Watson N, Dyer K, et al. 2016

27187457

Effects of Low-Fat Diets Differing in Protein and Carbohydrate Content on Cardiometabolic Risk Factors during Weight Loss and Weight Maintenance in Obese Adults with Type 2 Diabetes.

Watson N, Dyer K, Buckley J, Brinkworth G, Coates A, Parfitt G, Howe P, Noakes M, Murphy K

Nutrients

2016

8

5

Randomized Controlled Trial

Some concerns

Diagnosed with T2DM; aged 18-70 years; HbA1c between 6.5-10.5% at screening; BMI greater than 25 kg/m2; weight < 135kg (maximum capacity for dual X-ray absorptiometry [DEXA]); non-smoker for more than 6 months; proficient in written and spoken English (to perform the cognitive tests); age-appropriate cognitive abilities (determined using the DemTect questionnaire); completion of a questionnaire requesting information on current disease management, medical conditions, medications, weight, smoking status, dietary requirements and ability to exercise; Participation approved by personal medical provider; written informed consent.

Liver, kidney, gastrointestinal or cardiovascular disease; respiratory disease (apart from stable asthma); retinopathy; malignancy (within last 6 months); proteinuria; uncontrolled hypertension (>170/100); taking medication for a neurological or psychiatric condition (except stable antidepressants > 3 months); neurological or psychiatric condition; history of head or brain injury; musculoskeletal injury or peripheral vascular disease sufficient to impede exercise; undertaking a weight loss program or taking appetite suppressants; pregnant or lactating; unable to participate in the trial for 6 months; participated in another study within last 30 days.

To compare the effects of isocaloric higher protein (HP) and higher carbohydrate (HC) diets, combined with regular moderate intensity exercise, on glycaemic control and cardiometabolic risk factors in overweight and obese adults with type 2 diabetes mellitus (T2DM) initially following 12 weeks of active weight loss, and then to re-evaluate the outcomes following 12 weeks of energy balance without the influence of weight change.

An investigator with no participant contact allocated participants to intervention using the process of minimization stratified by age, gender and BMI.

Adelaide, Australia

Government, Industry

Pork Cooperative Research Centre; food donations: Australian Health and Nutrition Association Ltd (Sanitarium), Fonterra Brands Australia, The Almond Board of Australia.