None listed
Conditions
Brief summary
This is a randomised crossover trial with two interventions lasting two weeks, separated by a washout period of at least two weeks where bread is provided to participants. We aim to determine if maximum fortification of a commonly consumed food (bread) with fibre and protein influence established cardiometabolic risk factors, microbiome profile and functionality in adults with type 2 diabetes when compared with a bread not fortified with fibre and protein. For the more novel microbiome and metabolite data we will employ machine learning to better understand the complex interplay between dietary change towards higher fibre and protein intakes on microbiome profile, metabolite signature, and host cardiometabolic risk factors.
Interventions
In the active intervention, a maximally fortified bread high in fibre (14.5g per 100g) and protein (26g per 100g) will be provided to participants, and they will be advised to replace the bread they normally consume with the bread we provide for periods of two weeks. No minimum amount of bread intake will be required from participants. Adherence to this intervention will be monitored for the two weeks of the intervention with a four-day diet record and biomarkers of food intake from plasma sampl
In the active intervention, a maximally fortified bread high in fibre (14.5g per 100g) and protein (26g per 100g) will be provided to participants, and they will be advised to replace the bread they normally consume with the bread we provide for periods of two weeks. No minimum amount of bread intake will be required from participants. Adherence to this intervention will be monitored for the two weeks of the intervention with a four-day diet record and biomarkers of food intake from plasma sample. This intervention is separated to the other intervention by a washout period of at least two weeks.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Participants will be aged 18-80 years and have been diagnosed with type 2 diabetes. Participants will have kept their diabetes-related prescribed medication stable for the last three months, and must be willing to comply with the study requirement to consume the provided bread.
Exclusion criteria
Current pregnancy or lactation will exclude participation, as well coeliac disease or any health condition that would require participants to avoid bread intake. A change in type or dose of diabetes medication in the past three months.
Outcome results
None listed