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

Hypercholesterolemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550287
• Other study ID #: 4813
• Status: Completed
• Phase: Phase 4
• Start date: May 8, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2018
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 31, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Dietary Supplements
• Hypercholesterolemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• Experimental product
10 g/day
• Placebo product
10 g/day

Locations

Country	Name	City	State
Spain	Institute for Health Research IdiPAZ	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Total Cholesterol	Total Cholesterol	Week 0 and 8
Secondary	Change from Baseline Lipid Metabolism Parameters	High Density Lipoprotein	Week 0 and 8
Secondary	Change from Baseline Lipid Metabolism Parameters	Low Density Lipoprotein	Week 0 and 8
Secondary	Change from Baseline Lipid Metabolism Parameters	Triglycerides	Week 0 and 8
Secondary	Change from Baseline Lipid Metabolism Parameters	Apolipoprotein B, Apolipoprotein A1, Pancreatic lipase	Week 0 and 8
Secondary	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.	Week 0 and 8
Secondary	Total amount of food consumed in 24h	24h Food Record Method	Week 0 and 8
Secondary	Change from Baseline Vitamin D	Vitamin D	Week 0 and 8
Secondary	Change from Baseline Anthropometric Parameters	Weight and Height to calcule BMI in kg/m2	Week 0 and 8
Secondary	Change from Baseline Anthropometric Parameters	Waist Circumference	Week 0 and 8
Secondary	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.	Week 4
Secondary	Change from Baseline Glucose Parameters	Glucose	Week 0 and 8
Secondary	Change from Baseline Inflammation Parameters	PCR, fibrinogen, IL-6, IL-10, TNFalpha	Week 0 and 8
Secondary	Adverse Effects	Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)	Week 0, 4 and 8
Secondary	Change from Baseline Markers of oxidation	LDLox	Week 0 and 8