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This 2018 trial, funded by Virta Health, tested the impact of a high-compliance ketogenic diet on atherosclerotic biomarkers in Type 2 diabetics.
\n
Atherogenic dyslipidemia refers to a particular lipoprotein pattern that has been linked to cardiovascular disease. Key biomarkers include high triglycerides, low HDL-C, and an increased concentration of small LDL particles (i.e., high small LDL-P). This pattern is prevalent in patients with Type 2 diabetes, which suggests many diabetic patients are at higher cardiovascular disease risk than traditional risk markers (i.e., LDL-C) would indicate.
\n
Carbohydrate restriction has been shown to consistently resolve atherogenic dyslipidemia. However, as noted in other Virta-funded studies, the pragmatic value of carbohydrate restriction, and especially of the severe carbohydrate restriction required for a ketogenic diet, is limited by the fact that compliance with ketogenic diets in free-living (i.e., real-world) populations is low. This trial was designed to overcome this compliance issue and directly test the impact of a ketogenic diet, followed properly over a year, on markers of cardiovascular disease.
\n
In this trial, 262 Type 2 diabetics were counseled to follow a diet that would achieve and sustain nutritional ketosis (i.e., blood BHB of 0.5 – 3.0 mmol/L). Each subject was given personalized, dynamic dietary guidance by a health coach who continuously communicated with each subject and tracked biomarkers via an app. As such, the specific diet varied by subject but generally involved 1.5 g/kg of protein intake and <30 g of carbohydrate intake per day, alongside non-starchy vegetables, multivitamins, and adequate fluids. There was no deliberate caloric restriction. Of the original 262 subjects, 218 completed one year of treatment.
\n
A wide variety of atherosclerosis biomarkers were tracked. Selected changes included (all figures refer to mean reductions; all listed changes were statistically significant):
\n
\n
24.4% decrease in triglycerides
\n
18.1% increase in HDL-C (and a -29.1% decrease in HDL-C/triglyceride ratio)
\n
38.9% decrease in large VLDL particle number and 20.8% decrease in small LDL particle number
\n
9.9% increase in LDL-C
\n
4.8% decrease in systolic blood pressure and 4.3% decrease in diastolic blood pressure
\n
39.3% reduction in hsCRP (a marker of inflammation)
\n
\n
There were no significant changes in total LDL particle number or ApoB.
\n
Taken collectively, this trial demonstrated that one year of compliance with a ketogenic diet led to a variety of shifts in subjects’ lipid profiles. With the exception of an increase in LDL-C, all other shifts showed either a neutral or beneficial effect on overall cardiovascular risk. The simultaneous decreases in inflammation (i.e., a 39% reduction in hsCRP) and blood pressure further support a decrease in cardiovascular risk.
\n
Note: The authors noted that a small number of participants (<1%) experienced adverse effects related to cardiovascular risk as assessed by lipid profile changes, which suggests that subjects should be monitored while following a ketogenic diet.
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Cardiovascular Disease Risk Factor Responses to a Type 2 Diabetes Care Model Including Nutritional Ketosis Induced by Sustained Carbohydrate Restriction at 1 Year
This 2018 trial, funded by Virta Health, tested the impact of a high-compliance ketogenic diet on atherosclerotic biomarkers in Type 2 diabetics.
Atherogenic dyslipidemia refers to a particular lipoprotein pattern that has been linked to cardiovascular disease. Key biomarkers include high triglycerides, low HDL-C, and an increased concentration of small LDL particles (i.e., high small LDL-P). This pattern is prevalent in patients with Type 2 diabetes, which suggests many diabetic patients are at higher cardiovascular disease risk than traditional risk markers (i.e., LDL-C) would indicate.
Carbohydrate restriction has been shown to consistently resolve atherogenic dyslipidemia. However, as noted in other Virta-funded studies, the pragmatic value of carbohydrate restriction, and especially of the severe carbohydrate restriction required for a ketogenic diet, is limited by the fact that compliance with ketogenic diets in free-living (i.e., real-world) populations is low. This trial was designed to overcome this compliance issue and directly test the impact of a ketogenic diet, followed properly over a year, on markers of cardiovascular disease.
In this trial, 262 Type 2 diabetics were counseled to follow a diet that would achieve and sustain nutritional ketosis (i.e., blood BHB of 0.5 – 3.0 mmol/L). Each subject was given personalized, dynamic dietary guidance by a health coach who continuously communicated with each subject and tracked biomarkers via an app. As such, the specific diet varied by subject but generally involved 1.5 g/kg of protein intake and <30 g of carbohydrate intake per day, alongside non-starchy vegetables, multivitamins, and adequate fluids. There was no deliberate caloric restriction. Of the original 262 subjects, 218 completed one year of treatment.
A wide variety of atherosclerosis biomarkers were tracked. Selected changes included (all figures refer to mean reductions; all listed changes were statistically significant):
24.4% decrease in triglycerides
18.1% increase in HDL-C (and a -29.1% decrease in HDL-C/triglyceride ratio)
38.9% decrease in large VLDL particle number and 20.8% decrease in small LDL particle number
9.9% increase in LDL-C
4.8% decrease in systolic blood pressure and 4.3% decrease in diastolic blood pressure
39.3% reduction in hsCRP (a marker of inflammation)
There were no significant changes in total LDL particle number or ApoB.
Taken collectively, this trial demonstrated that one year of compliance with a ketogenic diet led to a variety of shifts in subjects’ lipid profiles. With the exception of an increase in LDL-C, all other shifts showed either a neutral or beneficial effect on overall cardiovascular risk. The simultaneous decreases in inflammation (i.e., a 39% reduction in hsCRP) and blood pressure further support a decrease in cardiovascular risk.
Note: The authors noted that a small number of participants (<1%) experienced adverse effects related to cardiovascular risk as assessed by lipid profile changes, which suggests that subjects should be monitored while following a ketogenic diet.
Cardiovascular Disease Risk Factor Responses to a Type 2 Diabetes Care Model Including Nutritional Ketosis Induced by Sustained Carbohydrate Restriction at 1 Year