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. 2021 Jan 29;2021(1):CD013496. doi: 10.1002/14651858.CD013496.pub2

NCT02606669.

Methods Randomised controlled trial
Participants Ages eligible for study: 21 years to 70 years (adult, older adult)
Sexes Eligible for Study: All
Accepts healthy volunteers: yes
Criteria
Inclusion criteria:
Ability to provide informed consent.
Chinese. (both parents must be Chinese)
Age above 21 years old. This study will focus only on adult participants, and 21 years old is chosen as the age cut off, as it is the recognised legal age of independent consent.
BMI ≥ 25 kg/m2
Interventions Experimental: intermittent fasting
The intervention of interest here is the Intermittent Energy Restriction (IER) or the Intermittent Fasting approach, specifically, the "twice‐weekly" diet, where adherence to this dietary intervention consists of fasting for two consecutive days and consuming enough to meet energy requirements for the remaining five days. In this study, fasting will be achieved by using a meal replacement product (Optifast®) supplemented by two scoops of protein powder (Propass®) and a multivitamin, making a total of 540kcal (54g protein, 60g carbohydrates) for each fasting day.
Dietary supplement: meal replacement
Using a meal‐replacement product, supplemented by protein powder and multivitamin
No Intervention: control
Diet and physical activity advice only. no treatment plan.
Outcomes Primary outcome measures:
Change in total body weight (in kg) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]

Secondary outcome measures:
Change in quality of life (as determined by RAND Short Form‐36 health survey) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
Change in insulin sensitivity % (as determined by the Homeostasis Model Assessment (HOMA)) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
Change in total cholesterol levels (in mmol/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
Change in low‐density lipoprotein (LDL)‐ cholesterol levels (in mmol/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
Change in high‐density lipoprotein (HDL)‐cholesterol levels (in mmol/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
Change in triglyceride levels (in mmol/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
Change in waist circumference (in cm) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
Change in body fat % (as determined by bio‐electrical impedance analysis) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
Change in hip circumference (in cm) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
Change in alanine transaminase (ALT) levels (in U/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
Change in aspartate aminotransferase (AST) levels (in U/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
Change in gamma‐glutamyl transpeptidase (GGT) levels (in U/L) at 3 months compared to baseline [ Time Frame: Baseline to 3 months ]
Notes NCT02606669 ‐ It is unclear from the information above that the intervention meets our predefined criteria.