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Effects of Lentinula Edodes Bars on Dyslipidemia and Oxidative Stress in Cholesterol Individuals: Randomized Study

NCT04186780 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2020-10-27

Study results available
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Summary

The daily change in population routine has stimulated the development of health beneficial value added products. Lentinula edodes (Shiitake) is a mushroom with high protein concentration, low lipid content, rich in fiber, minerals, vitamins, antioxidant compounds, β-glucans and chitosan. This is clinical study phase II, randomized, double-blind for analyze in the effect of eating Shiitake bars on cholesterolemia and oxidative stress levels in individuals with borderline cholesterol. Individuals with at least one of the following biochemical markers (total cholesterol, LDL or triglycerides) at the borderline level were recruited through online questionnaire. Individuals (n = 68) were randomly allocated to two groups (Group I - Shiitake free bar (n = 32); Group II - Shiitake bar (n = 36). Each individual underwent blood collection at 0, 33 and 66 days, and received an unidentified opaque bag containing the bars.Biochemical analyzes (triglycerides, total cholesterol, LDL, HDL and glucose) and oxidative stress markers (Catalase, GSH and TBARS) were performed on samples of individuals.

Conditions

  • Dyslipidemias

Interventions

OTHER

Shiitake cereal bar

patients with borderline cholesterol exposed to bars with Shiitake

Sponsors & Collaborators

  • University of Sorocaba

    lead OTHER

Principal Investigators

  • Paula M Bertoni, MSc · University of Sorocaba

  • Miriam SN Silveira, MSc · University of Sorocaba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2018-12-01
Completion
2019-09-20

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04186780 on ClinicalTrials.gov