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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182985
• Other study ID #: UCSD IRB 170504
• Status: Completed
• Phase: N/A
• Start date: July 28, 2017
• Est. completion date: August 5, 2019

Study information

• Verified date: January 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 5, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Metabolic Syndrome
• Overweight
• Overweight and Obesity
• Syndrome
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	UCSD	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Salk Institute for Biological Studies

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean blood glucose	Measured using a continuous glucose monitoring (CGM) device	12 weeks
Secondary	Insulin, triglycerides, hs-CRP levels	Measured by blood test	12 weeks