None listed
Conditions
Brief summary
This project aims to investigate if having a meal replacement product for dinner during night shift days is an effective strategy to achieve a body weight loss in shift workers with obesity compared to a conventional dinner. The research will be a parallel, randomized controlled clinical trial and will be conducted at the Nawaloka Hospital PLC, Colombo, Sri Lanka. The participants will be the shift working hospital staff with obesity. The treatment group will receive 5 meal replacement dinner meals per week. The control group will have their regular dinner meal. In addition, both groups will be given lifestyle advices and basic dietary advices according to Sri Lankan food based dietary guidelines. The study will be conducted for a period of 8 weeks and the evaluations of anthropometric and biochemical parameters will be done at the beginning, at the 4th week, and at the end of the 8th week of the study. The hypothesis being tested in this trial is to improve the metabolic parameters in the intervention group by achieving a minimum of 5% body weight loss. Please refer to the attached protocol for further details
Interventions
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 g
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.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
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
Exclusion criteria
a) Pregnant or lactating mothers b) Having known chronic disease conditions c) History of any type of minor or major surgical procedure in the past 6 months. d) Currently on diet prescriptions or participating regular physical activity sessions/programs ( e.g. yoga class)
Outcome results
None listed