The ketogenic diet (KETO) is popular for weight loss and is gaining interest as a
treatment for type 2 diabetes (T2D) because it is believed to help manage blood glucose
and weight. However, KETO is often high in saturated fats (SFA), which may increase
cholesterol and other cardiovascular (CVD) risk factors, such as inflammatory profile.
Substituting a heart-healthy oil for SFA may improve these outcomes.
The purpose of our study is to investigate the health beneficial effects of a healthy
KETO diet supplemented with Canola oil, compared to a traditional Keto Diet and low-fat
diet in adults at high risk of type 2 diabetes. Participants will be randomized to one of
these three diets and will receive nutrition counselling during 6 months.
Each month, participants will receive a 1-month supply of canola oil in the KETO-Can
group, butter and coconut oil in the KETO-Sat group and whole grain foods (pasta or brown
rice) and oatmeal in the LFD group to ensure compliance to key nutrients.
Fasting blood samples will be taken at baseline, 3 and 6 months. Anthropometric
measurements (weight (BW), waist circumference (WC), BMI), blood pressure (BP), systemic
inflammation (CRP, IL-6, TNF-α, IL-18), immune function, cardiometabolic risk factors
(TG, cholesterol, glucose, insulin and HbA1C) will be determined at each time point.
A total of three 24h-recall questionnaires (2 weekdays and 1 weekend day) will be
completed at each time point (baseline, 3 months, 6 months). Once a month (in between
study visits) a 24h-recall will be completed before meeting the nutrition expert in order
to personalize recommendations according to participants' respective diet groups.
As in any nutritional study, adherence for nutrition study is a key factor and will be
measured differently during the intervention. Menu examples will be provided for each
group to facilitate adherence. Adherence to the study protocol will be assessed by (1)
evaluation of 24-h recall data (14 in total). Participants with 11 out of 14 recalls
being within meeting dietary objectives will be considered highly compliant, 6 or less
would be low compliance; (2) Ketosis state will be measured at each study visit using
ketone strips to assess adherence to both KETO diets; (3) Participants will be asked to
report the food consumed each month to determine the level of consumption. Finally, fatty
acid composition in plasma (short-term) and red blood cells (RBCs; reflect the past 3
months) will be assessed to confirm adherence between the two keto diets.
