None listed
Conditions
Brief summary
Diet and lifestyle change are key elements of the management of blood sugar levels and blood pressure in those with type 2 diabetes. There is growing evidence that foods containing lupin could make a positive contribution to management of diabetes. Lupin can be used as a novel food ingredient. It is rich in protein and fibre and contains negligible sugar and starch (glycaemic carbohydrate). It can be incorporated into foods such as bread to reduce the glycaemic (blood sugar raising) carbohydrate. We will conduct an intervention study in type 2 diabetic subjects to investigate the effects of regular consumption of lupin-containing foods on short-term control of blood sugar levels, blood pressure and attention and memory.
Interventions
A randomised, controlled, cross-over designed trial will be performed to investigate the short-term effects of regular consumption of lupin-containing food (bread, breakfast cereral, pasta and crumbs) on glycaemic control (primary outcome), blood pressure, attention and working memory in type 2 diabetic individuals. A study coordinator and research nurse with experience in the conduct of similar nutrition intervention studies will be responsible for the conduct of the study.
Participants will
A randomised, controlled, cross-over designed trial will be performed to investigate the short-term effects of regular consumption of lupin-containing food (bread, breakfast cereral, pasta and crumbs) on glycaemic control (primary outcome), blood pressure, attention and working memory in type 2 diabetic individuals. A study coordinator and research nurse with experience in the conduct of similar nutrition intervention studies will be responsible for the conduct of the study. Participants will be randomly assigned with the use of computer-generated random numbers to 1 of 2 groups: control then lupin or lupin then control. Both lupin and control participants will be required to replace ~15–20% of their usual daily energy intake from wheat-based products, with either control or lupin foods, for 8 weeks each. The two 8-week intervention periods will be separated by an 8-week washout period where participants return to their usual diet. Throughout the entire study period alcohol intake, physical activity and medication will be maintained as usual. The food, for both the lupin and control foods will be provided. Compliance to diets will be monitored using questionnaires and return of unused foods at biweekly study visits. With the inclusion of several lupin enriched foods and matching control foods, there will be only minor changes to the make-up of the diet (the types of foods consumed).
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Men and women 40 to 70 years old with moderate to well-controlled type 2 diabetes (glycated Hb < 9%) will be recruited from the general population. The diagnosis of diabetes will be confirmed by either a fasting serum glucose >7 mmol/l, the participant’s registration with the National Diabetes Services Scheme (which requires a medical diagnosis of diabetes), use of metformin, or confirmation from the participant’s general practitioner (with a review of relevant clinical data).
Exclusion criteria
Exclusion criteria will include type 1 diabetes; duration of diabetes >10 years; use of insulin; glycated Hb >9%; change in body weight >10% in the previous 6 months; BMI > 35 kg/m2; cigarette use in the previous 6 months; daily ethanol consumption >20 g for females or >30 g for males; known allergy to lupin, nuts, soya, dairy, wheat or gluten; don’t regularly consume bread; other major chronic illness; change in regular prescription medications in the previous 3 months; estimated usual intake of bread and related wheat-based baked products of less than 100 g/d; and inability or unwillingness to follow the study protocol.
Outcome results
None listed