The Impact of Time Restricted Feeding (TRF) in Improving the Health of Patients With Metabolic Syndrome
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03182985 |
Recruitment Status :
Completed
First Posted : June 9, 2017
Last Update Posted : January 11, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Weight Loss Metabolic Syndrome Overweight and Obesity | Behavioral: Time Restricted Feeding | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | The Impact of Time Restricted Feeding (TRF) in Improving the Health of Patients With Metabolic Syndrome |
Actual Study Start Date : | July 28, 2017 |
Actual Primary Completion Date : | January 31, 2019 |
Actual Study Completion Date : | August 5, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Time Restricted Feeding
Patients will reduce daily oral intake to 10 hours per day
|
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. |
- Mean blood glucose [ Time Frame: 12 weeks ]Measured using a continuous glucose monitoring (CGM) device
- Insulin, triglycerides, hs-CRP levels [ Time Frame: 12 weeks ]Measured by blood test

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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))
- Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria)
- 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
- History of chronic obstructive pulmonary disease (COPD)
- Known active infectious diseases,
- Currently enrolled in a weight-loss or weight-management program,
- On a special or prescribed diet for other reasons (e.g. Celiac disease),
- Currently taking any medication that is meant for, or has known effect on, appetite,
- Any history of surgical intervention for weight management,
- History of venous thromboembolism.
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness)
- History of known clotting or bleeding disorder(s)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182985
United States, California | |
UCSD | |
La Jolla, California, United States, 92037 |
Principal Investigator: | Pam Taub, MD | UCSD |
Responsible Party: | Pam Taub, MD, Associate Professor of Medicine, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT03182985 |
Other Study ID Numbers: |
UCSD IRB 170504 |
First Posted: | June 9, 2017 Key Record Dates |
Last Update Posted: | January 11, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Metabolic Syndrome Syndrome Overweight Weight Loss Disease Pathologic Processes |
Body Weight Body Weight Changes Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |