Weight LossNCT03182985
The Impact of Time Restricted Feeding (TRF) in Improving the Health of Patients With Metabolic Syndrome
A study testing Time Restricted Feeding in people with Weight Loss and Metabolic Syndrome, run by University of California, San Diego at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss, Metabolic Syndrome, Overweight and Obesity
- What is being tested?
- Time Restricted Feeding
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2017to 5 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 25Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Time Restricted Feeding
- Medical subject headings
- Weight Loss, Metabolic Syndrome, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted FeedingBehavioural
Participants will reduce the amount of time they eat to 10 hours per day and will log their dietary intake using a smartphone application.
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Feeding | Experimental | Patients will reduce daily oral intake to 10 hours per day Receives: Behavioral: Time Restricted Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood glucose
Measured using a continuous glucose monitoring (CGM) device
Measured: 12 weeks
Secondary outcomes (1)
Insulin, triglycerides, hs-CRP levels
Measured by blood test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start28 Jul 2017
- Primary completion31 Jan 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Salk Institute for Biological Studies
- Responsible party
- Principal investigator, Pam Taub, MD, University of California, San Diego
- Investigators
- Pam Taub, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182985
- Sponsor's protocol ID
- UCSD IRB 170504
- Status last verified
- Jan 2021
- First submitted
- 5 Jun 2017
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25470547Gill 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.
PubMed 25766238
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Time Restricted Feeding (TRF) in Improving the Health of Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03182985
- Acronym / sponsor ID
- UCSD IRB 170504
- Conditions
- Weight Loss, Metabolic Syndrome, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Salk Institute for Biological Studies
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Feeding | Experimental | Behavioral: Time Restricted FeedingPatients will reduce daily oral intake to 10 hours per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (25 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted FeedingParticipants will reduce the amount of time they eat to 10 hours per day and will log their dietary intake using a smartphone application. | Behavioural | Time Restricted Feeding |
Primary outcome
Mean blood glucose
Time frame: 12 weeks
Measured using a continuous glucose monitoring (CGM) device
1 secondary outcome
Insulin, triglycerides, hs-CRP levels
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Background: PubMed 25470547Chaix 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.
- Background: PubMed 25766238Gill 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pam Taub, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Feeding in people with Weight Loss and Metabolic Syndrome, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean blood glucose (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03182985, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.