Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05681468

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionPreDiabetes, Diabetes Mellitus, Type 2, Overweight and Obesity

Full registry criteria

Inclusion Criteria: * Having overweight or obesity and HbA1C ≥ 5.7% at screening Exclusion Criteria: * 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.

Treatments and study arms

Keto-SAT

Other

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%.

Keto-CAN

Other

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%.

LFD

Other

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).

Primary outcomes

Effect of diets on plasma triglycerides levels by comparing groups at 3 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 3 months).3 months

Assess triglycerides levels collecting blood samples in a fasting state. Triglycerides will be determined using commercially available equipment at a local laboratory (Roche Cobas c503). Measurements will be performed for between group comparison and within groups comparison to understand the effect of diets.

Effect of diets on plasma triglycerides levels by comparing groups at 6 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 6 months).6 months

Effect of diets on LDL-cholesterol levels by comparing groups at 3 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 3 months).3 months

Assess LDL-cholesterol levels collecting blood samples in a fasting state. LDL-Cholesterol levels will be determined using commercially available equipment at a local laboratory (Roche Cobas c503). Measurements will be performed for between group comparison and within groups comparison to understand the effect of diets.

Effect of diets on LDL-cholesterol levels by comparing groups at 6 months of intervention (i.e. control low fat diet and the 2 keto groups) and changes over time within each group (i.e. baseline vs. 6 months).6 months

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Alberta🇨🇦 Edmonton, Alberta, Canada

Open map

Paulina Blanco Cervantes, MScContact

Email · Call 780-492-9506

Catherine Chan, PhDContact

Email · Call 780-492-9939

Catherine Chan, PhDPrincipal Investigator