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

NCT03550287 | Completed Phase 4

• 1 other identifier: 4813
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia; Hyperlipidemias; Dietary Supplements; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Total Cholesterol

  Total Cholesterol

  Week 0 and 8

Secondary Outcomes (14)

• Change from Baseline Lipid Metabolism Parameters

  Week 0 and 8

• Change from Baseline Lipid Metabolism Parameters

  Week 0 and 8

• Change from Baseline Lipid Metabolism Parameters

  Week 0 and 8

• Change from Baseline Lipid Metabolism Parameters

  Week 0 and 8

• Change from Baseline Satiety Hunger Assessment

  Week 0 and 8

Study Arms (2)

Experimental product

EXPERIMENTAL

Dietary supplement (Shiitake extract) in a commercial soup at lunch for 8 weeks.

Dietary Supplement: Experimental product

Placebo product

PLACEBO COMPARATOR

Isocaloric placebo (maltodextrin) in a commercial soup at lunch for 8 weeks.

Dietary Supplement: Placebo product

Interventions

Experimental product DIETARY_SUPPLEMENT

10 g/day

Experimental product

Placebo product DIETARY_SUPPLEMENT

10 g/day

Placebo product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Carmen Gómez Candela, PhD, MS

  Institute for Health Research IdiPAZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 8, 2018
• Study Start: May 8, 2017
• Primary Completion: June 30, 2017
• Study Completion: December 31, 2017
• Last Updated: January 13, 2022

Record last verified: 2018-04

Locations

ES (1)