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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
57
10 g/day
10 g/day
Institute for Health Research IdiPAZ
Madrid, Spain
Change from Baseline Total Cholesterol
Total Cholesterol
Time frame: Week 0 and 8
Change from Baseline Lipid Metabolism Parameters
High Density Lipoprotein
Time frame: Week 0 and 8
Change from Baseline Lipid Metabolism Parameters
Low Density Lipoprotein
Time frame: Week 0 and 8
Change from Baseline Lipid Metabolism Parameters
Triglycerides
Time frame: Week 0 and 8
Change from Baseline Lipid Metabolism Parameters
Apolipoprotein B, Apolipoprotein A1, Pancreatic lipase
Time frame: 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.
Time frame: Week 0 and 8
Total amount of food consumed in 24h
24h Food Record Method
Time frame: Week 0 and 8
Change from Baseline Vitamin D
Vitamin D
Time frame: Week 0 and 8
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Change from Baseline Anthropometric Parameters
Weight and Height to calcule BMI in kg/m2
Time frame: Week 0 and 8
Change from Baseline Anthropometric Parameters
Waist Circumference
Time frame: 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.
Time frame: Week 4
Change from Baseline Glucose Parameters
Glucose
Time frame: Week 0 and 8
Change from Baseline Inflammation Parameters
PCR, fibrinogen, IL-6, IL-10, TNFalpha
Time frame: Week 0 and 8
Adverse Effects
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Time frame: Week 0, 4 and 8
Change from Baseline Markers of oxidation
LDLox
Time frame: Week 0 and 8