None listed
Conditions
Brief summary
In a 6 month dietary intervention trial, we aim to compare the effects of an energy restricted low carbohydrate/high protein diet and an energy restricted high carbohydrate/low protein diet with regular moderately intense aerobic exercise on glycemic control in individuals with type 2 diabetes. Assessing weight loss and weight maintenance, cardiometabolic health (blood pressure/cholesterol/C-reactive protein/insulin/glucose), food cravings, cognitive performance, psychological wellbeing and quality of life. We believe the low carbohydrate/high protein diet will give the greatest improvements in these outcomes.
Interventions
High Protein/Low Carbohydrate diet (containing 30% total dietary energy from protein) for 6 months, consisting of an Energy Restriction (weight loss) phase of 3 months, followed by an Energy Balance (weight maintenance) phase of 3 months. Combined with moderately intense aerobic exercise.
The dietary pattern will be prepared in accordance with the Australian Guide to Healthy Eating and will be a balanced diet consisting of all food groups.
30% Dietary energy will come from protein. Predomiant
High Protein/Low Carbohydrate diet (containing 30% total dietary energy from protein) for 6 months, consisting of an Energy Restriction (weight loss) phase of 3 months, followed by an Energy Balance (weight maintenance) phase of 3 months. Combined with moderately intense aerobic exercise. The dietary pattern will be prepared in accordance with the Australian Guide to Healthy Eating and will be a balanced diet consisting of all food groups. 30% Dietary energy will come from protein. Predomiant protein sources will be meat (pork, beef, chicken) as well as fish, dairy and plant sources (legumes and pulses) To acheive weight loss, dietary energy will be restircted by 20-30% (approximately 2000-4000KJ per day) and each individual will have their diet tailored by a dietician based on energy requirements, gender and BMI. After 3months weight loss, each individuals dietary energy will be adjusted by the dietician to maintain the weight loss to date for a further 3months. Moderately intense excerise will be required 5x per week for 30minutes. Walking, Jogging or Running depending on individual choice will be undertaken. Volunteers may conduct their activity alone or join walking groups that will be offered around the Adelaide CBD. Excercise will be perceptually-regulated at a Rating of Perceived Exertion (RPE-13) that is perceived to be "somewhat hard" which results in moderately instese aerobic exercise.
Sponsors
Prof Jon Buckley (Centre Director)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Poorly controlled type 2 diabetes (with a HbA1c level between 7-10%); overweight or obese (BMI, 25 kg/m2 and above); omnivorous; English as a First Language (different cognitive processes are applied when learning words from a non-native language)
Exclusion criteria
Subjects who report one of the following: known proteinuria, malignancy; liver, kidney, cardiovascular, respiratory, or gastrointestinal disease; uncontrolled hypertension; previous stroke; pregnancy or lactating; smoker (or smoking in the last 6months); musculoskeletal injury or joint or peripheral vascular disease sufficient to impede exercise; use of appetite suppressants or Orlistat (Xenical); retinopathy; inability to consume a high meat protein diet for 6 months; actively undertaking a weight loss program or report their weight is greater than 135kg (exceeds the capability for DEXA scanning to assess body composition); unable to participate in the trial for 6 months; taking medications for, or had a history of head/brain, neurological or psychiatric conditions, scores of <13 on the DemTect indicating mild cognitive impairment or dementia will be excluded.
Outcome results
None listed