Evaluation of the Effect of a Shiitake Extract on Lipid Profile in Subjects With Moderate Hyperlipidemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypercholesterolemia, Hyperlipidemias, Dietary Supplements, Cardiovascular Risk Factor

Intervention / Treatment
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* Dietary Supplement: Experimental product
* Dietary Supplement: Placebo product


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental product<br>Dietary supplement (Shiitake extract) in a commercial soup at lunch for 8 weeks. | Dietary Supplement: Experimental product<br>* 10 g/day<br>|
| Placebo Comparator: Placebo product<br>Isocaloric placebo (maltodextrin) in a commercial soup at lunch for 8 weeks. | Dietary Supplement: Placebo product<br>* 10 g/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Total Cholesterol | Total Cholesterol | Week 0 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Lipid Metabolism Parameters | High Density Lipoprotein | Week 0 and 8 | 
| Change from Baseline Lipid Metabolism Parameters | Low Density Lipoprotein | Week 0 and 8 | 
| Change from Baseline Lipid Metabolism Parameters | Triglycerides | Week 0 and 8 | 
| Change from Baseline Lipid Metabolism Parameters | Apolipoprotein B, Apolipoprotein A1, Pancreatic lipase | Week 0 and 8 | 
| Change from Baseline Satiety Hunger Assessment | Visual Analogue Scale (VAS). 100mm horizontal line anchored at each end with the extremes of the subjective feeling to be quantified. Subjects are instructed to rate the sensation being experienced according to how they define the line. e.g., not at all hungry (0mm) and as hungry as I have ever felt (100mm). Multiple measures are taken at repeated time intervals described below. | Week 0 and 8 | 
| Total amount of food consumed in 24h | 24h Food Record Method | Week 0 and 8 | 
| Change from Baseline Vitamin D | Vitamin D | Week 0 and 8 | 
| Change from Baseline Anthropometric Parameters | Weight and Height to calcule BMI in kg/m2 | Week 0 and 8 | 
| Change from Baseline Anthropometric Parameters | Waist Circumference | Week 0 and 8 | 
| Sensory Perception | Questionnaire of analysis of sensory perception of the food study product. Five questions that are valued on a scale of 0% to 100% asking about the taste and smell of the study product: desire with which the product is taken, taste, smell, consistency and what wait for effectiveness. | Week 4 | 
| Change from Baseline Glucose Parameters | Glucose | Week 0 and 8 | 
| Change from Baseline Inflammation Parameters | PCR, fibrinogen, IL-6, IL-10, TNFalpha | Week 0 and 8 | 
| Adverse Effects | Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders) | Week 0, 4 and 8 | 
| Change from Baseline Markers of oxidation | LDLox | Week 0 and 8 |