None listed
Conditions
Brief summary
The aim of this research is to test if participant retention in a commercially available meal replacement program (MRP; Impromy) is improved when the standard Impromy program is modified to enhance weight loss. Enhanced weight loss will be expected by incorporating 3 days per week of ‘additional calorie restriction’ and one day of ‘free eating’ per week, over 16 weeks. Impromy is a weight loss program developed in partnership with CSIRO, and validated by CSIRO. It is commercially available through pharmacies across Australia. The current program consists of an energy restricted weight loss diet that includes meal replacements, personalised support from trained pharmacy assistants and a phone application for additional support and monitoring. The outcomes of this study will inform development of the Impromy program with the goal of improving program retention and therefore overall weight loss. A second aim of this study is to investigate how the two dietary protocols affect , or are affected by: 1.Biological indicators of health, including changes in body fat and muscle, blood glucose and cholesterol levels, blood pressure, nutrient status, gut health and the gut bacteria, genetic & blood and buccal cell epigenetic markers and novel markers of metabolic health (including retinal vascularity). 2.Eating behaviours and food craving, well being, psychological outcomes, perceived health, cognitive function and gut comfort.
Interventions
Modified Meal Replacement Program (M-MRP):
The M-MRP group will alternate between MF (3 days/week; Monday, Wednesday, Friday) and the Standard-MRP (3 days/week; Tuesday, Thursday, Sunday), with one day where participants can eat freely, i.e. ad libitum (Saturday). On the MF days, participants will consume 2 Impromy meal replacement shakes (1000kJ each) and a ‘meal’ of free vegetables. Participants will follow this intervention for 16 weeks. Compliance will be collected in week 1, 4, 8, 12, 16 u
Modified Meal Replacement Program (M-MRP): The M-MRP group will alternate between MF (3 days/week; Monday, Wednesday, Friday) and the Standard-MRP (3 days/week; Tuesday, Thursday, Sunday), with one day where participants can eat freely, i.e. ad libitum (Saturday). On the MF days, participants will consume 2 Impromy meal replacement shakes (1000kJ each) and a ‘meal’ of free vegetables. Participants will follow this intervention for 16 weeks. Compliance will be collected in week 1, 4, 8, 12, 16 using 7-day checklists. Participants will be required to mark yes/no to consumption of the allocated number of meal replacements, snacks, evening meal and the approximate number of cups (to the nearest half cup) of free vegetables consumed. Intake on the ad libitum day will not be assessed. Qualified research dietitians will deliver face to face instructions and support at baseline, week 1 (via telephone) 2,4,6,8,10,12, and 14. All participants will then be instructed by the study dietitians to follow an 8 week weight maintenance program based on the Live Well Plan (http://www.beefandlamb.com.au/Learn/Online_magazines/The_Live_Well_Plan).
Sponsors
CSIRO
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1.Adults with a BMI greater than or equal to 27kg/m2; 2.Aged 25-60 years; 3.Willing to attend CSIRO SAHMRI clinic in Adelaide on 10 occasions; 4.Willing to participate in the study including collection of blood samples on 2 occasions, and completing questionnaires, 5.Willing to follow a weight loss dietary protocol for 16 weeks plus weight maintenance dietary protocol a further 8 weeks; 6. Non-smoker; 7. Has been weight stable (i.e. less than 3 kg weight loss) for the past 2 months.
Exclusion criteria
1. Any known pre-existing, diagnosed medical condition (assessed by self report in the screening medical questionnaire) that may prevent them from participating in the study, including but not limited to: a. Kidney disease or renal impairment; b. Gall bladder disorders or stones; 2.Regular use of prescribed weight loss medications; or medications that contain Mono-amine oxidase inhibitors, Lithium, Anticoagulants e.g. Warfarin. 3.Regular use of any other medications prescribed by a medical practitioner that are deemed unsuitable for this trial – as determined by the appointed study physician during screening process; 4.A food allergy/intolerance to, or not willing to consume, the foods prescribed in the protocol; 5.A score of greater than or equal to 2 on the SCOFF screening questionnaire for eating disorders*; 6.A person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol; 7.Women who are attempting to become pregnant, pregnant, lactating, (postmenopausal women should not change HRT regimen during the study); 8.Participation in another study within 30 days of commencement of the present study. a.Liver disease (e.g. cirrhosis); b.Angina, chest pain (undiagnosed) or severe shortness of breath; c.Diagnosed cardiovascular disease; d.Cardiac arrhythmia, heart disease, heart attack, coronary bypass surgery; e.Stroke; f.Dementia; g.Thyroid disease; h.Gout; i.Gastrointestinal disease (including celiac or malabsorption diseases Crohns disease); j.History of bariatric surgery; k.Epilepsy; l.Neurological or psychiatric conditions; m.Severe depression; n.Cancer (unless benign or non-progressive skin cancer); o.Type 1 or type 2 diabetes.
Outcome results
None listed