Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Alberta
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Having overweight or obesity and HbA1C ≥ 5.7% at screening
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Keto-SAT
Other interventionNutrition 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 interventionNutrition 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 interventionNutrition 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).
Treatment groups
175 Participants
are divided into 3 treatment groupsGroup A: KETO-CanExperimental treatment 1 intervention
Group B: KETO-SatExperimental treatment 1 intervention
Group C: Low fat diet (LFD)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
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.
Time frame
3 months2
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).
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.
Time frame
6 months3
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).
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.
Time frame
3 months4
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).
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.
Time frame
6 monthsSecondary outcomes
1
Effect of diets on blood glucose 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).
Assess blood glucose levels collecting blood samples in a fasting state. Blood glucose 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.
Time frame
3 months2
Effect of diets on blood glucose 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).
Assess blood glucose levels collecting blood samples in a fasting state. Blood glucose 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.
Time frame
6 months3
Effect of diets on insulin 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).
Assess insulin levels collecting blood samples in a fasting state. Insulin levels will be determined using commercially available equipment at a local laboratory (Roche Cobas e801). Measurements will be performed for between group comparison and within groups comparison to understand the effect of diets.
Time frame
3 months4
Effect of diets on insulin 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).
Assess insulin levels collecting blood samples in a fasting state. Insulin levels will be determined using commercially available equipment at a local laboratory (Roche Cobas e801). Measurements will be performed for between group comparison and within groups comparison to understand the effect of diets.
Time frame
6 monthsOther outcomes
1
Adherence to diet interventions using 24-hour dietary assessment tool
A validated online 24-recall questionnaire (ASA24) will be administered to participants to assess adherence to diets every month.
Time frame
4 weeks2
Change in fatty acid composition to confirm adherence to the diets at 3 months
Total lipids in plasma, RBCs and PBMCs membranes will be extracted using Folch ratio 4:1 (chloroform:methanol (2:1): KCl). Extracted lipids are then methylated to create fatty acid methyl esters which will be measured by automated gas chromatography using an agilent 7890/8890 GC with a 100m CP-Sil 88 fused capillary column for long chain fatty acids. Total phospholipids and lipid classes in PBMCs membrane will be quantified using thin-layer chromatography and identified using internal standards.
Time frame
3 months3
Change in fatty acid composition to confirm adherence to the diets at 6 months
Total lipids in plasma, RBCs and PBMCs membranes will be extracted using Folch ratio 4:1 (chloroform:methanol (2:1): KCl). Extracted lipids are then methylated to create fatty acid methyl esters which will be measured by automated gas chromatography using an agilent 7890/8890 GC with a 100m CP-Sil 88 fused capillary column for long chain fatty acids. Total phospholipids and lipid classes in PBMCs membrane will be quantified using thin-layer chromatography and identified using internal standards.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov