CRDA: Inflammatory Marker Outcomes (2023)

Author and Year:
Watson N, Dyer K, et al. 2016
PubMed ID:
Article Title:
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
Year of publication:
Page numbers:
Study Design:
Randomized Controlled Trial
Risk of Bias Assessment Rating:
Some concerns
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Research Purpose:
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.
Blinding efforts:
An investigator with no participant contact allocated participants to intervention using the process of minimization stratified by age, gender and BMI.
Study Location:
Adelaide, Australia
Source(s) of Funding:
Government, Industry
Please specify names of funders:
Pork Cooperative Research Centre; food donations: Australian Health and Nutrition Association Ltd (Sanitarium), Fonterra Brands Australia, The Almond Board of Australia.