Health TrialsbyHealthPanel

Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health

ConditionsMetabolic SyndromePre-diabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of California, San Diego

About this trial

In a randomized controlled trial, the investigators intend to measure the health impact of time restricted eating (TRE) in patients with metabolic syndrome (with elevated blood pressure and at least 2 of the following: increased waist circumference, abnormal cholesterol levels, elevated triglycerides, and elevated fasting glucose levels), who habitually eat more than 12 hours every day. Patients will be randomly assigned to a control group (standard of care) or intervention group (TRE).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18-75 years

HbA1c: 5.7% to 7.0%

Elevated systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg OR an antihypertensive therapy)

Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides d) Reduced High-density lipoprotein (HDL)- cholesterol < 40 mg/dL in males or < 50 mg//dL in females, or drug treatment for reduced HDL-cholesterol e) Fasting glucose ≥ 100 mg/dL

Disqualifiers

Use of sulfonylurea or insulin.

HbA1C > 7.0%

Pregnant or breastfeeding. Anyone of reproductive age will receive pregnancy test prior to DXA scan.

Caregiver for a dependent requiring frequent nocturnal care / sleep interruptions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time-restricted eating (TRE) + Standard of Care

    Behavioral

    Participants in this arm will adhere to a daily, consistent 10-hour eating window for the course of the study as well as receive nutritional counseling from the study dietician.

  • Standard of Care

    Behavioral

    Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt the 10-hour eating window.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Time-restricted eating (TRE)Experimental treatment 1 intervention
Group B: Standard of care (SOC)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Glucose Levels

Assessed via HbA1c (%)

Time frame
54 weeks

Secondary outcomes

1

Change in glycemic variability

Measured by continuous glucose monitor (CGM)

Time frame
54 weeks
2

Change in direct LDL-C

LDL cholesterol (mg/dl)

Time frame
54 weeks
3

Change in bone density

Bone density measured by DEXA scan (g/cm\^2)

Time frame
54 weeks
4

Change in insulin sensitivity

Measured by oral glucose tolerance test (OGTT)

Time frame
54 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

Salk Institute for Biological Studies

Collaborator

Source ClinicalTrials.gov
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