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

Plain Language Summary

Simplified for easier understanding

This study is comparing two versions of a ketogenic (very low-carb, high-fat) diet — one emphasizing saturated fats and one emphasizing unsaturated fats — to see how each affects blood sugar, inflammation, and metabolic health in people who are overweight or obese with elevated blood sugar. **You may be eligible if...** - You have overweight or obesity - Your HbA1c (a blood sugar measure) is 5.7% or higher at screening, indicating prediabetes or early diabetes **You may NOT be eligible if...** - You follow a specific diet that would prevent you from following the study's nutritional plan - You are pregnant - You are on dialysis or have been told to follow a low-protein diet - You have familial high cholesterol or high triglycerides - You are a transgender individual currently transitioning - You have other unstable health conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).