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



Status:Active, not recruiting
Conditions:Obesity Weight Loss, Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:10/26/2018
Start Date:July 28, 2017
End Date:June 2019

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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).


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)
We found this trial at
1
site
La Jolla, California 92093
Phone: 858-246-2510
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from
La Jolla, CA
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