Clinical trial NCT03550287: Evaluation of the Effect of a Shiitake Extract on Lipid Profile in Subjects With Moderate Hyperlipidemia
Official title: A Clinical Trial to Evaluate the Effect of a Shiitake Mushroom Extract Supplement on Lipid Profile, Other Cardiovascular Risk Factors and the Microbiota in Subjects With and Moderate Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Hyperlipidemias
Dietary Supplements
Cardiovascular Risk Factor
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Total Cholesterol
timeFrame: Week 0 and 8
Secondary outcomes:
measure: Change from Baseline Lipid Metabolism Parameters
timeFrame: Week 0 and 8
measure: Change from Baseline Lipid Metabolism Parameters
timeFrame: Week 0 and 8
measure: Change from Baseline Lipid Metabolism Parameters
timeFrame: Week 0 and 8
measure: Change from Baseline Lipid Metabolism Parameters
timeFrame: Week 0 and 8
measure: Change from Baseline Satiety Hunger Assessment
timeFrame: Week 0 and 8
measure: Total amount of food consumed in 24h
timeFrame: Week 0 and 8
measure: Change from Baseline Vitamin D
timeFrame: Week 0 and 8
measure: Change from Baseline Anthropometric Parameters
timeFrame: Week 0 and 8
measure: Change from Baseline Anthropometric Parameters
timeFrame: Week 0 and 8
measure: Sensory Perception
timeFrame: Week 4
measure: Change from Baseline Glucose Parameters
timeFrame: Week 0 and 8
measure: Change from Baseline Inflammation Parameters
timeFrame: Week 0 and 8
measure: Adverse Effects
timeFrame: Week 0, 4 and 8
measure: Change from Baseline Markers of oxidation
timeFrame: Week 0 and 8
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute for Health Research IdiPAZ
Study officials:
affiliation: Institute for Health Research IdiPAZ
name: Carmen Gómez Candela, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: