Effects of Lentinula Edodes Bar on Lipid Profile and Antioxidant Status in Borderline High Cholesterol Individuals: a Double Blind Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Triglycerides Levels
Study Overview
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.
Detailed Description
Study design The primary outcome of the study was cholesterolemia, as assessed by total cholesterol levels, triglycerides or low-density lipoproteins (LDL) and high-density lipoproteins (HDL). The secondary outcomes included blood glucose, Body Mass Index (BMI) and oxidative stress biomarkers.
A prospective Phase II, randomized, double blind and placebo-controlled trial was conducted from September 2018 to December 2018. The study accomplished at University of Sorocaba (UNISO), São Paulo State, Brazil. The study was approved (Annex D) by Human Research Ethics Committee from University of Sorocaba (protocol number 2.824.297), in accordance with Resolution 466/2012 of the National Health Council (BRASIL, 2012) and Research Ethics Review Committee (ERC) (WHO, 2016).
Recruitment of individuals For the recruitment of individuals, the disclosure was initiated five months before the start of Phase II trial. The research was published on the website of the University of Sorocaba (UNISO), on social media and folders distributed throughout campus containing a brief explanation about the research, inclusion and exclusion criteria, and contact of the researcher. According to the Resolution 1.170, from Anvisa (National Health Surveillance Agency), Phase II studies are not allowed with less than 12 people; however, the Agency suggests using a minimum of 24 volunteers.
Eligibility Criteria A total of 165 individuals completed the Google online survey.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo group
Patients with borderline cholesterol consumed two placebo cereal bars for 66 days.
Intervention: Shiitake cereal bar (Other)
Intervention group
Intervention group: patients with borderline cholesterol consumed two cereal bars with Shiitake per day for 66 days.
Intervention: Shiitake cereal bar (Other)
Outcomes
Primary Outcomes
Triglycerides Levels
Time Frame: 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).
Total Cholesterol Levels
Time Frame: 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).
Secondary Outcomes
- 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.)
- Oxidative Stress: Catalase(Assessed at 0, 33 and 66 days. Days 0 and 66 reported.)
Investigators
Luciane Cruz Lopes
Responsible researcher
University of Sorocaba