Metabolic Syndrome, Overweight and Obesity, Weight Loss
Conditions
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).
Interventions
BEHAVIORALTime 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.
Sponsors
Salk Institute for Biological Studies
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean blood glucose | 12 weeks | Measured using a continuous glucose monitoring (CGM) device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin, triglycerides, hs-CRP levels | 12 weeks | Measured by blood test |
Countries
United States
Outcome results
None listed