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. 2021 Jun 16;11(6):e045537. doi: 10.1136/bmjopen-2020-045537

Table 1.

Study outcomes

Primary outcome measures 1. Evaluate the impact of TRE on glucose homeostasis. The primary endpoint will be the change in glucose levels assessed via fasting blood glucose and continuous glucose monitors (CGM). Data from CGMs will be analysed to determine changes in glucose response within individuals and a daily average for glucose value will be computed.
2. Assess the feasibility and adherence of TRE. This will be measured by the percentage of days logged that participants ate within their TRE window and end-of-study surveys.
Secondary outcome measures 3. Assess changes in metabolic and neuroendocrine biomarkers in response to TRE. Cardiometabolic homeostasis will be measured with blood biochemistry (including, but not limited to, fasting glucose, HbA1c, cholesterol, triglycerides, NMR LipoProfile and hs-CRP). Neuroendocrine markers include insulin and leptin.
4. Systolic blood pressure (mm Hg) in response to TRE.
5. Diastolic blood pressure (mm Hg) in response to TRE.
6. Body weight (kg) in response to TRE.
Other outcomes 7. Body mass index (kg/m2).
8. Waist and hip circumference (cm).
9. Hip (cm)/waist (cm) ratio.
10. Body composition including, but not limited to, the fat percentage (%), fat mass (kg) and lean mass (kg).
11. Questionnaires (SF-36, ESS, PSQI, BDI).
Subanalyses 12. For each outcome measure (1–11), subanalyses will be done on participants in both arms who are outside the reference healthy range for the respective measures.

BDI, Beck Depression Inventory; ESS, Epworth Sleepiness Scale; hs-CRP, high-sensitivity C-reactive protein; NMR, nuclear magnetic resonance; PSQI, Pittsburgh Sleep Quality Index; SF-36, Short Form-36 Quality of Life; TRE, time-restricted eating.