The Influence of Time-Restricted Eating in Patients With Metabolic Syndrome

NCT04057339 | Unknown DMC

• 2 other identifiers: 1810881R01DK118278-01
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

In a randomized controlled trial, the investigators intend to measure the health impact of TRE in patients with metabolic syndrome (with three or more of the following criteria: increased waist circumference, abnormal cholesterol levels, elevated blood pressure, or elevated blood sugar), who habitually eat for more than 14 hours every day. Patients will be randomly assigned to a control group of behavioral nutrition counseling (standard of care) or the intervention group of behavioral nutrition counseling with the addition of adopting a 8-10 hour eating window for 12 weeks (TRE).

Conditions

Metabolic Syndrome; Pre-Diabetes

Keywords

Time Restricted Eating; Circadian Rhythm; Glucose Homeostasis; Mitochondrial Function; Fasting

Outcome Measures

Primary Outcomes (2)

• Change in glucose levels assessed via HbA1c

  HbA1c (%)

  Baseline and 14 weeks

• Change in glycemic parameters

  Glycemic parameters assessed via fasting glucose (mg/dL), HOMA-IR, Insulin (mIU/L), and continuous glucose monitors (CGM).

  Baseline and 14 weeks

Secondary Outcomes (6)

• Change in LDL particle number

  Baseline and 14 weeks

• Change in LDL cholesterol

  Baseline and 14 weeks

• Change in HDL cholesterol

  Baseline and 14 weeks

• Change in Triglycerides

  Baseline and 14 weeks

• Change in body composition by DXA

  Baseline and 14 weeks

Other Outcomes (1)

• Change in mitochondrial structure and gene expression in skeletal muscle

  Baseline and 14 weeks

Study Arms (2)

SOC (Standard of Care)

PLACEBO COMPARATOR

Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.

Behavioral: Standard of Care

TRE + SOC

EXPERIMENTAL

Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.

Behavioral: Time Restricted Eating + Standard of Care

Interventions

Time Restricted Eating + Standard of Care BEHAVIORAL

Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.

Also known as: Time Restricted Eating

TRE + SOC

Standard of Care BEHAVIORAL

Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window.

SOC (Standard of Care)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• ≥ BMI ≥ 25 AND
• Metabolic syndrome, as defined as presence of 3 or more of the following criteria:
• Elevated fasting plasma glucose ≥ 100 mg/dL and/or HbA1c ≥ 5.7% \< 7.1% Elevated waist circumference: In Asians: ≥ 90 cm in men, ≥ 80 cm in women, all other races: ≥ 102 cm in men, ≥ 88 cm in women Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides Reduced High-density lipoprotein (HDL)-cholesterol \< 40 mg/dL in males or \< 50 mg/dL in females, or drug treatment for reduced HDL-cholesterol Elevated blood pressure, Systolic blood pressure ≥ 135 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg or drug treatment for hypertension
• Own a smartphone (Apple iOS or Android OS)
• Baseline eating period ≥ 12 hour window
• If patients are on cardiovascular medications (HMG CoA 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.

You may not qualify if:

• Taking insulin within the last 6 months.
• Manifest diabetes, defined as HbA1c \> 7.0% given a 0.3% margin of error in lab readings, or diagnosis of diabetes.
• Known inflammatory and/or rheumatologic disease.
• Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse.
• Pregnant or breast-feeding women.
• Shift workers with variable (e.g. nocturnal) hours.
• Caregivers for dependent requiring frequent nocturnal care/sleep interruptions.
• Planned travel to a time zone with greater than a 3-hour difference during study period.
• 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 adrenal disease.
• History of malignancy undergoing active treatment, except non-melanoma skin cancer.
• Known history of type I diabetes.
• History of eating disorder(s).
• History of cirrhosis.
• History of stage 4 or 5 chronic kidney disease or requiring dialysis.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Salk Institute for Biological Studies: collaborator

Study Sites (1)

Altman Clinical and Translational Research Institute

La Jolla, California, 92093, United States

Location

Related Publications (2)

• Manoogian ENC, Wilkinson MJ, O'Neal M, Laing K, Nguyen J, Van D, Rosander A, Pazargadi A, Gutierrez NR, Fleischer JG, Golshan S, Panda S, Taub PR. Time-Restricted Eating in Adults With Metabolic Syndrome : A Randomized Controlled Trial. Ann Intern Med. 2024 Nov;177(11):1462-1470. doi: 10.7326/M24-0859. Epub 2024 Oct 1.

  PMID: 39348690 DERIVED

• Taub PR, Panda S. Time for better time-restricted eating trials to lessen the burden of metabolic diseases. Cell Rep Med. 2022 Jun 21;3(6):100665. doi: 10.1016/j.xcrm.2022.100665.

  PMID: 35732151 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Glucose Intolerance; Intermittent Fasting; Fasting

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Pam Taub, MD

  Associate Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: August 15, 2019
• Study Start: April 8, 2019
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

US (1)