None listed
Conditions
Brief summary
We are undertaking a randomised, placebo-controlled trial of a twice daily protein preload (20 g whey preload mixed with 5 g guar), taken before breakfast and dinner, to test the hypothesis that glycated haemoglobin (HbA1c) will be reduced by at least 0.5% compared to baseline at 12 weeks, in patients with type 2 diabetes who have relatively good glycaemic control (HbA1c less than or equal to 7.9%) on diet or metformin therapy alone. We will also test the secondary hypothesis that the whey preload (i) will induce slowing of gastric emptying, stimulation of incretin hormones and insulin, and reduce appetite and glycaemia after a standardised meal, and that these effects are sustained over 12 weeks; (ii) will induce greater reduction in HbA1c in subjects with more rapid gastric emptying at baseline; (iii) is not associated with weight gain, due to “compensation” for the increased protein load; and (iv) will reduce HbA1c independently of changes in insulin resistance, weight, or body composition.
Interventions
Protein shake containing 20g whey and 5g guar gum, along with flavouring and artificial sweetener, in 150 mL water, taken 15 min twice daily (before their usual morning and evening meal) for 12 weeks. Adherence will be monitored by package counts every two weeks during the intervention and telephone calls on the alternate weeks.
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Type 2 diabetes, managed with diet or metformin alone - HbA1c between 6.0% and 7.9% inclusive - Body mass index 19-40 - Weight stable
Exclusion criteria
- Significant gastrointestinal symptoms, or history of gastrointestinal disease - Proteinuria - Use of medications likely to affect gastrointestinal function
Outcome results
None listed