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Effect of Time-restricted Eating on Catecholamine-sensitivity of Adipose Tissue in Obese Adults

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care
Time Restricted Eating
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Key words provided by Michael Wilkinson, MD, University of California San Diego:, Catecholamine Sensitivity, Circadian Rhythm, Fasting, Obesity, Time Restricted Eating, Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: ≥ 18 years old
  2. BMI 30-50 kg/m2
  3. Own a smartphone with Apple iOS or Android OS
  4. Baseline eating window ≥ 14 hours/day
  5. 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 drugs, no dose adjustments will be allowed during the study period.

Exclusion Criteria:

  1. Taking insulin or anti-diabetic medications within the last 6 months.
  2. Manifest diabetes, defined as fasting glucose ≥ 126 mg/dL, HbA1c ≥ 6.5%, or diagnosis of diabetes.
  3. Currently taking any medication that is meant for, or has known effect on, appetite or body weight
  4. Pregnant or breast-feeding women.
  5. Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. Shift workers with variable (e.g. nocturnal) hours.
  6. Planned international travel (time zone changes) during study period.
  7. Taking therapeutic anticoagulation which might increase risk of bleeding from adipose tissue biopsy
  8. History of surgical intervention for weight loss.
  9. History of eating disorder
  10. Currently enrolled in a weight-loss or weight-management program
  11. On a special or prescribed diet for other reasons (e.g. Celiac disease)
  12. Known inflammatory and/or rheumatologic disease
  13. Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse
  14. History of bone marrow or solid organ transplant
  15. History of heart failure
  16. History of major adverse cardiovascular events (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, stroke/transient ischemic attack (TIA)).
  17. History of atrial fibrillation or atrial flutter
  18. History of malignancy, other than non-melanoma skin cancer, that is currently being treated, or that has not been treated with definitive therapy and considered to be in remission.
  19. History of hypo- or hyperthyroidism requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion)
  20. History of adrenal disease
  21. History of cirrhosis
  22. History of stage 4 or 5 chronic kidney disease or requiring dialysis
  23. History of HIV/AIDS
  24. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
  25. History of obstructive sleep apnea (not on stable positive pressure therapy or other treatment for at least 3 months prior to enrollment)
  26. Abnormal screening labs: renal dysfunction (eGFR < 30 ml/min/1.73 m2), anemia, hypo- or hyperthyroidism, coagulopathy, abnormal liver function (AST, ALT > 3x upper limit of normal)

Sites / Locations

  • Altman Clinical and Translational Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Standard of Care (SOC)

TRE + SOC

Arm Description

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

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

Outcomes

Primary Outcome Measures

Effects of TRE on body weight
Measured as weight (kg).
Effects of TRE on body composition
Measured as percent body fat.
Effects of TRE on catecholamine sensitivity of obese adipose tissue (Exploratory Outcome)
Measured as release of free fatty acids (uM).
Effects of TRE on inflammation in obese adipose tissue (Exploratory Outcome)
Measured as inflammatory marker mRNA.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2021
Last Updated
July 26, 2023
Sponsor
University of California, San Diego
Collaborators
Salk Institute for Biological Studies
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1. Study Identification

Unique Protocol Identification Number
NCT04916730
Brief Title
Effect of Time-restricted Eating on Catecholamine-sensitivity of Adipose Tissue in Obese Adults
Official Title
Effect of Time-restricted Eating on Catecholamine-sensitivity of Adipose Tissue in Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2019 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
In a randomized controlled trial, the investigators intend to measure the health impact of time-restricted eating (TRE) in obese patients (body mass index (BMI) ≥ 30 kg/m2), who habitually eat for more than 14 hours every day. Patients will be randomly assigned to a control group of behavioral nutritional counseling (standard of care) or the intervention group of behavioral nutrition counseling with the addition of adopting a 10-hour eating window for 12 weeks (TRE).
Detailed Description
The current worldwide epidemic of obesity puts millions of people at increased risk for cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM), and while insulin resistance has been a traditional focus of treatment, resistance to catecholamines in obesity is likely a key factor hampering weight loss efforts. Catecholamines are key drivers of lipolysis in adipose tissue and bind to beta-3 adrenergic receptors (ADRB3) on the surface of adipocytes. Chronic inflammation is characteristic of obesity and suppresses the expression of adipocyte ADRB3, increasing fat storage. This leaves adipose tissue metabolically inflexible and in a state of energy preservation instead of burning fat to promote and maintain weight loss. Thus, catecholamine resistance of adipose tissue is an important target for lifestyle and therapeutic intervention. Time-restricted eating (TRE) is a therapeutic intervention that promotes weight loss and healthier metabolism by aligning dietary intake with circadian rhythms. In this RCT, individuals with obesity will be enrolled in a 14-week study of TRE and behavioral nutritional counseling vs behavioral nutritional counseling alone. In the TRE group, dietary intake will be limited to a self-selected 10-hour window. Information will be collected about adipose tissue catabolism (lipolysis) using samples collected by adipose tissue biopsy of subcutaneous abdominal adipose tissue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Key words provided by Michael Wilkinson, MD, University of California San Diego:, Catecholamine Sensitivity, Circadian Rhythm, Fasting, Obesity, Time Restricted Eating, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care (SOC)
Arm Type
Placebo Comparator
Arm Description
Participants will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.
Arm Title
TRE + SOC
Arm Type
Experimental
Arm Description
Participants in this arm will receive standard of care nutritional behavioral counseling and will implement a daily, self-selected, 10-hour window within which they must consume all calories. They will also be required to log their caloric intake through the use of a smartphone app
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
Participants in this arm will receive nutritional counseling from the study dietician but will not be required to adopt a 10-hr eating window.
Intervention Type
Behavioral
Intervention Name(s)
Time Restricted Eating
Intervention Description
Participants in this arm will adhere to a daily, consistent self-selected 10-hr eating window for the course of the study intervention period as well as receive nutritional counseling from the study dietitian.
Primary Outcome Measure Information:
Title
Effects of TRE on body weight
Description
Measured as weight (kg).
Time Frame
Baseline to 14 weeks
Title
Effects of TRE on body composition
Description
Measured as percent body fat.
Time Frame
Baseline to 14 weeks
Title
Effects of TRE on catecholamine sensitivity of obese adipose tissue (Exploratory Outcome)
Description
Measured as release of free fatty acids (uM).
Time Frame
Baseline to 14 weeks
Title
Effects of TRE on inflammation in obese adipose tissue (Exploratory Outcome)
Description
Measured as inflammatory marker mRNA.
Time Frame
Baseline to 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: ≥ 18 years old BMI 30-50 kg/m2 Own a smartphone with Apple iOS or Android OS Baseline eating window ≥ 14 hours/day 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 drugs, no dose adjustments will be allowed during the study period. Exclusion Criteria: Taking insulin or anti-diabetic medications within the last 6 months. Manifest diabetes, defined as fasting glucose ≥ 126 mg/dL, HbA1c ≥ 6.5%, or diagnosis of diabetes. Currently taking any medication that is meant for, or has known effect on, appetite or body weight Pregnant or breast-feeding women. Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. Shift workers with variable (e.g. nocturnal) hours. Planned international travel (time zone changes) during study period. Taking therapeutic anticoagulation which might increase risk of bleeding from adipose tissue biopsy History of surgical intervention for weight loss. History of eating disorder Currently enrolled in a weight-loss or weight-management program On a special or prescribed diet for other reasons (e.g. Celiac disease) Known inflammatory and/or rheumatologic disease Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse History of bone marrow or solid organ transplant History of heart failure History of major adverse cardiovascular events (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, stroke/transient ischemic attack (TIA)). History of atrial fibrillation or atrial flutter History of malignancy, other than non-melanoma skin cancer, that is currently being treated, or that has not been treated with definitive therapy and considered to be in remission. History of hypo- or hyperthyroidism requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion) History of adrenal disease History of cirrhosis History of stage 4 or 5 chronic kidney disease or requiring dialysis History of HIV/AIDS Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness). History of obstructive sleep apnea (not on stable positive pressure therapy or other treatment for at least 3 months prior to enrollment) Abnormal screening labs: renal dysfunction (eGFR < 30 ml/min/1.73 m2), anemia, hypo- or hyperthyroidism, coagulopathy, abnormal liver function (AST, ALT > 3x upper limit of normal)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Padilla, BS
Phone
858-246-2510
Email
PreventiveCVresearch@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Wilkinson, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altman Clinical and Translational Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Padilla, BS
Phone
858-246-2510

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Time-restricted Eating on Catecholamine-sensitivity of Adipose Tissue in Obese Adults

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