The Impact of Time Restricted Feeding (TRF) in Improving the Health of Patients With Metabolic Syndrome

The investigators intend to measure the health impact of a dietary intervention known as time restricted feeding (TRF) on patients with metabolic syndrome (three or more of: increased waist circumference, abnormal cholesterol levels, elevated blood pressure, or elevated blood sugar). The investigators will enroll patients with metabolic syndrome who eat for ≥ 14 hours per day and will ask participants to reduce daily oral intake to 10 hours per day. The investigators will assess the impact of this dietary change using measures obtained before and after a 12 week intervention period, including body mass index, blood pressure, various lab parameters and blood sugar levels (assessed using a continuous glucose monitor). The investigators will assess for compliance with TRF using a Smart Phone application (myCircadianClock (mCC) app).

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Weight Loss; Overweight and Obesity
• Intervention / Treatment: Behavioral: Time Restricted Feeding

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • UCSD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Waist circumference ≥ 102 cm (Men) or ≥ 88 cm (Women).
2. Triglycerides ≥ 150 mg/dL (or on drug treatment for elevated triglycerides).
3. Reduced HDL-C < 40 mg/dL (Men), < 50 mg/dL (Women) (or on drug treatment for reduced HDL-C).
4. Elevated blood pressure, systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg (or treatment with antihypertensive drug with history of hypertension).
5. Elevated fasting glucose ≥ 100 mg/dL (or drug treatment of elevated blood glucose).
6. Age ≥18 years.
7. If patients are on cardiovascular medications (HMG coenzyme A reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs), no dose adjustments will be allowed during the study period
8. Own a Smartphone with Apple iOperating System (OS) or Android OS. Baseline eating period is ≥ 14 hours per day.

Exclusion Criteria:

1. Pregnant or breast-feeding.
2. Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. Shift workers with variable (e.g. nocturnal) hours.
3. Planned international travel during the study period.
4. Active tobacco abuse or history of treatment for alcohol abuse,
5. Known inflammatory and/or rheumatologic disease,
6. Known history of familial hypercholesterolemia,
7. History of major adverse cardiovascular event within the past 1 year (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack (TIA))
8. Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria)
9. History of sudden cardiac death (SCD) or implantable cardiac defibrillator (ICD) implantation for any reason,
10. Known history of thyroid or adrenal disease,
11. Any history of malignancy,
12. Known history of type I diabetes,
13. Known history of major immune disease,
14. Eating disorder or bile syndrome,
15. History of cirrhosis
16. History of stage 4 or 5 chronic kidney disease or requiring dialysis
17. History of chronic obstructive pulmonary disease (COPD)
18. Known active infectious diseases,
19. Currently enrolled in a weight-loss or weight-management program,
20. On a special or prescribed diet for other reasons (e.g. Celiac disease),
21. Currently taking any medication that is meant for, or has known effect on, appetite,
22. Any history of surgical intervention for weight management,
23. History of venous thromboembolism.
24. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness)
25. History of known clotting or bleeding disorder(s)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time Restricted Feeding; Patients will reduce daily oral intake to 10 hours per day	Behavioral: Time Restricted Feeding; Participants will reduce the amount of time they eat to 10 hours per day and will log their dietary intake using a smartphone application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean blood glucose	Measured using a continuous glucose monitoring (CGM) device	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin, triglycerides, hs-CRP levels	Measured by blood test	12 weeks

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Salk Institute for Biological Studies

Publications and helpful links

General Publications

• Chaix A, Zarrinpar A, Miu P, Panda S. Time-restricted feeding is a preventative and therapeutic intervention against diverse nutritional challenges. Cell Metab. 2014 Dec 2;20(6):991-1005. doi: 10.1016/j.cmet.2014.11.001.
• Gill S, Le HD, Melkani GC, Panda S. Time-restricted feeding attenuates age-related cardiac decline in Drosophila. Science. 2015 Mar 13;347(6227):1265-9. doi: 10.1126/science.1256682.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): August 5, 2019

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Body Weight; Insulin Resistance; Hyperinsulinism; Body Weight Changes; Syndrome; Metabolic Syndrome; Weight Loss; Overweight
• Other Study ID Numbers: UCSD IRB 170504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No