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
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia Hyperlipidemias Dietary Supplements Cardiovascular Risk Factor||Dietary Supplement: Experimental product Dietary Supplement: Placebo product||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: Experimental product
Dietary supplement (Shiitake extract) in a commercial soup at lunch for 8 weeks.
Dietary Supplement: Experimental product
Placebo Comparator: Placebo product
Isocaloric placebo (maltodextrin) in a commercial soup at lunch for 8 weeks.
Dietary Supplement: Placebo product
- Change from Baseline Total Cholesterol [ Time Frame: Week 0 and 8 ]Total Cholesterol
- 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
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
|Institute for Health Research IdiPAZ|
|Madrid, Spain, 28046|
|Principal Investigator:||Carmen Gómez Candela, PhD, MS||Institute for Health Research IdiPAZ|