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

NCT ID: NCT03182985

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-28
• Study Completion Date: 2019-08-05

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).

Conditions

Weight Loss; Metabolic Syndrome; Overweight and Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Time Restricted Feeding

Patients will reduce daily oral intake to 10 hours per day

Group Type: EXPERIMENTAL

Time Restricted Feeding

Intervention Type: BEHAVIORAL

Participants will reduce the amount of time they eat to 10 hours per day and will log their dietary intake using a smartphone application.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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))

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Salk Institute for Biological Studies

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Pam Taub, MD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pam Taub, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

UCSD

La Jolla, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25470547 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25766238 (View on PubMed)

Other Identifiers

UCSD IRB 170504

Identifier Type: -

Identifier Source: org_study_id