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TREAT for Metabolic Health

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Giriş yapmak kayıt olmak
Bağlantı panoya kaydedilir
DurumHenüz işe almıyor
Sponsorlar
Columbia University
Ortak çalışanlar
New York University
Salk Institute for Biological Studies

Anahtar kelimeler

Öz

Over half of adult Americans have overweight or obesity, have prolonged daily eating duration into late hours and are at increased risk of developing type 2 diabetes, hypertension and cardiovascular diseases.There is an urgent need for easy-to-implement intervention to slow progression of chronic diseases in mid-life adults. The investigators propose to test the effect of a life style intervention, delivered via a smartphone application, to restrict the eating window to only 10 hours/day, or time restricted eating (TRE), in metabolically unhealthy adults who eat habitually for more than 14 hours a day. The investigators hypothesize that eating for a shorter window of time will result in weight loss, improve sleep and metabolism, and decrease cardiovascular risk burden.

Açıklama

American adults have a high prevalence of overweight, obesity and prediabetes. Small weight loss delays the progression to type 2 diabetes and decreases cardiovascular risk, yet adherence to long-term calorie restriction is difficult to sustain. There is an urgency to find effective, easy-to-implement and to sustain, affordable lifestyle interventions. Restricting the food intake interval, or TRE has been shown in small-scale pilot studies to result in weight loss and improve metabolism, while being less challenging than intervention focusing on calorie restriction. The investigators propose to rigorously assess the efficacy of 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 14h/day, will be randomized to a restricted eating window to 10h/d (TRE) or to their habitual eating window (≥14h, HABIT), and followed up to 12 months. Ambulatory measures of food intake, sleep, physical activity and glucose, and in-patient 24-h 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; 2) Adherence to TRE will associate with the short-term effect (3 months) and the long-term sustainability (12 months) of TRE on fat mass loss. 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 lifestyle intervention

Tarih

Son Doğrulandı: 06/30/2020
İlk Gönderilen: 06/30/2020
Tahmini Kayıt Gönderildi: 07/05/2020
İlk Gönderilen: 07/09/2020
Son Güncelleme Gönderildi: 07/05/2020
Son Güncelleme Gönderildi: 07/09/2020
Fiili Çalışma Başlangıç Tarihi: 08/31/2020
Tahmini Birincil Tamamlanma Tarihi: 11/30/2024
Tahmini Çalışma Tamamlanma Tarihi: 08/31/2025

Durum veya hastalık

Overweight and Obesity
Prediabetes

Müdahale / tedavi

Behavioral: TRE

Behavioral: HABIT

Evre

-

Kol Grupları

KolMüdahale / tedavi
Active Comparator: HABIT
Participants randomized to the HABIT group will maintain their habitual eating schedule (≥14-h).
Behavioral: HABIT
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.
Experimental: TRE
Participants randomized to TRE will reduce their eating window to a self-selected eating window (≤10-h).
Behavioral: TRE
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.

Uygunluk kriterleri

Çalışmaya Uygun Yaşlar 50 Years İçin 50 Years
Çalışmaya Uygun CinsiyetlerAll
Sağlıklı Gönüllüleri Kabul EdiyorEvet
Kriterler

Inclusion Criteria:

- BMI ≥25 and ≤35kg/m2;

- prediabetes (ADA criteria 2019) or T2D diet-controlled, and/or treated with metformin only, with HbA1C ≤7%;

- controlled BP on stable regimen or stage 1 hypertension 130-139/80-89mmHg, meeting AHA hypertension clinical practice guidelines for lifestyle intervention;

- on stable regimen for dyslipidemia or triglycerides <300 mg/dl;

- in possession of a smart phone;

- with habitual wake up time after 5AM, average bed time between 21:30 and 24:00 and with average hours of sleep ≥6h;

- who habitually eat breakfast;

- with weight stability within 5% of screening for the last 3 months;

- sedentary to moderately active (<7500 steps/d);

- English speaking (the App has not yet been translated in Spanish).

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 identified at screening with the Epworth Sleepiness Scale score >10, 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 (e.g., prior or current diagnosis, current Beck depression inventory (BDI-II)>13; Beck anxiety inventory (BAI)>10);

- 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);

- consume large amounts of caffeine daily (>2 cups of coffee or 8 oz caffeinated drinks per day);

- participate in intense exercise (causing heavy breathing and sweating, such as jogging) >2 d/wk for ≥35 min or moderate exercise (e.g., brisk walking) for >150 min/wk;

- anemia and/or blood donation in 2-mo prior to inpatient studies;

- 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 chronotype;

- food allergies;

- unwilling/unable to provide informed consent.

Sonuç

Birincil Sonuç Ölçütleri

1. Fat mass [0, 3, and 12 months]

Changes in fat mass (kg) will be measured by quantitative magnetic resonance (QMR) on day 1 and day 14 of ambulatory assessments at the 0 and 3 month study period, and again at 12 months.

2. Energy intake [0, 3 months]

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 14 day ambulatory assessments of the 0 and 3 month study periods: EI (kcal/d) = EEDLW + ΔES.

3. Body weight [0, 3, 12 months]

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.

4. Insulin resistance (HOMA-IR) [0, 3, 12 months]

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.

5. Glucose levels [0, 3,12 months]

Glucose changes will be assessed by the total and incremental 24-hour glucose AUC, from ambulatory CGM at 0, 3, and 12 months, and from 24-h hourly sampling inpatient studies at 0 and 3 months.

6. Glucose variability [0, 3,12 months]

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, and again at 12 months.

7. Sleep assessment [0, 3,12 months]

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.

8. Respiratory Quotient (RQ) [0, 3 months]

Changes in RQ will be measured after an overnight fast during inpatient studies at 0 and 3 months, by indirect calorimetry.

9. Adherence [0, 3,12 months]

Adherence will be assessed with: number of days with log entries, number of log entries /day, number of days meeting target eating window (≤10-h) and mean reduction in duration of eating window for the TRE group.

İkincil Sonuç Ölçütleri

1. Diet composition by ASA24 [0, 3, 12 months]

% 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.

2. Matsuda Index (Insulin resistance) [0, 3 months]

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)])

3. Insulinogenic Index [0, 3 months]

Calculated by the AUC insulin/AUC glucose during OGTT.

4. Free fatty acids (FFA) [0, 3 months]

Calculated by the 24-hour AUC from 24-h hourly blood sampling

5. Ketones [0, 3, 12 months]

The concentration of ketones (beta-OH-butyrate) will be measured from a fasting blood sample.

6. Physical activity [0, 3, 12 months]

Assessed by step count during 14 day ambulatory assessment periods at 0,3, and 12 months.

7. Inflammation markers [0, 3, 12 months]

Measured from a fasting blood sample.

8. Oxidative stress [0, 3, 12 months]

Measured from a fasting blood sample

9. Lipid profile [0, 3, 12 months]

Measured from a fasting blood sample

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