≥ 102 cm in men, ≥ 88 cm in women
* Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides
* Reduced High-density lipoprotein (HDL)- cholesterol \< 40 mg/dL in males or \< 50 mg/dL in females, or drug treatment for reduced HDL-cholesterol
* Fasting glucose ≥ 100 mg/dL
4. Own a smartphone (Apple iOS or Android OS)
5. Baseline eating period ≥12 hour/day
6. Patients on a stable dose of cardiovascular medications (HMG CoA reductase inhibitors (statins), metformin, other lipid-modifying drugs (including over-the-counter drugs such as red yeast rice and fish oil), anti-hypertensive drugs, GLP-1R agonists and SGLT2 inhibitors) for at least 3 months are allowed.

1. Use of sulfonylurea or insulin.
2. HbA1C \> 7.0%
3. Pregnant or breastfeeding. Anyone of reproductive age will receive pregnancy test prior to DXA scan.
4. Caregiver for a dependent requiring frequent nocturnal care / sleep interruptions.
5. Shift workers with variable (e.g. nocturnal) hours.
6. Frequent travel to different time zones during the study period.
7. Active tobacco use or illicit drug use or history of treatment for alcohol abuse.
8. History of major adverse cardiovascular event within the past year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack).
9. Uncontrolled arrhythmia (i.e. rate -controlled atrial fibrillation / atrial flutter are not exclusion criteria)
10. History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).
11. History of adrenal disease.
12. History of malignancy undergoing active treatment, except non-melanoma skin cancer.
13. Known history of type 1 diabetes.
14. History of an eating disorder.
15. History of cirrhosis.
16. History of stage 4 or 5 chronic kidney disease or requiring dialysis.
17. Currently enrolled in a weight-loss or weight-management program.
18. On a special or prescribed diet for other reasons (e.g. Celiac disease).
19. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).

Contacts and Locations

Study Contact

Gavin McLaren

CONTACT

(858) 246-2342

preventivecvresearch@health.ucsd.edu

Principal Investigator

Pam Taub, MD

PRINCIPAL_INVESTIGATOR

UC San Diego Health

Study Locations (Sites)

Altman Clinical and Translational Research Institute

La Jolla, California, 92093

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Pam Taub, MD, PRINCIPAL_INVESTIGATOR, UC San Diego Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-22

Study Completion Date2031-10-01

Study Record Updates

Study Start Date2025-09-22

Study Completion Date2031-10-01

Terms related to this study

Keywords Provided by Researchers

Time Restricted Eating
Fasting

Additional Relevant MeSH Terms

Metabolic Syndrome
Pre-diabetes