None listed
Conditions
Interventions
Overweight subjects with type 2 diabetes will be randomized to either a generic weight loss advice group or they will be randomized to a meal replacement group.The weight loss advice group will be attending a group information session at the start of the study. That group will be asked to follow that advice for 12 months.The meal replacement group will consume 2 meal replacements/day until a weight loss of 10% is achieved and will then switch to one meal replacement/day, for a total trial dura
Overweight subjects with type 2 diabetes will be randomized to either a generic weight loss advice group or they will be randomized to a meal replacement group.The weight loss advice group will be attending a group information session at the start of the study. That group will be asked to follow that advice for 12 months.The meal replacement group will consume 2 meal replacements/day until a weight loss of 10% is achieved and will then switch to one meal replacement/day, for a total trial duration of 12 months.The product will be manufactured by Probiotec..
Sponsors
Probiotec Limited
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Body Mass Index greater than27. Weight limit of 130kg. Type 2 diabetes diet controlled, on oral hypoglycaemic medication or on insulin. HbA1c less than 9%
Exclusion criteria
Known lactose intolerance or dairy allergy . Participation in a study within 30 days of commencement of the study. Weight changes of more than 3kg over last 3 months. Taking any medications which may interfere with study parameters. Untreated hypertension Systolic Blood Pressure more than 150 mmHg. Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions.
Outcome results
None listed