The Impact of Time Restricted Feeding (TRF) in Improving the Health of Patients With Metabolic Syndrome
Primary Purpose
Weight Loss, Metabolic Syndrome, Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time Restricted Feeding
Sponsored by
About this trial
This is an interventional prevention trial for Weight Loss
Eligibility Criteria
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)
Sites / Locations
- UCSD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Time Restricted Feeding
Arm Description
Patients will reduce daily oral intake to 10 hours per day
Outcomes
Primary Outcome Measures
Mean blood glucose
Measured using a continuous glucose monitoring (CGM) device
Secondary Outcome Measures
Insulin, triglycerides, hs-CRP levels
Measured by blood test
Full Information
NCT ID
NCT03182985
First Posted
June 5, 2017
Last Updated
January 7, 2021
Sponsor
University of California, San Diego
Collaborators
Salk Institute for Biological Studies
1. Study Identification
Unique Protocol Identification Number
NCT03182985
Brief Title
The Impact of Time Restricted Feeding (TRF) in Improving the Health of Patients With Metabolic Syndrome
Official Title
The Impact of Time Restricted Feeding (TRF) in Improving the Health of Patients With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 28, 2017 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
August 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Salk Institute for Biological Studies
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Metabolic Syndrome, Overweight and Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Time Restricted Feeding
Arm Type
Experimental
Arm Description
Patients will reduce daily oral intake to 10 hours per day
Intervention Type
Behavioral
Intervention Name(s)
Time Restricted Feeding
Intervention Description
Participants will reduce the amount of time they eat to 10 hours per day and will log their dietary intake using a smartphone application.
Primary Outcome Measure Information:
Title
Mean blood glucose
Description
Measured using a continuous glucose monitoring (CGM) device
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Insulin, triglycerides, hs-CRP levels
Description
Measured by blood test
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pam Taub, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25470547
Citation
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.
Results Reference
background
PubMed Identifier
25766238
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.
Results Reference
background
Learn more about this trial
The Impact of Time Restricted Feeding (TRF) in Improving the Health of Patients With Metabolic Syndrome
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