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

NCT03182985 | Completed

• 1 other identifier: UCSD IRB 170504
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean blood glucose

  Measured using a continuous glucose monitoring (CGM) device

  12 weeks

Secondary Outcomes (1)

• Insulin, triglycerides, hs-CRP levels

  12 weeks

Study Arms (1)

Time Restricted Feeding

EXPERIMENTAL

Patients will reduce daily oral intake to 10 hours per day

Behavioral: Time Restricted Feeding

Interventions

Time Restricted Feeding 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.

Time Restricted Feeding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Waist circumference ≥ 102 cm (Men) or ≥ 88 cm (Women).
• Triglycerides ≥ 150 mg/dL (or on drug treatment for elevated triglycerides).
• Reduced HDL-C \< 40 mg/dL (Men), \< 50 mg/dL (Women) (or on drug treatment for reduced HDL-C).
• Elevated blood pressure, systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg (or treatment with antihypertensive drug with history of hypertension).
• Elevated fasting glucose ≥ 100 mg/dL (or drug treatment of elevated blood glucose).
• Age ≥18 years.
• 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
• Own a Smartphone with Apple iOperating System (OS) or Android OS. Baseline eating period is ≥ 14 hours per day.

You may not qualify if:

• Pregnant or breast-feeding.
• Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. Shift workers with variable (e.g. nocturnal) hours.
• Planned international travel during the study period.
• Active tobacco abuse or history of treatment for alcohol abuse,
• Known inflammatory and/or rheumatologic disease,
• Known history of familial hypercholesterolemia,
• 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))
• History of sudden cardiac death (SCD) or implantable cardiac defibrillator (ICD) implantation for any reason,
• Known history of thyroid or adrenal disease,
• Any history of malignancy,
• Known history of type I diabetes,
• Known history of major immune disease,
• Eating disorder or bile syndrome,
• History of cirrhosis
• History of stage 4 or 5 chronic kidney disease or requiring dialysis

Sponsors & Collaborators

• University of California, San Diego: lead
• Salk Institute for Biological Studies: collaborator

Study Sites (1)

UCSD

La Jolla, California, 92037, United States

Location

Related 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.

  PMID: 25470547 BACKGROUND

• 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.

  PMID: 25766238 BACKGROUND

MeSH Terms

Conditions

Weight Loss; Metabolic Syndrome; Overweight; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders

Study Officials

• Pam Taub, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 9, 2017
• Study Start: July 28, 2017
• Primary Completion: January 31, 2019
• Study Completion: August 5, 2019
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)