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Early vs. Late Time Restricted Eating vs. Daily Caloric Restriction (Time2Eat)

Primary Purpose

Overweight and Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early TRE
Late TRE
DCR
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adult males and females with a BMI of 27-45 kg/m2 Age, 18-65 years old Passing medical and physical screening, and analysis of blood and urine screening samples Typical eating duration >12 hours per day (assessed by questionnaires) Own a smartphone No plans to relocate within the next 12 months Capable and willing to give informed consent, understand exclusion criteria, and accept the randomized group assignment. Have a primary care physician (or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions. Exclusion Criteria: Pregnancy or lactation for women (women who are >6 months postpartum with no plans of becoming pregnant in the next year and who are not currently lactating can be included; oral contraceptives will be allowed if medication has been consistent for the prior 6 months) Weight loss >5kg in past 3 months for any reason except post-partum weight loss, weight gain >5kg in past 3 months requires assessment by PI to determine reason for weight gain and if it is appropriate for the subject to participate in the study Weight loss of >50 lbs in past 3 years for any reason except post-partum weight loss Presence or history of any metabolic or chronic health problems which would affect appetite, food intake, energy metabolism, or ability to optimally participate in the exercise component including: CVD, peripheral vascular disease, cerebrovascular disease, significant cardiac arrhythmias or cardiac valve disease, diabetes, uncontrolled hyper- or hypothyroidism, uncontrolled hypertension, cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis), HIV infection, significant gastrointestinal disorders (described below), significant pulmonary disorders (described below), significant renal, musculoskeletal, neurologic, hematologic, or psychiatric disease. Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, Ulcerative Colitis, chronic diarrhea, or active gallbladder disease. Significant pulmonary disorders including: chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, or uncontrolled asthma. Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope. Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician Having abnormal blood chemistry (eGFR<45mL/min, AST or ALT >3 times the upper limit of normal) or as deemed significant by the study physician Being considered unsafe to participate as determined by the study physician Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed > 1 year before screening, (2) lap banding if the band has been removed > 1 year before screening, (3) intragastric balloon if the balloon has been removed > 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed > 1 year before screening. Being a smoker or having been a smoker in the 3 months prior to their screening visit Working night shifts Typical wake time earlier than 6AM Night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week) as assessed with meal pattern assessment questionnaire History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score >20 on the EATS-26 or pattern of response on the QEWP-5 suggestive of possible binge eating disorder or bulimia will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study. Current alcohol or substance abuse (assessed with CAGE-AID questionnaire (48)) Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score > 18 on BDI will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.

Sites / Locations

  • University of Colorado Anschutz Health and Wellness Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Early time restricted eating

Late time restricted eating

Daily caloric restriction

Arm Description

Participants will asked to follow early time restricted eating

Participants will be asked to follow late time restricted eating

Participants will be instructed to follow daily caloric restriction

Outcomes

Primary Outcome Measures

Body weight (kg)
Body weight will be measured using a digital scale at baseline, weeks 14, 26 and 52. The primary outcome will be change in weight from baseline to 26 weeks.

Secondary Outcome Measures

Fat mass
Fat mass will assessed using Dual-Energy X-Ray Absorptiometry (DXA) at baseline, weeks 14, 26 and 52
Lean mass
Lean mass will assessed using Dual-Energy X-Ray Absorptiometry (DXA) at baseline, weeks 14, 26 and 52
Blood pressure
Systolic and diastolic blood pressure will be measured at baseline and weeks 14, 26 and 52
HbA1c
HbA1c will be measured at baseline and weeks 14, 26 and 52
Insulin sensitivity
Insulin sensitivity measured with oral glucose tolerance test at baseline and weeks 14, 26 and 52
24-hour glucose levels
24-hr glucose levels measured with continuous glucose monitor at baseline and weeks 14, 26 and 52
Physical activity
Total steps measured with activPal device at baseline and weeks 14, 26 and 52
Total cholesterol concentration
Total cholesterol concentration will be measured at baseline and weeks 14, 26 and 52
Sleep duration
Sleep duration (minutes) will be measured with activPal device at baseline and weeks 0, 14 and 26
LDL cholesterol concentration
Low density lipoprotein (LDL) will be measured at baseline and weeks 14, 26 and 52
HDL cholesterol concentration
High density lipoprotein (HDL) cholesterol concentration will be measured at baseline and weeks 14, 26 and 52
Triglyceride concentration
Triglyceride concentration will be measured at baseline and weeks 14, 26 and 52

Full Information

First Posted
May 4, 2023
Last Updated
May 12, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05870982
Brief Title
Early vs. Late Time Restricted Eating vs. Daily Caloric Restriction
Acronym
Time2Eat
Official Title
Effects of Early vs. Late Time Restricted Eating vs. Daily Caloric Restriction on Weight Loss and Metabolic Outcomes in Adults With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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
The goal of this clinical trial is to learn about time restricted eating as a weight loss intervention in adults with obesity. The main questions it aims to answer are: How does the timing of the eating window (early vs late time restricted eating) affect weight loss and changes in metabolic risk factors? How does time restricted eating compare to standard of care (daily caloric restriction) for weight loss and changes in metabolic risk factors? Participants will be randomly assigned to either early time restricted eating, late time restricted eating, or daily caloric restriction. They will be asked to follow the assigned dietary strategy for 1 year and will receive a group-based program for instruction and support. They will be asked at several times during the year to have their weight and body composition measured, provide blood samples, track their food, and wear monitors for physical activity and sleep.
Detailed Description
This is a 52-week randomized, parallel-arm clinical trial designed to assess the effects of early time restricted eating (E-TRE) vs late TRE (L-TRE) vs daily caloric restriction (DCR) within the context of a guidelines-based behavioral weight loss program. 162 adults (age 18-65) with obesity (BMI 27-45 kg/m2) will be recruited from the community and randomized 1:1:1 to E-TRE (eating within an 8-hour window starting 1-2 hours after waking), L-TRE (eating within an 8-hour window starting 5-6 hours after waking) or DCR (caloric restriction of 25% from baseline energy requirements). The primary outcome is change in body weight at 26 weeks. Secondary outcomes include body composition, insulin sensitivity, blood pressure, glucose variability, physical activity, and sleep.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, parallel-arm clinical trial
Masking
Investigator
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early time restricted eating
Arm Type
Experimental
Arm Description
Participants will asked to follow early time restricted eating
Arm Title
Late time restricted eating
Arm Type
Experimental
Arm Description
Participants will be asked to follow late time restricted eating
Arm Title
Daily caloric restriction
Arm Type
Active Comparator
Arm Description
Participants will be instructed to follow daily caloric restriction
Intervention Type
Behavioral
Intervention Name(s)
Early TRE
Intervention Description
Participants will be instructed to eat only during an 8-hour window starting 1-2 hours after waking.
Intervention Type
Behavioral
Intervention Name(s)
Late TRE
Intervention Description
Participants will be instructed to eat only during an 8-hour window starting 5-6 hours after waking.
Intervention Type
Behavioral
Intervention Name(s)
DCR
Intervention Description
Participants will be instructed to reduce caloric intake by 25%.
Primary Outcome Measure Information:
Title
Body weight (kg)
Description
Body weight will be measured using a digital scale at baseline, weeks 14, 26 and 52. The primary outcome will be change in weight from baseline to 26 weeks.
Time Frame
0 to 52 weeks
Secondary Outcome Measure Information:
Title
Fat mass
Description
Fat mass will assessed using Dual-Energy X-Ray Absorptiometry (DXA) at baseline, weeks 14, 26 and 52
Time Frame
0 to 52 weeks
Title
Lean mass
Description
Lean mass will assessed using Dual-Energy X-Ray Absorptiometry (DXA) at baseline, weeks 14, 26 and 52
Time Frame
0-52 weeks
Title
Blood pressure
Description
Systolic and diastolic blood pressure will be measured at baseline and weeks 14, 26 and 52
Time Frame
0-52 weeks
Title
HbA1c
Description
HbA1c will be measured at baseline and weeks 14, 26 and 52
Time Frame
0-52 weeks
Title
Insulin sensitivity
Description
Insulin sensitivity measured with oral glucose tolerance test at baseline and weeks 14, 26 and 52
Time Frame
0-52 weeks
Title
24-hour glucose levels
Description
24-hr glucose levels measured with continuous glucose monitor at baseline and weeks 14, 26 and 52
Time Frame
0-52 weeks
Title
Physical activity
Description
Total steps measured with activPal device at baseline and weeks 14, 26 and 52
Time Frame
0-52 weeks
Title
Total cholesterol concentration
Description
Total cholesterol concentration will be measured at baseline and weeks 14, 26 and 52
Time Frame
0-52 weeks
Title
Sleep duration
Description
Sleep duration (minutes) will be measured with activPal device at baseline and weeks 0, 14 and 26
Time Frame
0-52 weeks
Title
LDL cholesterol concentration
Description
Low density lipoprotein (LDL) will be measured at baseline and weeks 14, 26 and 52
Time Frame
0-52 weeks
Title
HDL cholesterol concentration
Description
High density lipoprotein (HDL) cholesterol concentration will be measured at baseline and weeks 14, 26 and 52
Time Frame
0-52 weeks
Title
Triglyceride concentration
Description
Triglyceride concentration will be measured at baseline and weeks 14, 26 and 52
Time Frame
0-52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult males and females with a BMI of 27-45 kg/m2 Age, 18-65 years old Passing medical and physical screening, and analysis of blood and urine screening samples Typical eating duration >12 hours per day (assessed by questionnaires) Own a smartphone No plans to relocate within the next 12 months Capable and willing to give informed consent, understand exclusion criteria, and accept the randomized group assignment. Have a primary care physician (or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions. Exclusion Criteria: Pregnancy or lactation for women (women who are >6 months postpartum with no plans of becoming pregnant in the next year and who are not currently lactating can be included; oral contraceptives will be allowed if medication has been consistent for the prior 6 months) Weight loss >5kg in past 3 months for any reason except post-partum weight loss, weight gain >5kg in past 3 months requires assessment by PI to determine reason for weight gain and if it is appropriate for the subject to participate in the study Weight loss of >50 lbs in past 3 years for any reason except post-partum weight loss Presence or history of any metabolic or chronic health problems which would affect appetite, food intake, energy metabolism, or ability to optimally participate in the exercise component including: CVD, peripheral vascular disease, cerebrovascular disease, significant cardiac arrhythmias or cardiac valve disease, diabetes, uncontrolled hyper- or hypothyroidism, uncontrolled hypertension, cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis), HIV infection, significant gastrointestinal disorders (described below), significant pulmonary disorders (described below), significant renal, musculoskeletal, neurologic, hematologic, or psychiatric disease. Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, Ulcerative Colitis, chronic diarrhea, or active gallbladder disease. Significant pulmonary disorders including: chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, or uncontrolled asthma. Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope. Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician Having abnormal blood chemistry (eGFR<45mL/min, AST or ALT >3 times the upper limit of normal) or as deemed significant by the study physician Being considered unsafe to participate as determined by the study physician Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed > 1 year before screening, (2) lap banding if the band has been removed > 1 year before screening, (3) intragastric balloon if the balloon has been removed > 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed > 1 year before screening. Being a smoker or having been a smoker in the 3 months prior to their screening visit Working night shifts Typical wake time earlier than 6AM Night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week) as assessed with meal pattern assessment questionnaire History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score >20 on the EATS-26 or pattern of response on the QEWP-5 suggestive of possible binge eating disorder or bulimia will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study. Current alcohol or substance abuse (assessed with CAGE-AID questionnaire (48)) Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score > 18 on BDI will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheila Steinke
Phone
303-724-3304
Email
sheila.steinke@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emilee Mickaliger
Email
emilee.mickaliger@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado Anschutz Health and Wellness Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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