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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Hyperlipidemias Dietary Supplements Cardiovascular Risk Factor Dietary Supplement: Experimental product Dietary Supplement: Placebo product Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Total Cholesterol [ Time Frame: Week 0 and 8 ]
    Total Cholesterol


Secondary Outcome Measures :
  1. Change from Baseline Lipid Metabolism Parameters [ Time Frame: Week 0 and 8 ]
    High Density Lipoprotein

  2. Change from Baseline Lipid Metabolism Parameters [ Time Frame: Week 0 and 8 ]
    Low Density Lipoprotein

  3. Change from Baseline Lipid Metabolism Parameters [ Time Frame: Week 0 and 8 ]
    Triglycerides

  4. Change from Baseline Lipid Metabolism Parameters [ Time Frame: Week 0 and 8 ]
    Apolipoprotein B, Apolipoprotein A1, Pancreatic lipase

  5. 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.


  6. Total amount of food consumed in 24h [ Time Frame: Week 0 and 8 ]
    24h Food Record Method

  7. Change from Baseline Vitamin D [ Time Frame: Week 0 and 8 ]
    Vitamin D

  8. Change from Baseline Anthropometric Parameters [ Time Frame: Week 0 and 8 ]
    Weight and Height to calcule BMI in kg/m2

  9. Change from Baseline Anthropometric Parameters [ Time Frame: Week 0 and 8 ]
    Waist Circumference

  10. 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.

  11. Change from Baseline Glucose Parameters [ Time Frame: Week 0 and 8 ]
    Glucose

  12. Change from Baseline Inflammation Parameters [ Time Frame: Week 0 and 8 ]
    PCR, fibrinogen, IL-6, IL-10, TNFalpha

  13. Adverse Effects [ Time Frame: Week 0, 4 and 8 ]
    Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)

  14. Change from Baseline Markers of oxidation [ Time Frame: Week 0 and 8 ]
    LDLox


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550287


Locations
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Spain
Institute for Health Research IdiPAZ
Madrid, Spain, 28046
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
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Principal Investigator: Carmen Gómez Candela, PhD, MS Institute for Health Research IdiPAZ
More Information
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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT03550287     History of Changes
Other Study ID Numbers: 4813
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Hyperlipoproteinemias
 Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases