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

Primary Purpose

Hypercholesterolemia, Hyperlipidemias, Dietary Supplements

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Experimental product
Placebo product
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Institute for Health Research IdiPAZ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental product

Placebo product

Arm Description

Dietary supplement (Shiitake extract) in a commercial soup at lunch for 8 weeks.

Isocaloric placebo (maltodextrin) in a commercial soup at lunch for 8 weeks.

Outcomes

Primary Outcome Measures

Change from Baseline Total Cholesterol
Total Cholesterol

Secondary Outcome Measures

Change from Baseline Lipid Metabolism Parameters
High Density Lipoprotein
Change from Baseline Lipid Metabolism Parameters
Low Density Lipoprotein
Change from Baseline Lipid Metabolism Parameters
Triglycerides
Change from Baseline Lipid Metabolism Parameters
Apolipoprotein B, Apolipoprotein A1, Pancreatic lipase
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.
Total amount of food consumed in 24h
24h Food Record Method
Change from Baseline Vitamin D
Vitamin D
Change from Baseline Anthropometric Parameters
Weight and Height to calcule BMI in kg/m2
Change from Baseline Anthropometric Parameters
Waist Circumference
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.
Change from Baseline Glucose Parameters
Glucose
Change from Baseline Inflammation Parameters
PCR, fibrinogen, IL-6, IL-10, TNFalpha
Adverse Effects
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Change from Baseline Markers of oxidation
LDLox

Full Information

First Posted
May 8, 2018
Last Updated
January 12, 2022
Sponsor
Instituto de Investigación Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT03550287
Brief Title
Evaluation of the Effect of a Shiitake Extract on Lipid Profile in Subjects With Moderate Hyperlipidemia
Acronym
Reducol
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Hyperlipidemias, Dietary Supplements, Cardiovascular Risk Factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental product
Arm Type
Experimental
Arm Description
Dietary supplement (Shiitake extract) in a commercial soup at lunch for 8 weeks.
Arm Title
Placebo product
Arm Type
Placebo Comparator
Arm Description
Isocaloric placebo (maltodextrin) in a commercial soup at lunch for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental product
Intervention Description
10 g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo product
Intervention Description
10 g/day
Primary Outcome Measure Information:
Title
Change from Baseline Total Cholesterol
Description
Total Cholesterol
Time Frame
Week 0 and 8
Secondary Outcome Measure Information:
Title
Change from Baseline Lipid Metabolism Parameters
Description
High Density Lipoprotein
Time Frame
Week 0 and 8
Title
Change from Baseline Lipid Metabolism Parameters
Description
Low Density Lipoprotein
Time Frame
Week 0 and 8
Title
Change from Baseline Lipid Metabolism Parameters
Description
Triglycerides
Time Frame
Week 0 and 8
Title
Change from Baseline Lipid Metabolism Parameters
Description
Apolipoprotein B, Apolipoprotein A1, Pancreatic lipase
Time Frame
Week 0 and 8
Title
Change from Baseline Satiety Hunger Assessment
Description
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.
Time Frame
Week 0 and 8
Title
Total amount of food consumed in 24h
Description
24h Food Record Method
Time Frame
Week 0 and 8
Title
Change from Baseline Vitamin D
Description
Vitamin D
Time Frame
Week 0 and 8
Title
Change from Baseline Anthropometric Parameters
Description
Weight and Height to calcule BMI in kg/m2
Time Frame
Week 0 and 8
Title
Change from Baseline Anthropometric Parameters
Description
Waist Circumference
Time Frame
Week 0 and 8
Title
Sensory Perception
Description
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.
Time Frame
Week 4
Title
Change from Baseline Glucose Parameters
Description
Glucose
Time Frame
Week 0 and 8
Title
Change from Baseline Inflammation Parameters
Description
PCR, fibrinogen, IL-6, IL-10, TNFalpha
Time Frame
Week 0 and 8
Title
Adverse Effects
Description
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Time Frame
Week 0, 4 and 8
Title
Change from Baseline Markers of oxidation
Description
LDLox
Time Frame
Week 0 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gómez Candela, PhD, MS
Organizational Affiliation
Institute for Health Research IdiPAZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Health Research IdiPAZ
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

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

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