メタボリックシンドロームにおける代謝および神経内分泌の恒常性、炎症および酸化ストレスに対する時間制限のある食事の影響 (TREMNIOS)
メタボリックシンドローム患者の代謝および神経内分泌の恒常性、炎症および酸化ストレスに対する時間制限のある食事の影響：TREMNIOSパイロット臨床試験
The main purpose of the clinical trial is to determine the health impact of a dietary intervention known as time-restricted eating (TRE) in patients with metabolic syndrome (defined as the presence of elevated fasting plasma glucose and two or more of the following criteria: increased waist circumference, elevated fasting plasma triglycerides, reduced high-density lipoprotein-cholesterol, elevated blood pressure) and self-reported dietary intake of ≥14 hours per day. Participants will reduce the amount of time they eat to 10 hours per day over a 12-week monitored intervention followed by a 12-week self-directed intervention and will log their dietary intake using a smartphone application (myCircadianClock (mCC) app). Glucose homeostasis (blood glucose levels will be monitored continuously for 2 weeks at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention using a continuous glucose monitor), and other metabolic, neuroendocrine, inflammatory and oxidative stress/antioxidant defense biomarkers, body weight and composition, blood pressure, heart rate, sleep and activity (using mCC app), personal sense of wellness and dietary timing (using health questionnaires) will be evaluated at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention.
調査の概要
詳細な説明
Metabolic syndrome occurs in approximately 30% of adults and is associated with increased risk of cardiovascular disease and type 2 diabetes. Circadian rhythm disruption due to lifestyle including erratic eating patterns may lead to metabolic and neuroendocrine dysfunction, inflammation, oxidative stress, and cardiometabolic diseases. Maintaining a daily rhythm of eating and fasting cycles sustains a robust circadian rhythm which improves cellular bioenergetics and metabolism. Recent studies support the notion that restricting a period of food intake to 8-12 hours a day (time-restricted eating, TRE) can prevent and reverse obesity and metabolic dysfunction.
The main purpose of the clinical trial is to determine the health impact of TRE in patients with metabolic syndrome (defined as the presence of elevated fasting plasma glucose and two or more of the following criteria: increased waist circumference, elevated fasting plasma triglycerides, reduced high-density lipoprotein-cholesterol, elevated blood pressure) and self-reported dietary intake of ≥14 hours per day. Participants will reduce the amount of time they eat to 10 hours per day over a 12-week monitored intervention followed by a 12-week self-directed intervention and will log their dietary intake using a smartphone application (myCircadianClock (mCC) app, developed by the Salk Institute for Biological Studies). The participants will select a 10-h eating window that best suits their lifestyle. All food/beverages except water must be consumed within the time-interval. No further dietary restrictions will be applied. The participants will be provided with behavioral nutritional counseling by a dietician. Glucose homeostasis (blood glucose levels will be monitored continuously for 2 weeks at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention using a continuous glucose monitor), and other metabolic, neuroendocrine, inflammatory and oxidative stress/antioxidant defense biomarkers, body weight and composition, blood pressure, heart rate, sleep and activity (using mCC app), personal sense of wellness and dietary timing (using health questionnaires) will be evaluated at the baseline, at the end of the monitored intervention, and at the end of the self-directed intervention. The investigators will assess for compliance with TRE using mCC app.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Bydgoszcz、ポーランド
- Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
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Metabolic syndrome, defined as the presence of elevated fasting plasma glucose ≥ 100 mg/dL and two or more of the following criteria:
Elevated waist circumference: ≥ 102 cm in men, ≥ 88 cm in women; Fasting plasma triglycerides ≥ 150 mg/dL (or on drug treatment for elevated triglycerides); Reduced High-density lipoprotein (HDL)-cholesterol < 40 mg/dL in men, < 50 mg/dL in women (or drug treatment for reduced HDL-cholesterol); Elevated blood pressure, Systolic blood pressure ≥ 130 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg (or drug treatment for hypertension).
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BMI > 25
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Duration of eating period ≥ 14 hours/day.
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Own a Smartphone with Apple Operating System (OS) or Android OS.
Exclusion Criteria:
- Diagnosis of diabetes.
- Pregnant or lactating women.
- Active smoking or illicit drug use or history of treatment for alcohol abuse.
- Shift work.
- Caregivers for dependent requiring nocturnal care.
- Planned travel over time zones during the study period.
- History of major adverse cardiovascular event within the past 1 year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack) or current uncontrolled arrhythmia.
- Uncontrolled medical conditions due to rheumatologic, hematologic, oncologic, infectious, gastrointestinal, psychiatric, nephrological, or endocrine diseases.
- Known history of an eating disorder.
- Currently enrolled in a weight-loss or weight-management program.
- Special or prescribed diet for other reasons (e.g. Celiac disease).
- Current treatment with antidepressants, medications affecting appetite, or immunosuppression.
- History of bariatric surgery.
- A score of > 16 on the Epworth Sleepiness Scale.
- Depression determined by the Beck Depression Inventory.
- Failure to use the smartphone app for documentation during a 2-week baseline period.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：時間制限のある食事
|
Participants will reduce the amount of time they eat to 10 hours per day over a 12-week monitored intervention followed by a 12-week self-directed intervention and will log their dietary intake using a smartphone application (mCC app). The participants will select a 10-h eating window that best suits their lifestyle. All food/beverages except water must be consumed within the time-interval. No further dietary restrictions will be applied. The participants will be provided with behavioral nutritional counseling by a dietician. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in body weight
時間枠：Baseline and after 14 weeks
|
Body weight (kg) as measured in fasted state on a digital scale |
Baseline and after 14 weeks
|
|
Change in fasting glucose concentration
時間枠：Baseline and after 14 weeks
|
Fasting plasma glucose concentration (mg/dl) |
Baseline and after 14 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body weight
時間枠：Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
Body weight (kg) as measured in fasted state on a digital scale |
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
|
Body mass index
時間枠：Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
Body mass index (kg/m^2) as calculated from body weight (kg) and height (m) |
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
|
Mean glucose
時間枠：Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
|
Glucose levels as measured by continuous glucose monitor (mg/dl) for 14 days at baseline, after 14 weeks, and after 26 weeks |
Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
|
|
Fasting glucose
時間枠：Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
|
Fasting glucose levels as measured by continuous glucose monitor (mg/dl) for 14 days at baseline, after 14 weeks, and after 26 weeks |
Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
|
|
Lipids
時間枠：Changes from baseline. Measured in the blood in the fasted state at baseline, after 14 weeks, and after 26 weeks
|
Fasting blood concentrations of lipids: total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), and triglycerides (mg/dl) |
Changes from baseline. Measured in the blood in the fasted state at baseline, after 14 weeks, and after 26 weeks
|
|
Fat mass
時間枠：Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
Fat mass percentage (%) as measured by body composition analyzer (using bioelectric impendence technology) |
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
|
HbA1c
時間枠：Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
HbA1c (%) assessed from blood samples |
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
|
Metabolic and neuroendocrine biomarkers
時間枠：Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
Fasting blood concentrations of metabolic and neuroendocrine biomarkers including but not limited to: free fatty acids, insulin, insulin-like growth factor-1, resistin, adiponectin, leptin, visfatin, irisin, ghrelin, omentin-1, and melatonin |
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
|
Inflammatory biomarkers
時間枠：Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
Fasting blood concentrations of inflammatory biomarkers including but not limited to: high sensitivity C-reactive protein, interleukin-6, interleukin-8, interleukin-10, tumor necrosis factor-α, tumor growth factor-β1, growth/differentiation factor 15 |
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
|
Oxidative stress/antioxidant defense biomarkers
時間枠：Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
Fasting blood concentrations of oxidative stress/antioxidant defense biomarkers including but not limited to: superoxide dismutase-1, catalase, glutathione peroxidase, oxidized LDL, thiobarbituric acid reactive substances, conjugated dienes, malondialdehyde, 4-hydroxynonenal, vitamin A, and vitamin E |
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
|
Waist circumference
時間枠：Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
Waist circumference (cm) as measured using tape measure |
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
|
Blood pressure
時間枠：Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
Systolic and diastolic blood pressure (mmHg) measured under resting and fasting conditions |
Changes from baseline. Fasted state at baseline, after 14 weeks, and after 26 weeks
|
|
Heart rate
時間枠：Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
|
Heart rate (bpm) measured under resting conditions during measurements of blood pressure |
Changes from baseline. Measured at baseline, after 14 weeks, and after 26 weeks
|
|
Energy intake
時間枠：Registered at baseline, after 14 weeks, and after 26 weeks
|
Energy intake (kcal/day) assessed from diet records |
Registered at baseline, after 14 weeks, and after 26 weeks
|
|
Timing of dietary intake
時間枠：Changes from baseline. Registered at baseline, after 14 weeks, and after 26 weeks
|
Timing of dietary intake (hh:mm) assessed from diet records and from the chrono-nutrition questionnaire |
Changes from baseline. Registered at baseline, after 14 weeks, and after 26 weeks
|
|
Self-reported sleepiness
時間枠：Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
|
Self-reported sleepiness as assessed from the questionnaire the Epworth Sleepiness Scale |
Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
|
|
Self-reported sleep quality
時間枠：Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
|
Self-reported sleep quality as assessed from the questionnaire Pittsburgh Sleep Quality Index |
Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
|
|
Self-reported chronotype
時間枠：Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
|
Self-reported chronotype as assessed from the Munich Chronotype Questionnaire |
Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
|
|
Self-reported overall health and wellbeing
時間枠：Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
|
Self-reported overall health and wellbeing as assessed from the questionnaire Self-reported health (SF-36 health survey) |
Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
|
|
Duration of eating period
時間枠：Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
|
Duration from the first to last caloric intake over 24-hour cycle, collected via the smartphone app (mCC app) |
Changes from baseline. Assessed at baseline, after 14 weeks, and after 26 weeks
|
協力者と研究者
捜査官
- 主任研究者：Iwona Swiatkiewicz, MD, PhD、Nicolaus Copernicus University, Collegium Medicum Bydgoszcz
出版物と役立つリンク
一般刊行物
- Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.
- Chaix A, Zarrinpar A, Miu P, Panda S. Time-restricted feeding is a preventative and therapeutic intervention against diverse nutritional challenges. Cell Metab. 2014 Dec 2;20(6):991-1005. doi: 10.1016/j.cmet.2014.11.001.
- Gill S, Le HD, Melkani GC, Panda S. Time-restricted feeding attenuates age-related cardiac decline in Drosophila. Science. 2015 Mar 13;347(6227):1265-9. doi: 10.1126/science.1256682.
- Pot GK, Almoosawi S, Stephen AM. Meal irregularity and cardiometabolic consequences: results from observational and intervention studies. Proc Nutr Soc. 2016 Nov;75(4):475-486. doi: 10.1017/S0029665116000239. Epub 2016 Jun 22.
- Gill S, Panda S. A Smartphone App Reveals Erratic Diurnal Eating Patterns in Humans that Can Be Modulated for Health Benefits. Cell Metab. 2015 Nov 3;22(5):789-98. doi: 10.1016/j.cmet.2015.09.005. Epub 2015 Sep 24.
- Sulli G, Manoogian ENC, Taub PR, Panda S. Training the Circadian Clock, Clocking the Drugs, and Drugging the Clock to Prevent, Manage, and Treat Chronic Diseases. Trends Pharmacol Sci. 2018 Sep;39(9):812-827. doi: 10.1016/j.tips.2018.07.003. Epub 2018 Jul 27.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NCU CM IRB 107/2019
個々の参加者データ (IPD) の計画
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