Authors
»
Queensland University of Technology -More
Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2022
INTERVENTION: The intervention group will be provided with a meal replacement shake consisting of 201kCal of energy, 20.0 g of protein, 4.5 g of fat, and 18.2 g of carbohydrate per serving. The meal replacement will be in powdered form and the subjects will be advised to prepare the liquid shake by mixing 53g of powdered meal replacement with 200 ml of water. They will be asked to consume one serving of the meal replacement shake to replace dinner for 5 days of the week for a period of 8 weeks. They will be given sufficient meal replacement tins with a label indicating the ingredients and the preparation method. Subjects will be instructed not to consume any additional food in between dinner or breakfast. The breakfast and lunch meals will be recommended as normal meals. In addition, participants of the intervention group will be asked to maintain a compliance log by reporting their intake to monitor adherence to the intervention. CONDITION: Diet and Nutrition ‐ Obesity Obesity; ; Obesity Public Health ‐ Epidemiology PRIMARY OUTCOME: The proportion of participants with a minimum 5% reduction in body weight from baseline. ; Body weight will be measured using a calibrated digital weighing scale, Seca 813, Hamburg, Germany) [Body weight will be measured at 3 time points. During the recruitment, at 4th week and at the completion of the study at 8th week. ] SECONDARY OUTCOME: Secondary Outcome 1: ; Other anthropometric measures such as, height, waist circumference (WC), and hip circumference (HC) ; ; Assessment method: ; Height will be taken to the nearest 0.1 cm, as the maximum distance to the uppermost position on the head from heels, using a calibrated stadiometer (Seca 213 portable stadiometer). Body weight will be measured to the nearest 0.1 kg using a calibrated digital weighing scale (Seca 813, Hamburg, Germany). Waist and hip circumferences will be measured using a plastic flexible tape to the nearest 0.1 cm. [Will be measured at recruitment, at 4th week and at the completion of the study at 8th week. ] Secondary Outcome 2: ; Systolic blood pressure (SBP) and diastolic blood pressure (DBP) ; ; Assessment method: ; Seated blood pressure will be recorded to on two occasions after at least a 10‐min rest using a digital blood pressure monitors (Omron Healthcare, Singapore). [Will be measured at recruitment (0 week) and at the end of the study (8 weeks)] Secondary Outcome 3: ; Lipid profile (total cholesterol, LDL, HDL and TAG). ; ; Assessment method: ; Will be assessed by blood tests. A venous blood sample of 10‐12 ml will be collected from each participant after an overnight fasting. Serum glucose, total cholesterol, triglycerides, and HDL cholesterol were determined using a Cobas c501 auto analyzer using an electrochemiluminescent immunoassay (ECLIA, Roche Diagnostics). [Will be measured at recruitment (0 week) and at the end of the study (8 weeks)] Secondary Outcome 4: ; Glycemic control measures (FBS, HbA1c) ; ; Assessment method: ; Assessed by blood test[Will be measured at recruitment (0 week) and at the end of the study (8 weeks)] Secondary Outcome 5: ; Body composition parameters ; ; Assessment method:: ; Will be assessed using a bio‐electrical impedance analyser (Bodystat, Douglas, Isle of Men, UK). [Will be measured at recruitment (0 week) and at the end of the study (8 weeks)] INCLUSION CRITERIA: a) Permanent employees aged 18‐60 years b) Have been working shifts continuously for past 12 months and continue during whole study period which is 8 weeks c) Working at least 3 night shifts/week d) Participants with BMI >27.5 kg/m2 e) Not having any allergies to any of the known food ingredients in the meal replacement
Epistemonikos ID: 7587eb96022794e7eaaa559574f7e795a53b8c98
First added on: Aug 25, 2024