N/A
Completed N=68
Effects of Lentinula Edodes Bars on Dyslipidemia and Oxidative Stress in Cholesterol Individuals: Randomized Study
Dyslipidemias
Source: ClinicalTrials.gov NCT04186780 ↗
Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Total Cholesterol Levels — 222.8; 228.2; 226.7; 229.6 mg/dL — p=0.59
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Cholesterol Levels |
222.8; 228.2; 226.7; 229.6 | 0.59 |
| PRIMARY Triglycerides Levels |
144.5; 178.9; 207.7; 160.7 | 0.0352 sig |
| SECONDARY Oxidative Stress: Catalase |
3.5; 3.1; 3.7; 3.7 | 0.8284 |
| SECONDARY Oxidative Stress: Reduced Glutathione (GSH) |
0.4; 0.4; 0.6; 0.5 | 0.0058 sig |
| SECONDARY Oxidative Stress: Thiobarbituric Acid Reactive Substances (TBARS) |
13.9; 14.6; 14.7; 13.9 | 0.0384 sig |
Eligibility Criteria
Inclusion Criteria
- Individuals aged from 20 to 65 years old, of both gender, who had at least one of the following biochemical markers at the borderline level (total cholesterol 180 to 239 mg/dL; LDL 130 to 159 mg/dL; triglycerides of 150 to 200 mg/dL), were recruited, diagnosed by biochemical exams with dates recent to the day of recruitment. The be tolerant to bars ingredients and to Shiitake. Availability to attend the date and time of blood collection.
Exclusion Criteria
- However, some of them had diseases such as cancer, heart disease, neurodegenerative disease, diabetes, among others. These diseases could be considered as confounders of the study and some recruited people had to be excluded. Pregnant, lactating or hormone replacement women could not participate either.
Individuals were instructed to no change their eating habits and patterns, physical activity level or oral contraceptive use during the study, thus identifying only the effects of Shiitake added to the diet for each individual on the exposed group
Data sourced from ClinicalTrials.gov (NCT04186780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.