Please select the outcome measures that correspond 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: Change in Total Body Weight (in kg) at 3 months compared to baseline (Baseline to 3 months)
B: Endothelium Dependent Dilation (6 weeks)
C: Change From Baseline in Participant Glucose When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Insulin When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Adiponectin When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Hemoglobin When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Hematocrit When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Platelet Count When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Bicarbonate When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Sodium When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Chloride When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Calcium When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Potassium When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Creatinine When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Triglycerides When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Weight When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Waist Circumference When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed (Baseline and 3 days)
D: Change in body weight (Baseline and weeks 2, 4 and 8)

Answer: A