Adults 20 to 65, any sex, with Dyslipidemias. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total Cholesterol LevelsPrimary· Assessed at 0, 33 and 66 days. Days 0 and 66 reported.
Total cholesterol It was analyzed by commercial kits, according to the manufacturer's specifications. The volunteers' Total Cholesterol and Triglyceride levels were analyzed at Time 0 (when starting the study), at Time 33 (after 33 days) and at Time 66 (after 66 days).
Total Cholesterol T0
Group
Value
95% CI
Placebo Group
222.8
± 33.1
Intervention Group
228.2
± 45.4
Total Cholesterol T66
Group
Value
95% CI
Placebo Group
226.7
± 41.3
Intervention Group
229.6
± 38.2
Oxidative Stress: CatalaseSecondary· Assessed at 0, 33 and 66 days. Days 0 and 66 reported.
The activity of the catalase enzyme was based on the decomposition of H2O2, monitored at 240 nm. A constant of variation or coefficient of variation (κ) per minute helped in the expression of catalase enzyme (κ/min). The Catalase enzyme has the responsibility to break down hydrogen peroxide. Higher scores mean a better outcome.
Were analyzed at Time 0 (when starting the study), at Time 33 (after 33 days) and at Time 66 (after 66 days).
Catalase T0
Group
Value
95% CI
Placebo Group
3.5
± 1.1
Intervention Group
3.1
± 0.8
Catalase T66
Group
Value
95% CI
Placebo Group
3.7
± 1.6
Intervention Group
3.7
± 2.0
Oxidative Stress: Reduced Glutathione (GSH)Secondary· Assessed at 0, 33 and 66 days. Days 0 and 66 reported.
Reduced Glutathione was analyzed in the volunteers' samples at Time 0 (at the beginning of the study), at Time 33 (after 33 days) and at Time 66 (after 66 days).
GSH T0
Group
Value
95% CI
Placebo Group
0.4
± 0.1
Intervention Group
0.4
± 0.2
GSH T66
Group
Value
95% CI
Placebo Group
0.6
± 0.2
Intervention Group
0.5
± 0.2
Oxidative Stress: Thiobarbituric Acid Reactive Substances (TBARS)Secondary· Assessed at 0, 33 and 66 days. Days 0 and 66 reported.
Reactive Substances to Thiobarbituric Acid were analyzed in the volunteers' samples at Time 0 (at the beginning of the study), at Time 33 (after 33 days) and at Time 66 (after 66 days).
TBARS T0
Group
Value
95% CI
Placebo Group
13.9
± 2.3
Intervention Group
14.6
± 2.1
TBARS T66
Group
Value
95% CI
Placebo Group
14.7
± 2.0
Intervention Group
13.9
± 2.9
Triglycerides LevelsPrimary· Assessed at 0, 33 and 66 days. Days 0 and 66 reported.
The triglycerides levels It was analyzed by commercial kits, according to the manufacturer's specifications. The volunteers' Total Cholesterol and Triglyceride levels were analyzed at Time 0 (when starting the study), at Time 33 (after 33 days) and at Time 66 (after 66 days).
Triglycerides T0
Group
Value
95% CI
Placebo Group
144.5
± 70.2
Intervention Group
178.9
± 170.1
Triglycerides T66
Group
Value
95% CI
Placebo Group
207.7
± 202.7
Intervention Group
160.7
± 94.7
Adverse events — posted to ClinicalTrials.gov
Time frame: 15 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Sorocaba
Last refreshed: 27 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04186780.