None listed
Conditions
Brief summary
There is almost universal acceptance that appropriate nutrition is a pivotal component of attempts to reduce the burden of disease such as obesity, diabetes, cardiovascular disease and some cancers. Healthy eating also has the potential to help achieve equity of health outcomes amongst population groups where inequalities exist such as Maori and Pacific people in New Zealand. While some dietary advice is generally accepted, there is continuing debate regarding the amount and type of dietary carbohydrate. There is convincing evidence that wholegrain consumption protects against colorectal cancer, type 2 diabetes and cardiovascular disease. Whole grains products are recommended in New Zealand and abroad in dietary guidelines however current definitions make no mention of fibre structure and particle size, referring only to grain constituents. Given that an increasing number of relatively refined wholegrain products (as presently defined) are now appearing on supermarket shelves, the potential effect of wholegrain particle size must be considered. Wholegrain foods consumed today are very different from those available several decades ago in the prospective studies where the benefit of whole grains were clearly demonstrated, however the health effects of this additional food processing are largely unknown. We have previously considered the acute (HDEC Ethics 17/STH/41) and short-term (HDEC Ethics 18/STH/172) role of wholegrain structure in blood glucose response. We will now consider the role of wholegrain structural integrity on a long-term marker of blood glucose management of adults with type 2 diabetes (glycated haemoglobin or HbA1c).
Interventions
Unmilled wholegrain intervention: We will provide a free delivery of unmilled wholegrain foods delivered to the participants door each fortnight for 12 weeks. Examples are 1kg whole oats, five loaves of 700g wholegrain bread with intact grains, and 1kg brown rice. We will advice participants to replace the grain foods that they normally consume with the wholegrain foods provided. In line with New Zealand dietary guidelines we will not set a maximum number of serves of whole grain per day. There
Unmilled wholegrain intervention: We will provide a free delivery of unmilled wholegrain foods delivered to the participants door each fortnight for 12 weeks. Examples are 1kg whole oats, five loaves of 700g wholegrain bread with intact grains, and 1kg brown rice. We will advice participants to replace the grain foods that they normally consume with the wholegrain foods provided. In line with New Zealand dietary guidelines we will not set a maximum number of serves of whole grain per day. There is no other lifestyle advice given. Intervention adherence will be assessed by Food Frequency Questionnaire, four day food diary, and alkylresorcinols as a metabolite measure of wholegrain intake from a dried blood spot pre and post intervention. All participants continue to receive usual care through their general practice during the study, which may include pharmacological and lifestyle management.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Participants will be aged 18-80 and have been diagnosed with type 2 diabetes. Participants must be willing to comply with the study requirement to replace the grain foods they eat with the provided wholegrain foods.
Exclusion criteria
Participants will have not changed prescribed diabetes medicine dose or type in the last three months.
Outcome results
None listed