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

NCT04186780 | Completed Results DMC

• 1 other identifier: 83741818.5.0000.5500
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lentinula edodes; Clinical study; Cholesterolemia; Nutraceuticals

Outcome Measures

Primary Outcomes (2)

• Total Cholesterol Levels

  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).

  Assessed at 0, 33 and 66 days. Days 0 and 66 reported.

• Triglycerides Levels

  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).

  Assessed at 0, 33 and 66 days. Days 0 and 66 reported.

Secondary Outcomes (3)

• Oxidative Stress: Catalase

  Assessed at 0, 33 and 66 days. Days 0 and 66 reported.

• Oxidative Stress: Reduced Glutathione (GSH)

  Assessed at 0, 33 and 66 days. Days 0 and 66 reported.

• Oxidative Stress: Thiobarbituric Acid Reactive Substances (TBARS)

  Assessed at 0, 33 and 66 days. Days 0 and 66 reported.

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group: patients with borderline cholesterol consumed two cereal bars with Shiitake per day for 66 days.

Other: Shiitake cereal bar

Placebo group

PLACEBO COMPARATOR

Patients with borderline cholesterol consumed two placebo cereal bars for 66 days.

Other: Shiitake cereal bar

Interventions

Shiitake cereal bar OTHER

patients with borderline cholesterol exposed to bars with Shiitake

Intervention group; Placebo group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sorocaba: lead

Study Sites (1)

University of Sorocaba

Sorocaba, São Paulo, 18023-000, Brazil

Location

Related Publications (1)

• Aebi H. Catalase in vitro. Methods Enzymol. 1984; 105: 121-126. Ellman GL. Tissue sulfhydryl groups. Arch Biochem Biophys. 1959; 82: 70-77. Friedewald, W. T.; LEVY, R. I.; Frederickson, D. S. Estimation of the concentration of low density lipoprotein in plasma without the use of the preparative ultra centrifuge. Clinical Chemistry. 1972; 18(6): 499-502 Grotto D, Gerenutti M, Souza VCO, Barbosa F Jr. Deficiency of macro and micronutrients induced by Lentinula edodes. Toxicology. 2015. 2:401-404.. Kerckhoffs DAJM, Hornstra G, Mensink RP. Cholesterol-lowering effect of β-glucan from oat bran in mildly hypercholesterolemic subjects may decrease when β-glucan is incorporated into bread and cookies. American Journal of Clinical Nutrition. 2003; 78: 221-227. Ohkawa H, OhishI N, Yagi K. Assay for lipid peroxides in animal tissues by Thiobarbituric Acid reaction. Analyt Biochem. 1979; 95: 351-358.

  BACKGROUND

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Luciane Cruz Lopes
• Organization: Universidade de Sorocaba

luciane.lopes@prof.uniso.br

+ 55 15 2101-7104

Study Officials

• Paula M Bertoni, MSc

  University of Sorocaba

  STUDY CHAIR

• Miriam SN Silveira, MSc

  University of Sorocaba

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not be informed to which group they belong, intervention or control. Who will do the randomization will not be blind, because during treatment she will know which group is eating the bars with Shiitake. The researcher responsible for the pre- and post-treatment evaluation will be blind and will not know the research intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible researcher

Model Details: Prospective, randomized, double blind and placebo-controlled

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 5, 2019
• Study Start: September 26, 2018
• Primary Completion: December 1, 2018
• Study Completion: September 20, 2019
• Last Updated: October 27, 2020
• Results First Posted: September 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After January 2021
• Access Criteria: Anyone can access the information.

Locations

BR (1)