None listed
Conditions
Brief summary
Last year we measured the difference in acute blood glucose response due to food where whole grains were either intact, or ground down (ACTRN12617000328370). The differences we observed in blood glucose from these meal responses warrants further investigation, to see if the structural integrity of whole grains may play a role in the longer-term blood glucose control of people with type 2 diabetes. This new trial therefore looks at blood glucose control in two, two-week interventions. We would like the same people to do both interventions, with a two-week break in between the interventions. In one intervention, we will provide participants with whole grain products that are largely intact (whole oats, bread with whole grains baked in, and brown rice) and ask them to replace their grain servings each day with the foods we provide. In the other intervention we will provide whole grain products that have been milled (instant oats, wholemeal bread, pasta made from brown rice) and ask them to replace their grain servings each day with the foods we provide. Each participant will be randomised to the order they do the interventions in. We would like 28 or more participants to complete both interventions. During each intervention participant's blood glucose control will be measured with continuous blood glucose monitors. We will primarily compare participants blood glucose control with these devices between interventions, but we will also consider possible differences in participant satiety, cholesterol and other blood markers, the level of acid forming plaque on their teeth, and measures of body weight and body fatness. Our hypothesis is that the structural integrity of the wholegrain is a necessary parameter of why whole grains have been identified as beneficial in both prospective and intervention studies. Removing the structural integrity of whole grains therefore, will reduce the beneficial response. We are particularly interested in blood glucose control, but will also measure blood lipids and inflammation to see if the structural integrity of whole grains might also influence these other cardiometabolic markers.
Interventions
A two week exposure where wholegrain foods will be provided to participants, where the whole grains are largely intact, which is to say minimally processed. Examples are whole oats, a wholegrain bread with intact grains, and brown rice. Participants completed a pre study four-day dietary record (4DDR) to measure the number of grain serves consumed per day, and were asked to continue consuming that amount from the foods we provided. Adherence with this guideline will be monitored for the two week
A two week exposure where wholegrain foods will be provided to participants, where the whole grains are largely intact, which is to say minimally processed. Examples are whole oats, a wholegrain bread with intact grains, and brown rice. Participants completed a pre study four-day dietary record (4DDR) to measure the number of grain serves consumed per day, and were asked to continue consuming that amount from the foods we provided. Adherence with this guideline will be monitored for the two weeks of the intervention with a daily check list, and with a four day diet record during each two-week exposure. There is a two-week wash out period between the interventions. Blood glucose control will be measured with a continuous glucose monitoring system for the two-week intervention. Participants will receive instructions of how to maintain the device inline with manufacturer recommendations. Previous research by this research group on 41 participants over two interventions did not result in any adverse events due to the use of these devices.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Diagnosed with type 2 diabetes. Have not changed prescribed medicine dose or type in the last three months Willing to comply with study requirements of consuming whole grains each day.
Exclusion criteria
pregnant or lactating.
Outcome results
None listed