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

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ClinicalTrials.gov Identifier: NCT03550287
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

Tracking Information
First Submitted Date  ICMJE May 8, 2018
First Posted Date  ICMJE June 8, 2018
Last Update Posted Date June 8, 2018
Actual Study Start Date  ICMJE May 8, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
Change from Baseline Total Cholesterol [ Time Frame: Week 0 and 8 ]
Total Cholesterol
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • Change from Baseline Lipid Metabolism Parameters [ Time Frame: Week 0 and 8 ]
    High Density Lipoprotein
  • Change from Baseline Lipid Metabolism Parameters [ Time Frame: Week 0 and 8 ]
    Low Density Lipoprotein
  • Change from Baseline Lipid Metabolism Parameters [ Time Frame: Week 0 and 8 ]
    Triglycerides
  • Change from Baseline Lipid Metabolism Parameters [ Time Frame: Week 0 and 8 ]
    Apolipoprotein B, Apolipoprotein A1, Pancreatic lipase
  • Change from Baseline Satiety Hunger Assessment [ Time Frame: 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.
  • Total amount of food consumed in 24h [ Time Frame: Week 0 and 8 ]
    24h Food Record Method
  • Change from Baseline Vitamin D [ Time Frame: Week 0 and 8 ]
    Vitamin D
  • Change from Baseline Anthropometric Parameters [ Time Frame: Week 0 and 8 ]
    Weight and Height to calcule BMI in kg/m2
  • Change from Baseline Anthropometric Parameters [ Time Frame: Week 0 and 8 ]
    Waist Circumference
  • Sensory Perception [ Time Frame: 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 Glucose Parameters [ Time Frame: Week 0 and 8 ]
    Glucose
  • Change from Baseline Inflammation Parameters [ Time Frame: Week 0 and 8 ]
    PCR, fibrinogen, IL-6, IL-10, TNFalpha
  • Adverse Effects [ Time Frame: Week 0, 4 and 8 ]
    Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
  • Change from Baseline Markers of oxidation [ Time Frame: Week 0 and 8 ]
    LDLox
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effect of a Shiitake Extract on Lipid Profile in Subjects With Moderate Hyperlipidemia
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypercholesterolemia
  • Hyperlipidemias
  • Dietary Supplements
  • Cardiovascular Risk Factor
Intervention  ICMJE
  • Dietary Supplement: Experimental product
    10 g/day
  • Dietary Supplement: Placebo product
    10 g/day
Study Arms  ICMJE
  • Experimental: Experimental product
    Dietary supplement (Shiitake extract) in a commercial soup at lunch for 8 weeks.
    Intervention: Dietary Supplement: Experimental product
  • Placebo Comparator: Placebo product
    Isocaloric placebo (maltodextrin) in a commercial soup at lunch for 8 weeks.
    Intervention: Dietary Supplement: Placebo product
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2018)
58
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03550287
Other Study ID Numbers  ICMJE 4813
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto de Investigación Hospital Universitario La Paz
Study Sponsor  ICMJE Instituto de Investigación Hospital Universitario La Paz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carmen Gómez Candela, PhD, MS Institute for Health Research IdiPAZ
PRS Account Instituto de Investigación Hospital Universitario La Paz
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP