TREAT to Improve Cardiometabolic Health

NCT04465721 | Active Not Recruiting DMC

• 2 other identifiers: AAAS7791R01AG065569
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Overweight and Obesity; Prediabetes

Keywords

Overweight; Obesity; Metabolic syndrome; Time restricted eating; Diabetes; Prediabetes; Lifestyle intervention; Smartphone app

Outcome Measures

Primary Outcomes (8)

• 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.

  0, 3, and 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.

  0, 3 months

• 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.

  0, 3, 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.

  0, 3, 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.

  0, 3,12 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.

  0, 3,12 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.

  0, 3,12 months

• Adherence

  Adherence will be assessed by % of days with at least 2 or more entries logged at least 5h apart/day

  0, 3,12 months

Secondary Outcomes (9)

• Diet composition by ASA24

  0, 3, 12 months

• Matsuda Index (Insulin resistance)

  0, 3 months

• Insulinogenic Index

  0, 3 months

• Free fatty acids (FFA)

  0, 3, 12 months

• Ketones

  0, 3, 12 months

Study Arms (2)

HABIT Group

ACTIVE COMPARATOR

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

Behavioral: HABIT

TRE Group

EXPERIMENTAL

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

Behavioral: TRE

Interventions

TRE BEHAVIORAL

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.

TRE Group

HABIT BEHAVIORAL

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.

HABIT Group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• % 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• New York University: collaborator
• Salk Institute for Biological Studies: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (4)

• Santos-Baez LS, Ravelli MN, Diaz-Rizzolo DA, Popp CJ, Gallagher D, Cheng B, Schoeller D, Laferrere B. Dietary misreporting: a comparative study of recalls vs energy expenditure and energy intake by doubly-labeled water in older adults with overweight or obesity. BMC Med Res Methodol. 2025 Apr 26;25(1):115. doi: 10.1186/s12874-025-02568-4.

  PMID: 40287632 DERIVED

• Diaz-Rizzolo DA, Santos Baez LS, Popp CJ, Borhan R, Sordi-Guth A, Manoogian ENC, Panda S, Cheng B, Laferrere B. Late eating is associated with poor glucose tolerance, independent of body weight, fat mass, energy intake and diet composition in prediabetes or early onset type 2 diabetes. Nutr Diabetes. 2024 Oct 25;14(1):90. doi: 10.1038/s41387-024-00347-6.

  PMID: 39455572 DERIVED

• Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

  PMID: 38375882 DERIVED

• 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.

  PMID: 35934281 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Prediabetic State; Metabolic Syndrome; Intermittent Fasting; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Fasting; Feeding Behavior; Behavior

Study Officials

• Blandine Laferrère, M.D., Ph.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 10, 2020
• Study Start: June 14, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (1)