None listed
Conditions
Brief summary
This study aims to compare the effects of two nut ingestion patterns, vs. no nut intake, on the 24-hour blood glucose homeostasis of adults with type 2 diabetes (T2DM). We hypothesise that nuts, when evenly distributed across three main meals, will result in better blood glucose control over 24 hours than when consumed only with breakfast in individuals with T2DM. We further hypothesise that both nut ingestion patterns will be better than a diet without any nuts.
Interventions
This is a cross-over study and the study will last for 7 days in total as described below
Day 1 (research facility): Placement of CGM and accelerometer
Day 2 (free-living environment): Study Diet 1 (randomised)
Day 3 (free-living environment): Washout (habitual diet)
Day 4 (free-living environment): Study Diet 2 (randomised)
Day 5 (free-living environment): Washout (habitual diet)
Day 6 (free-living environment): Study Diet 3 (randomised)
Day 7 (research facility): Removal of CGM and accelerome
This is a cross-over study and the study will last for 7 days in total as described below Day 1 (research facility): Placement of CGM and accelerometer Day 2 (free-living environment): Study Diet 1 (randomised) Day 3 (free-living environment): Washout (habitual diet) Day 4 (free-living environment): Study Diet 2 (randomised) Day 5 (free-living environment): Washout (habitual diet) Day 6 (free-living environment): Study Diet 3 (randomised) Day 7 (research facility): Removal of CGM and accelerometer This trial consists of 3 Study Diets, which includes a control (no nut) and two intervention diets, which are 1) ONE (1 preload of 42g whole almonds consumed with the first meal i.e. breakfast, and 2) PRE-M (14g whole almonds (total 42g) consumed with each of 3 main meals). Each Study Diet will last for 1 day (on Day 2, 4 and 6), with washout between Study Diets on Day 3 and 5. As part of the study design and to enhance compliance, participants will be provided with all meals on Study Diet days (Day 2, 4 & 6), where meals and intervention foods (weighed whole almonds) will be packed and clearly labelled, so that the participants know when to consume these meals and almonds.
Sponsors
Deakin University
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 No maximum
Healthy volunteers
No
Inclusion criteria
1) age 18 years and over, 2) normal or overweight, 3) diagnosed with T2DM and managed via diet or diabetes medication (but not insulin), 4) no nut allergy, 5) non-regular-nut-consumers (intake <2 times/week)
Exclusion criteria
1) Patients using insulin to control blood sugar levels, and 2) the presence of other illness that affects dietary intake and blood glucose levels, e.g. gastrointestinal disease
Outcome results
None listed