Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
NCT ID: NCT05681468
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
175 participants
INTERVENTIONAL
2023-09-18
2026-05-31
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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KETO-Can
KETO diet supplemented with Canola oil (high in MUFA and omega-3 FA).
Keto-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%.
KETO-Sat
KETO diet supplemented with butter and coconut oil (high in SFA).
Keto-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%.
Low fat diet (LFD)
Low fat diet supplemented with whole grain foods (pasta or brown rice) and oatmeal.
LFD
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).
Interventions
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Keto-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%.
Keto-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%.
LFD
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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University of Alberta
OTHER
Responsible Party
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Principal Investigators
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Catherine Chan, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
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University of Alberta
Edmonton, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00123687
Identifier Type: -
Identifier Source: org_study_id
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