Impact of a 2-year trial of nutritional ketosis on indices of cardiovascular disease risk in patients with type 2 diabetes.
Study Goal
The researchers aimed to assess the impact of a very low carbohydrate diet inducing nutritional ketosis on markers of atherosclerotic cardiovascular disease risk, particularly lipoprotein subfractions and carotid-artery intima-media thickness, in patients with type 2 diabetes.
Results Summary
The study found that the diet reduced small LDL particles (linked to CVD risk) and increased larger LDL particles, without increasing total LDL particles or ApoB, and showed no adverse progression in carotid-artery intima-media thickness. The results suggest the diet did not negatively affect CVD risk despite higher LDL-C levels.
Population
Patients with type 2 diabetes (CCI group: n=194; usual care group: n=68).
Effective Dosage
Not specified
Duration
2 years
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
consumption of a very low carbohydrate diet capable of inducing nutritional ketosis over 2 years (continuous care intervention, CCI) | decrease | body weight | patients with type 2 diabetes (T2D) | - | resulted in improved | #1 |
consumption of a very low carbohydrate diet capable of inducing nutritional ketosis over 2 years (continuous care intervention, CCI) | improve | glycemic control | patients with type 2 diabetes (T2D) | - | resulted in improved | #2 |
consumption of a very low carbohydrate diet capable of inducing nutritional ketosis over 2 years (continuous care intervention, CCI) | decrease | multiple risk factors for cardiovascular disease (CVD) | patients with type 2 diabetes (T2D) | - | resulted in improved | #3 |
consumption of a very low carbohydrate diet capable of inducing nutritional ketosis over 2 years (continuous care intervention, CCI) | increase | low density lipoprotein cholesterol (LDL-C) | patients with type 2 diabetes (T2D) | - | resulted in | #4 |
consumption of a very low carbohydrate diet capable of inducing nutritional ketosis over 2 years (continuous care intervention, CCI) | decrease | small LDL IIIb | patients with T2D who completed 2 years of this study | 23% | resulted in a 23% decrease of | #5 |
consumption of a very low carbohydrate diet capable of inducing nutritional ketosis over 2 years (continuous care intervention, CCI) | increase | large LDL I | patients with T2D who completed 2 years of this study | 29% | resulted in a 29% increase of | #6 |
consumption of a very low carbohydrate diet capable of inducing nutritional ketosis over 2 years (continuous care intervention, CCI) | no change | total LDL particle concentration | patients with T2D who completed 2 years of this study | no change | resulted in | #7 |
consumption of a very low carbohydrate diet capable of inducing nutritional ketosis over 2 years (continuous care intervention, CCI) | no change | ApoB | patients with T2D who completed 2 years of this study | no change | resulted in | #8 |
consumption of a very low carbohydrate diet capable of inducing nutritional ketosis over 2 years (continuous care intervention, CCI) | decrease | small LDL subclass phenotype B | CCI participants | 48.1% | was reflected by reversal of | #9 |
consumption of a very low carbohydrate diet capable of inducing nutritional ketosis over 2 years (continuous care intervention, CCI) | increase | larger cholesterol-enriched LDL particles | CCI group | - | was attributed to | #10 |
consumption of a very low carbohydrate diet capable of inducing nutritional ketosis over 2 years (continuous care intervention, CCI) | no change | carotid-artery intima-media thickness (CIMT) | CCI group | no change | showed | #11 |
usual care (UC) | no change | carotid-artery intima-media thickness (CIMT) | UC group | no change | showed | #12 |
consumption of a very low carbohydrate diet with nutritional ketosis for 2 years | decrease | small LDL particles | patients with type 2 diabetes | - | lowered levels of | #13 |
consumption of a very low carbohydrate diet with nutritional ketosis for 2 years | increase | larger LDL particles | patients with type 2 diabetes | - | resulted in a corresponding increase in concentrations of | #14 |
consumption of a very low carbohydrate diet with nutritional ketosis for 2 years | increase | higher levels of plasma LDL-C | patients with type 2 diabetes | - | resulted in | #15 |
this dietary intervention | no change | risk of CVD | - | - | did not adversely affect | #16 |
BACKGROUND: We have previously reported that in patients with type 2 diabetes (T2D) consumption of a very low carbohydrate diet capable of inducing nutritional ketosis over 2 years (continuous care intervention, CCI) resulted in improved body weight, glycemic control, and multiple risk factors for cardiovascular disease (CVD) with the exception of an increase in low density lipoprotein cholesterol (LDL-C). In the present study, we report the impact of this intervention on markers of risk for atherosclerotic cardiovascular disease (CVD), with a focus on lipoprotein subfraction particle concentrations as well as carotid-artery intima-media thickness (CIMT). METHODS: Analyses were performed in patients with T2D who completed 2 years of this study (CCI; n = 194; usual care (UC): n = 68). Lipoprotein subfraction particle concentrations were measured by ion mobility at baseline, 1, and 2 years and CIMT was measured at baseline and 2 years. Principal component analysis (PCA) was used to assess changes in independent clusters of lipoprotein particles. RESULTS: At 2 years, CCI resulted in a 23% decrease of small LDL IIIb and a 29% increase of large LDL I with no change in total LDL particle concentration or ApoB. The change in proportion of smaller and larger LDL was reflected by reversal of the small LDL subclass phenotype B in a high proportion of CCI participants (48.1%) and a shift in the principal component (PC) representing the atherogenic lipoprotein phenotype characteristic of T2D from a major to a secondary component of the total variance. The increase in LDL-C in the CCI group was mainly attributed to larger cholesterol-enriched LDL particles. CIMT showed no change in either the CCI or UC group. CONCLUSION: Consumption of a very low carbohydrate diet with nutritional ketosis for 2 years in patients with type 2 diabetes lowered levels of small LDL particles that are commonly increased in diabetic dyslipidemia and are a marker for heightened CVD risk. A corresponding increase in concentrations of larger LDL particles was responsible for higher levels of plasma LDL-C. The lack of increase in total LDL particles, ApoB, and in progression of CIMT, provide supporting evidence that this dietary intervention did not adversely affect risk of CVD.