TREAT for Metabolic Health
Anahtar kelimeler
Öz
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
Müdahale / tedavi
Behavioral: TRE
Behavioral: HABIT
Evre
Kol Grupları
Kol | Müdahale / 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 Cinsiyetler | All |
Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
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]
2. Energy intake [0, 3 months]
3. Body weight [0, 3, 12 months]
4. Insulin resistance (HOMA-IR) [0, 3, 12 months]
5. Glucose levels [0, 3,12 months]
6. Glucose variability [0, 3,12 months]
7. Sleep assessment [0, 3,12 months]
8. Respiratory Quotient (RQ) [0, 3 months]
9. Adherence [0, 3,12 months]
İkincil Sonuç Ölçütleri
1. Diet composition by ASA24 [0, 3, 12 months]
2. Matsuda Index (Insulin resistance) [0, 3 months]
3. Insulinogenic Index [0, 3 months]
4. Free fatty acids (FFA) [0, 3 months]
5. Ketones [0, 3, 12 months]
6. Physical activity [0, 3, 12 months]
7. Inflammation markers [0, 3, 12 months]
8. Oxidative stress [0, 3, 12 months]
9. Lipid profile [0, 3, 12 months]