RecruitingNot ApplicableNCT05681468

Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources

Sponsor

University of Alberta

Enrollment

175 participants

Start Date

Sep 18, 2023

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Prediabetes Overweight and Obesity

Summary

The goal of this clinical trial is to compare a healthy KETO diet supplemented with canola oil (KETO-Can) compared to a traditional KETO diet high in saturated fat (KETO-Sat) and low-fat diet (LFD) in adults at high risk of or diagnosed with type 2 diabetes. The main question\[s\] it aims to answer are: * Effects on CVD risk factors (plasma cholesterol, TG, ApoB100, glucose, insulin and HbA1C). * Effects on systemic inflammation and immune function. * Adherence to interventions. Participants will be randomized into 1 of the dietary treatments during which they will follow a Keto or a low-fat diet. Comparisons among groups at 3 and 6 months of intervention will be conducted.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

Having overweight or obesity and HbA1C ≥ 5.7% at screening

Exclusion Criteria6

Individuals with specific nutritional habits preventing them from adhering to nutritional recommendations
Pregnant women
People on dialysis or recommended to follow a low-protein diet (base on glomerular filtration rate)
Familial hypercholesterolemia or hypertriglyceridemia
Transitioning trans-gender
For safety purposes, other individuals would be excluded if are under unstable health conditions.

Interventions

OTHERKeto-SAT

Nutrition counselling focused on Keto diet (saturated fat). 10% TE as carbohydrate (mainly from vegetables and whole grain products), protein between 20-30% TE and fat between 60-70%.

OTHERKeto-CAN

Nutrition counselling focused on Keto diet (unsaturated fat). 10% TE as carbohydrate (mainly from vegetables and whole grain products), protein between 20-30% TE and fat between 60-70%.

OTHERLFD

Nutrition counselling focused on low-fat diet. 30% total energy (TE) as fat, 50% TE as carbohydrates (primarily whole grains) and 17-20% TE protein (mainly lean sources).