Phytosterols provide dual lipid benefits for people with or at risk for diabetes, study shows
- Randomized, double-blind, placebo-controlled study
- 138 adults with or at risk of developing type 2 diabetes
- 6% reduction in LDL cholesterol vs. placebo
- 3% reduction in triglycerides vs. placebo
- Effective dosage is 1.1 g, twice daily, for 6 weeks of plant sterols
This randomized, double-blind, placebo-controlled, parallel study was designed to investigate the effect of plant sterols (PS) on lowering both elevated low-density lipoprotein (LDL) cholesterol and triglycerides (TG) in adults at increased risk for or with established type 2 diabetes.
The researchers enrolled 161 adults with established and controlled type 2 diabetes on a stable dose of glucose-lowering or statin medication for at least 3 months and adults at high risk of developing type 2 diabetes. Increased risk was defined by the Australian Type 2 Diabetes Risk Assessment Tool (AUSDRISK), a simple validated tool based on demographic, lifestyle and anthropometric information.
Participants were randomly assigned to consume low-fat spreads without or with added PS (2.2 g/day) for 6 weeks after a 2-week run-in period. The primary outcome measures were the changes in blood levels of LDL cholesterol and triglycerides.
A total of 86% (138/161) of the participants completed the study and were included in the per-protocol analysis (57% men, 43% women; 44 with and 94 at risk of type 2 diabetes). No significant between-group differences were reported at baseline. Mean age was 58+10 years (placebo) and 59+10 years (PS group). Mean body mass index (BMI) was 34+6 kg/m2 (placebo) and 33+5 kg/m2 (PS group). Baseline LDL cholesterol and triglycerides were 3.8±1.0 and 2.5±0.8 mmol/l, respectively.
Results indicate that, compared to placebo, PS intake significantly lowered fasting LDL cholesterol (-4.6%, 95% CI -1.2; -8.0; P=.009), total cholesterol (-4.2%, 95% CI -1.2; -7.1; P=.006) and triglycerides (-8.3%, 95% CI -1.1, -15.0; P=.024). No significant changes in high-density lipoprotein (HDL) cholesterol, glucose or insulin were reported, and postprandial lipid, glucose and insulin responses did not differ.
Treatment was well tolerated with only one minor adverse event (loose stools) definitely related to PS use.
These findings indicate supplementing with PS (2.2 g/day for 6 weeks) is well tolerated and helps lower elevated blood triglycerides and LDL cholesterol levels in adults at risk of developing or with established type 2 diabetes.