Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effect of Intermittent Energy Restriction Using Meal Replacements in Overweight Chinese Subjects: a Pilot Randomized Control Trial
Brief Summary: Background and Aims: The "5:2 diet", a form of intermittent energy restriction, has been popularized in Europe and USA. The rationale behind this approach is that two days of dieting is potentially more achievable, yet long enough to reduce overall weekly energy intake. However, this specific approach is lacking in evidence. Therefore, we are keen to investigate the effectiveness of this form of intermittent energy restriction compared with a control intervention (providing dietary and exercise advice only), in overweight, Chinese subjects, for an intervention period of 12 weeks.

Design and Methods: This will be a randomized controlled trial, with 15 subjects in each arm, for an intervention period of 12 weeks. Subjects randomized to the treatment group will take three packets of a meal replacement product (Optifast®) per day during two consecutive fasting days, and take a healthy balanced diet that meet estimated energy requirements for the remaining five days. Subjects randomized to the control group will be given general diet advice and allowed to eat ad libitum throughout the study period. Measurements and laboratory tests will be done at baseline, 4 weeks and 12 weeks. Adherence to the dietary interventions will be assessed at 4 weeks and 12 weeks using 7-day food diaries.

Significance: This will be the first study looking at an Asian population and will serve as a pilot towards a larger randomized trial. If this approach is found to be safe, effective and easier to adhere compared to the traditional continuous energy restriction, then it will be a very valuable option in the treatment of obesity, which has become an increasing problem globally including Singapore.


Options:
A: Arm Label: Intermittent Fasting; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Meal Replacement | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DIETARY_SUPPLEMENT; Name: Meal Replacement; Assigned to Arm(s): Intermittent Fasting
B: Arm Label: Normal Feeding; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Time Restricted Feeding; Type: EXPERIMENTAL; Interventions: Behavioral: Time Restricted Feeding | Intervention Type: BEHAVIORAL; Name: Time Restricted Feeding; Assigned to Arm(s): Time Restricted Feeding
C: Arm Label: Fasting Day First; Type: OTHER; Interventions: Behavioral: Fasting First | Arm Label: Fed Day First; Type: OTHER; Interventions: Behavioral: Fed First | Intervention Type: BEHAVIORAL; Name: Fasting First; Assigned to Arm(s): Fasting Day First | Intervention Type: BEHAVIORAL; Name: Fed First; Assigned to Arm(s): Fed Day First
D: Arm Label: Caloric restriction only; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Caloric restriction only | Arm Label: Caloric restriction plus TRF morning; Type: EXPERIMENTAL; Interventions: Behavioral: Caloric restriction plus TRF morning | Arm Label: Caloric restriction plus TRF night; Type: EXPERIMENTAL; Interventions: Behavioral: Caloric restriction plus TRF night | Intervention Type: BEHAVIORAL; Name: Caloric restriction only; Assigned to Arm(s): Caloric restriction only | Intervention Type: BEHAVIORAL; Name: Caloric restriction plus TRF morning; Assigned to Arm(s): Caloric restriction plus TRF morning | Intervention Type: BEHAVIORAL; Name: Caloric restriction plus TRF night; Assigned to Arm(s): Caloric restriction plus TRF night

Answer: A