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

• Sponsor: University of California, San Diego
• Collaborator: Salk Institute for Biological Studies
• Information provided by (Responsible Party): Pam Taub, MD, University of California, San Diego

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Weight Loss; Metabolic Syndrome; Overweight and Obesity	Behavioral: Time Restricted Feeding	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	35 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	The Impact of Time Restricted Feeding (TRF) in Improving the Health of Patients With Metabolic Syndrome
Actual Study Start Date :	July 28, 2017
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	June 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Mean blood glucose [ Time Frame: 12 weeks ]
   Measured using a continuous glucose monitoring (CGM) device

Secondary Outcome Measures :

1. Insulin, triglycerides, hs-CRP levels [ Time Frame: 12 weeks ]
   Measured by blood test

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Locations

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

Sponsors and Collaborators

University of California, San Diego

Salk Institute for Biological Studies

Investigators

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Principal Investigator:	Pam Taub, MD	UCSD

More Information

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.

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Responsible Party:	Pam Taub, MD, Associate Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier:	NCT03182985 History of Changes
Other Study ID Numbers:	UCSD IRB 170504
First Posted:	June 9, 2017
Last Update Posted:	October 24, 2018
Last Verified:	October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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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

Additional relevant MeSH terms:

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Syndrome; Overweight; Weight Loss; Metabolic Syndrome; Disease; Pathologic Processes; Body Weight	Signs and Symptoms; Body Weight Changes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases