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TREAT to Improve Cardiometabolic Health (NY-TREAT)

Primary Purpose

Overweight and Obesity, Prediabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TRE
HABIT
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity focused on measuring Overweight, Obesity, Metabolic syndrome, Time restricted eating, Diabetes, Prediabetes, Lifestyle intervention, Smartphone app

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age: 50-70y old
  • BMI ≥25 and ≤45 kg/m2

  • a diagnosis of prediabetes AND/OR fasting glucose 100 mg/dL and/or HbA1c 5.7% OR Type 2 Diabetes diet-controlled and/or treated with metformin AND meeting 2 or more of the following metabolic syndrome criteria:

    • diagnosis of hypertension on stable medication regimen
    • blood pressure >120/>80 mmHg
    • A diagnosis of dyslipidemia on stable regimen
    • triglycerides 150 mg/dL
    • HDL cholesterol men <40 mg/dL and women <50 mg/dL
    • waist circumference men: >102 cm (>40 in); women >88 cm (>35 in)
  • in possession of a smart phone (iPhone or Android)
  • 70% of days with logging adherence (2 or more log entries/day separated by at least 5h)
  • Sleep duration 6-h, with habitual self-reported wake up time >5AM and before 11 AM and average self reported bed time <2AM
  • habitually eat breakfast
  • with weight stability within 5% of screening for the last 3 months
  • English speaking (the App has not yet been translated)
  • must live in the New York City metro area

Exclusion criteria:

  • sleep disorder, e.g. known obstructive sleep apnea (OSA) on CPAP, severe OSA with apnea-hypopnea index >30 events/h, significant daytime symptoms of OSA, periodic limb movements of sleep, narcolepsy, current shift work or in last 6-mo, travel more than 1 time zone during intervention; severe insomnia with score 15 on Insomnia Severity Index
  • significant organ system dysfunction/disease: severe pulmonary, kidney or cardiovascular disease; evidence of active illness (e.g., fever)
  • history of seizure disorder
  • previous bariatric surgery or on weight loss medication
  • history of or current significant food intake or psychiatric disorder
  • use of dietary supplements and/or medications known to affect sleep, circadian rhythms or metabolic function
  • smoking tobacco or using illegal or recreational drugs
  • consume excessive alcohol (women: >14 drinks/wk; men: >21 drinks/wk)
  • anemia (hemoglobin <10 g/dl and hematocrit <30%)
  • have conditions that render individual unable to complete all testing procedures [e.g., unable to stay overnight or frequent travel across 1 time zones]
  • extreme early and late chronotypes (> 2AM bed time and wake up time before 5AM and > 11AM)
  • severe food allergies
  • unwilling/unable to provide informed consent

Sites / Locations

  • Columbia UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

HABIT Group

TRE Group

Arm Description

Participants randomized to the HABIT group will maintain their habitual eating schedule (≥13-h).

Participants randomized to TRE will reduce their eating window to a self-selected eating window (≤10-h).

Outcomes

Primary Outcome Measures

Fat mass
Changes in fat mass (kg) will be measured by quantitative magnetic resonance (QMR) on day 0 and day 13 of ambulatory assessments at the 0 and 3 month study period, and again at 12 months.
Energy intake
Energy intake (EI) will be calculated from total daily energy expenditure (EE) measured by doubly labeled water (DLW), and changes in body energy stores (ΔES), measured by QMR over the 2-wk ambulatory assessments of the 0 and 3 month study periods: EI (kcal/d) = EEDLW + ΔES.
Body weight
Changes in body weight (kg) will be measured to the nearest 0.01 kg with a digital scale at 0 and 3 months, and again at 12 months.
Insulin resistance (HOMA-IR)
Fasting serum insulin and plasma glucose concentrations will be used to calculate changes in insulin resistance (HOMA-IR): [fasting insulin (mU/mL) x fasting glucose (mmol/L)]/22.5 at 0 and 3 months, and again at 12 months.
Glucose levels
Glucose changes will be assessed by the total and incremental 24-hour glucose AUC, from ambulatory CGM at 0 and 3 months.
Glucose variability
CGM data will be used to calculate standard measures of glucose variability (GV), including mean amplitude of glycemic excursion (MAGE) changes at 0 and 3 months.
Sleep assessment
Sleep duration will be assessed by changes in bedtime, waketime, and total sleep time, recorded by actigraphy during the 2-wk ambulatory assessments at 0, 3, and 12 months.
Adherence
Adherence will be assessed by % of days with at least 2 or more entries logged at least 5h apart/day

Secondary Outcome Measures

Diet composition by ASA24
% of carbs, fat and protein in diet by ASA24 on 3 non-consecutive days (2 weekdays and one weekend day) during each ambulatory assessment and during the 3 months intervention.
Matsuda Index (Insulin resistance)
Fasting and OGTT glucose and insulin levels are used to calculate the Matsuda index: 10,000/([fasting insulin (mU/mL)x fasting glucose (mmol/L)]x [mean OGTT insulin (mU/mL) x mean OGTT glucose (mmol/L)])
Insulinogenic Index
Calculated by the AUC insulin/AUC glucose during OGTT.
Free fatty acids (FFA)
Measured from a fasting blood sample
Ketones
The concentration of ketones (beta-OH-butyrate) will be measured from a fasting blood sample.
Physical activity
Assessed by step count during 14 day ambulatory assessment periods at 0,3, and 12 months.
Inflammation markers
Measured from a fasting blood sample.
Oxidative stress
Measured from a fasting blood sample
Lipid profile
Measured from a fasting blood sample

Full Information

First Posted
July 1, 2020
Last Updated
September 18, 2023
Sponsor
Columbia University
Collaborators
New York University, Salk Institute for Biological Studies, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04465721
Brief Title
TREAT to Improve Cardiometabolic Health
Acronym
NY-TREAT
Official Title
New York TREAT (Time Restricted EATing) to Improve Cardiometabolic Health Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
New York University, Salk Institute for Biological Studies, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Over half of American adults have overweight or obesity and are at high risk of developing type 2 diabetes and cardiovascular diseases. Although caloric restriction has many health benefits, it is difficult to sustain overtime for most people. Time restricted eating (TRE), a novel type of intermittent fasting, facilitates adherence to the intervention and results in weight loss and improvement of metabolism. The investigators propose to to examine the efficacy of self monitoring and TRE (10-h/d) vs. self-monitoring and habitual prolonged eating duration ( HABIT) (13 hours/d) on weight loss and body composition, metabolic function and circadian biology, in metabolically unhealthy adults aged 50 to 75 y old, with overweight or obesity. The investigators hypothesize that TRE, compared to habitual long duration of eating, will decrease cardiovascular risk burden.
Detailed Description
American adults have a high prevalence of overweight, obesity and prediabetes. Small weight loss delays the progression to type 2 diabetes and decrease cardiovascular risk, yet adherence to long term calorie restriction is difficult to sustain. There is an urgency to find effective, easy-to implement and sustain, and affordable life style interventions. Restricting the food intake interval, or time restricted eating (TRE) has been shown in small-scale pilot studies to result in weight loss and improve metabolism, while being less challenging than calorie count. We propose to rigorously assess the efficacy and sustainability of self-monitoring with and without TRE, administered via a smartphone application, on weight loss and decreased cardiovascular risk. To achieve this goal, metabolically unhealthy mid-life adults with overweight or obesity who habitually eat for more than 13h/day, will be randomized to a self monitoring and restricted eating window to 10h/d (TRE) or to a self-monitoring and habitual eating window (13h, HABIT), and followed up to 12 months. Ambulatory measures of food intake, sleep, physical activity and glucose, and outpatient well controlled studies will be done to determine the effect of TRE versus habitual eating duration (HABIT), as well as the mediators of these effects. Hypotheses: 1) TRE vs. HABIT will result in decreased fat mass, measured by quantitative magnetic resonance, and effect mediated via decreased daily total energy intake, measured by double labeled water; 2) TRE vs. HABIT will result in lower insulin resistance, lower glycemia and shift in fuel utilization preferentially to lipid mobilization; 3) Adherence to the TRE intervention will be associated with greater weight loss at 3 months and weight maintenance at 12 months. Results from this study will provide important insights into understanding the physiological and molecular interactions between restricting daily eating interval and metabolic function, and could provide evidence for using TRE interventions to improve metabolic health and decrease cardiovascular risk in the large number of mid-life and older Americans in great need of life style intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Prediabetes
Keywords
Overweight, Obesity, Metabolic syndrome, Time restricted eating, Diabetes, Prediabetes, Lifestyle intervention, Smartphone app

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Metabolically unhealthy mid-life adults with overweight or obesity who habitually eat for more than 13h/day, will be randomized to a restricted eating window to 10h/d (TRE group) or to their habitual eating window (≥ 13h, HABIT group), and followed up to 12 months.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HABIT Group
Arm Type
Active Comparator
Arm Description
Participants randomized to the HABIT group will maintain their habitual eating schedule (≥13-h).
Arm Title
TRE Group
Arm Type
Experimental
Arm Description
Participants randomized to TRE will reduce their eating window to a self-selected eating window (≤10-h).
Intervention Type
Behavioral
Intervention Name(s)
TRE
Intervention Description
The TRE intervention will be administered and monitored via the study app. It combines self-monitoring behavior, daily eating window reminders, positive reinforcement based on number of log entries or based on meeting eating widow target, and basic lifestyle text messages. It also allows research staff to monitor in real-time, via the backend cloud, adherence to self-monitoring, and to reducing the eating window.
Intervention Type
Behavioral
Intervention Name(s)
HABIT
Intervention Description
The HABIT intervention will be administered and monitored via the study app. It combines self-monitoring behavior, positive reinforcement based on number of log entries, and basic lifestyle text messages. It also allows research staff to monitor in real-time, via the backend cloud, adherence to self-monitoring.
Primary Outcome Measure Information:
Title
Fat mass
Description
Changes in fat mass (kg) will be measured by quantitative magnetic resonance (QMR) on day 0 and day 13 of ambulatory assessments at the 0 and 3 month study period, and again at 12 months.
Time Frame
0, 3, and 12 months
Title
Energy intake
Description
Energy intake (EI) will be calculated from total daily energy expenditure (EE) measured by doubly labeled water (DLW), and changes in body energy stores (ΔES), measured by QMR over the 2-wk ambulatory assessments of the 0 and 3 month study periods: EI (kcal/d) = EEDLW + ΔES.
Time Frame
0, 3 months
Title
Body weight
Description
Changes in body weight (kg) will be measured to the nearest 0.01 kg with a digital scale at 0 and 3 months, and again at 12 months.
Time Frame
0, 3, 12 months
Title
Insulin resistance (HOMA-IR)
Description
Fasting serum insulin and plasma glucose concentrations will be used to calculate changes in insulin resistance (HOMA-IR): [fasting insulin (mU/mL) x fasting glucose (mmol/L)]/22.5 at 0 and 3 months, and again at 12 months.
Time Frame
0, 3, 12 months
Title
Glucose levels
Description
Glucose changes will be assessed by the total and incremental 24-hour glucose AUC, from ambulatory CGM at 0 and 3 months.
Time Frame
0, 3,12 months
Title
Glucose variability
Description
CGM data will be used to calculate standard measures of glucose variability (GV), including mean amplitude of glycemic excursion (MAGE) changes at 0 and 3 months.
Time Frame
0, 3,12 months
Title
Sleep assessment
Description
Sleep duration will be assessed by changes in bedtime, waketime, and total sleep time, recorded by actigraphy during the 2-wk ambulatory assessments at 0, 3, and 12 months.
Time Frame
0, 3,12 months
Title
Adherence
Description
Adherence will be assessed by % of days with at least 2 or more entries logged at least 5h apart/day
Time Frame
0, 3,12 months
Secondary Outcome Measure Information:
Title
Diet composition by ASA24
Description
% of carbs, fat and protein in diet by ASA24 on 3 non-consecutive days (2 weekdays and one weekend day) during each ambulatory assessment and during the 3 months intervention.
Time Frame
0, 3, 12 months
Title
Matsuda Index (Insulin resistance)
Description
Fasting and OGTT glucose and insulin levels are used to calculate the Matsuda index: 10,000/([fasting insulin (mU/mL)x fasting glucose (mmol/L)]x [mean OGTT insulin (mU/mL) x mean OGTT glucose (mmol/L)])
Time Frame
0, 3 months
Title
Insulinogenic Index
Description
Calculated by the AUC insulin/AUC glucose during OGTT.
Time Frame
0, 3 months
Title
Free fatty acids (FFA)
Description
Measured from a fasting blood sample
Time Frame
0, 3, 12 months
Title
Ketones
Description
The concentration of ketones (beta-OH-butyrate) will be measured from a fasting blood sample.
Time Frame
0, 3, 12 months
Title
Physical activity
Description
Assessed by step count during 14 day ambulatory assessment periods at 0,3, and 12 months.
Time Frame
0, 3, 12 months
Title
Inflammation markers
Description
Measured from a fasting blood sample.
Time Frame
0, 3, 12 months
Title
Oxidative stress
Description
Measured from a fasting blood sample
Time Frame
0, 3, 12 months
Title
Lipid profile
Description
Measured from a fasting blood sample
Time Frame
0, 3, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age: 50-75y old BMI ≥25 and ≤45 kg/m2 a diagnosis of prediabetes AND/OR fasting glucose 100 mg/dL and/or HbA1c 5.7% OR Type 2 Diabetes diet-controlled and/or treated with metformin AND meeting 2 or more of the following metabolic syndrome criteria: diagnosis of hypertension on stable medication regimen blood pressure >120/>80 mmHg A diagnosis of dyslipidemia on stable regimen triglycerides 150 mg/dL HDL cholesterol men <40 mg/dL and women <50 mg/dL waist circumference men: >102 cm (>40 in); women >88 cm (>35 in) in possession of a smart phone (iPhone or Android) 70% of days with logging adherence (2 or more log entries/day separated by at least 5h) Sleep duration 6-h, with habitual self-reported wake up time >5AM and before 11 AM and average self reported bed time <2AM habitually eat breakfast with weight stability within 5% of screening for the last 3 months English speaking (the App has not yet been translated) must live in the New York City metro area Exclusion criteria: sleep disorder, e.g. known obstructive sleep apnea (OSA) on CPAP, severe OSA with apnea-hypopnea index >30 events/h, significant daytime symptoms of OSA, periodic limb movements of sleep, narcolepsy, current shift work or in last 6-mo, travel more than 1 time zone during intervention; severe insomnia with score 15 on Insomnia Severity Index significant organ system dysfunction/disease: severe pulmonary, kidney or cardiovascular disease; evidence of active illness (e.g., fever) history of seizure disorder previous bariatric surgery or on weight loss medication history of or current significant food intake or psychiatric disorder use of dietary supplements and/or medications known to affect sleep, circadian rhythms or metabolic function smoking tobacco or using illegal or recreational drugs consume excessive alcohol (women: >14 drinks/wk; men: >21 drinks/wk) anemia (hemoglobin <10 g/dl and hematocrit <30%) have conditions that render individual unable to complete all testing procedures [e.g., unable to stay overnight or frequent travel across 1 time zones] extreme early and late chronotypes (> 2AM bed time and wake up time before 5AM and > 11AM) severe food allergies unwilling/unable to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rabiah Borhan, BS
Phone
212-851-5318
Email
rb3692@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Blandine Laferrere, MD, PhD
Phone
212-851-5562
Email
bbl14@columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blandine Laferrère, M.D., Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blandine Laferrere
Phone
212-851-5562
Email
bbl14@columbia.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Columbia University is committed to the open and timely dissemination of research outcomes. Investigators in this proposed project are aware of and agree to abide by the principles for sharing research resources, as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs." All data used in this proposal will de-identified, and accessed using a secure data area using a shared drive, protected by password only to be accessed by those directly involved in the clinical research. All transfer of data will use encrypted methods. Wherever applicable, fully de-identified data will be deposited to appropriate public repositories, following the Federal Health Insurance Privacy and Portability Act (HIPAA).
IPD Sharing Time Frame
This will occur no longer than 6 months after publications of the data generated by this application, or, 18 months after completion of the funding period, should no data had been published.
IPD Sharing Access Criteria
The data generated in this grant will be presented at national or international conferences and published in a timely fashion. All final peer-reviewed manuscripts that arise from this proposal will be submitted upon acceptance for publication to the digital archive NIH National Library of Medicine PubMed Central (PMC) database, according to the NIH Policy on Enhancing Public Access to Archived Publications Resulting from NIH Funded Research. Any data released for publication will be for research purposes only and will not include identifiable data on any of the participants.
Citations:
PubMed Identifier
35934281
Citation
Santos-Baez LS, Garbarini A, Shaw D, Cheng B, Popp CJ, Manoogian ENC, Panda S, Laferrere B. Time-restricted eating to improve cardiometabolic health: The New York Time-Restricted EATing randomized clinical trial - Protocol overview. Contemp Clin Trials. 2022 Sep;120:106872. doi: 10.1016/j.cct.2022.106872. Epub 2022 Aug 4.
Results Reference
derived

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TREAT to Improve Cardiometabolic Health

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