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

Phase 4

Completed

• Conditions: Cardiovascular Risk Factor; Hyperlipidemias; Hypercholesterolemia; Dietary Supplements
• Interventions: Dietary Supplement: Experimental product; Dietary Supplement: Placebo product

• Registration Number: NCT03550287
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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.

Study Timeline

• Study Start: 2017-05-08
• Primary Completion: 2017-06-30
• Study Completion: 2017-12-31
• Status Verified: 2018-04
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-06-08
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental product	Experimental product	Dietary supplement (Shiitake extract) in a commercial soup at lunch for 8 weeks.
Placebo product	Placebo product	Isocaloric placebo (maltodextrin) in a commercial soup at lunch for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Total Cholesterol	Week 0 and 8	Total Cholesterol

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Vitamin D	Week 0 and 8	Vitamin D
Adverse Effects	Week 0, 4 and 8	Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Change from Baseline Markers of oxidation	Week 0 and 8	LDLox
Change from Baseline Satiety Hunger Assessment	Week 0 and 8	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.
Sensory Perception	Week 4	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.
Change from Baseline Lipid Metabolism Parameters	Week 0 and 8	Apolipoprotein B, Apolipoprotein A1, Pancreatic lipase
Change from Baseline Inflammation Parameters	Week 0 and 8	PCR, fibrinogen, IL-6, IL-10, TNFalpha
Total amount of food consumed in 24h	Week 0 and 8	24h Food Record Method
Change from Baseline Anthropometric Parameters	Week 0 and 8	Waist Circumference
Change from Baseline Glucose Parameters	Week 0 and 8	Glucose

Trial Locations

Locations (1)

Institute for Health Research IdiPAZ; 🇪🇸 Madrid, Spain