Effect of a dietary supplement with Shiitake extracts (Lentinula edodes) on lipid profile and other cardiovascular risk factors in subjects with moderate hyperlipidemia without pharmacological treatment.

Prospective, parallel, randomized and double-blind clinical-nutritional study of 8 weeks of duration and 2 study groups (1) Food supplement with extracts of the fungus Shiitake; 2) Placebo supplement with maltodextrin) to evaluate the effect of a food supplement derived from the Shiitake mushroom (Lentinula edodes) on the lipid profile, other cardiovascular risk factors and the intestinal microbiota in subjects with hyperlipidemia moderate without pharmacological treatment.

Inclusion Criteria:

• Men and women from 18 to 65 years old.

• BMI ≥18.5 and <30 kg/m2.

• Adequate cultural level and understanding for the clinical trial.

• Signed informed consent.

• Cardiovascular risk <10% to 10 years measured by REGICOR.

• Total cholesterol ≥ 200 mg/d and at least 2 factors included in the following list:

  • ≥ 45 years or women ≥ 55 years.
  • Family history of cardiovascular disease (CVD) in first degree male relative less than 55 years of age and less than 65 years in women.
  • HDL cholesterol: men <40 or women <50.
  • Triglycerides ≥ 150mg/dL and <200 mg/dL
  • LDL cholesterol ≥ 130mg/dL and < 160mg/dL
  • Smoker

• Willingness to follow a healthy diet, hyperlipidemic control diet and a diet without stanols, sterols and yeast.

• Social or familiar environment that prevents from accomplishing the dietary treatment

Exclusion Criteria:

• Individuals diagnosed with Diabetes Mellitus type 1.
• Individuals diagnosed with Diabetes Mellitus type 2 on pharmacological treatment (unless it is possible the suspension 30 days before the trials).
• Individuals with dyslipidemia on pharmacological treatment;
• Individuals with hypertension on pharmacological treatment;
• Individuals > 60 years smokers with total cholesterol > 200mg/dL or LDL >130mg/dl.
• Individuals with hypertension on pharmacological treatment uncontrolled.
• Individuals with hyperthyroidism and hypothyroidism on pharmacological treatment uncontrolled.
• Individuals allergic to Shiitake (Lentinula edodes)
• Individuals with chronic diseases (hepatic, kidney, …)
• Individuals receiving at least the preceding 2 months a pharmacological treatment that modifies the lipid profile (for example, statins, fibrates, diuretics, corticosteroids, ADOs);
• Individuals who have participated in the last 6 months in a program or clinical trial to lose weight.
• Smokers wanting to stop to smoke during the period that clinical trial lasts.
• Individuals with mental illness.
• Consume drugs to lose weight during 30 days before starting the study
• Pregnant or breastfeeding women.