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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia; Hyperlipidemias; Cardiovascular Risk Factor; Dietary Supplements
• Intervention / Treatment: Dietary supplement: Experimental product; Dietary supplement: Placebo product

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Institute for Health Research IdiPAZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Investigators: Principal Investigator: Carmen Gómez Candela, PhD, MS, Institute for Health Research IdiPAZ

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: 4813

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No