None listed
Conditions
Brief summary
The aim of this study is to compare glycaemic control with 50, 90 and 130 g carbohydrates per day in people with type 2 diabetes and to test whether a 90g carbohydrate reduction is enough to improve time in range (3.9-10 mmol/L) and decrease time above range (>10 mmol/L) compared to the commonly used lower carbohydrate definitions of 50g and 130g carbohydrates per day for the management and treatment of T2D (hyperglycaemia) through diet.
Interventions
This randomised crossover control trial will have a usual dietary intake period of 1-weeks followed by three 1-week intervention protocols assigned in random order; 50g per day total carbohydrate intake, 90g per day total carbohydrate intake and 130g per day total carbohydrate intake. Protein intake will remain constant and fat intake will be adjusted accordingly to ensure each arm is isoenergetic. There will be at least 1 week washout period between conditions.
Participants will receive a reci
This randomised crossover control trial will have a usual dietary intake period of 1-weeks followed by three 1-week intervention protocols assigned in random order; 50g per day total carbohydrate intake, 90g per day total carbohydrate intake and 130g per day total carbohydrate intake. Protein intake will remain constant and fat intake will be adjusted accordingly to ensure each arm is isoenergetic. There will be at least 1 week washout period between conditions. Participants will receive a recipe book and a $600 grocery voucher. Sample meal plans will be provided and individual diets tailored during a 1-hour consultation with a dietitian (either face-to face or via telehealth) at the start of each intervention. A weekly scheduled e-mail/phone call check in will be available for participants, as well as unlimited email contact with the study dietitian as needed. Scales will be provided to assist participants accurately measure food and beverage quantity. To control for weight-loss, the Mifflin equation will be used to estimate the daily energy requirement for each participant. Weight will be recorded at baseline and again following each 2-week intervention period. Caloric intake will be adjusted as needed prior to commencing the next intervention. The app Easy Diet Diary will be used to self-report daily intake as an adherence measure, along with weekly check-ins with the dietitian
Sponsors
University of Wollongong
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Aged between 30 and 70 years Formal diagnosis of type 2 diabetes Current HbA1c 6.5-9% Stable medication and weight for previous 3 months
Exclusion criteria
Non-English speakers severe kidney or liver diseases undergoing treatment for cancer Previous bariatric surgery Insulin or sulfonylureas Pregnancy and breastfeeding Food allergies or aversions that may prevent participation, to be evaluated on a case-by-case basis
Outcome results
None listed