Trial Outcomes & Findings for Effects of Lentinula Edodes Bars on Dyslipidemia and Oxidative Stress in Cholesterol Individuals: Randomized Study (NCT NCT04186780)
NCT ID: NCT04186780
Last Updated: 2020-10-27
Results Overview
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).
COMPLETED
NA
68 participants
Assessed at 0, 33 and 66 days. Days 0 and 66 reported.
2020-10-27
Participant Flow
The patients were received in September, October and November in the nursing room at the University for the meetings.
Individuals aged from 20 to 65 years old, who had at least one of the following biochemical markers at the borderline level, were recruited. Must be tolerant to bars ingredients and to Shiitake and they must be availability to attend the date and time of blood collection. Some of the individuals had diseases such as cancer, heart disease, neurodegenerative disease, diabetes, among others. These diseases could be confounders of the study and some recruited people had to be excluded.
Participant milestones
| Measure |
Intervention Group
Intervention group: patients with borderline cholesterol consumed two cereal bars with Shiitake per day for 66 days.
Shiitake cereal bar: patients with borderline cholesterol exposed to bars with Shiitake
|
Placebo Group
Patients with borderline cholesterol consumed two placebo cereal bars for 66 days.
Placebo cereal bar: patients with borderline cholesterol exposed to cereal bars without Shiitake.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
32
|
|
Overall Study
COMPLETED
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
14
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Lentinula Edodes Bars on Dyslipidemia and Oxidative Stress in Cholesterol Individuals: Randomized Study
Baseline characteristics by cohort
| Measure |
Intervention Group
n=36 Participants
Intervention group: patients with borderline cholesterol consumed two cereal bars with Shiitake per day for 66 days.
Shiitake cereal bar: patients with borderline cholesterol exposed to bars with Shiitake
|
Placebo Group
n=32 Participants
Patients with borderline cholesterol consumed two placebo cereal bars for 66 days.
Cereal bar: patients with borderline cholesterol exposed to placebo cereal bars.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42 Years
STANDARD_DEVIATION 12 • n=5 Participants
|
38 Years
STANDARD_DEVIATION 11 • n=7 Participants
|
40 Years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Measure Smoker tobacco
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Number of Participants Reporting Alcohol Consumption
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Number of Participants Reporting Regular Physical Activity
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
BMI - Body mass index
|
26.4 kg/m²
STANDARD_DEVIATION 4.4 • n=5 Participants
|
27.5 kg/m²
STANDARD_DEVIATION 4.4 • n=7 Participants
|
26.9 kg/m²
STANDARD_DEVIATION 4.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at 0, 33 and 66 days. Days 0 and 66 reported.Population: Individuals aged from 20 to 65 years old, of both gender, who had at least one of the following biochemical markers at the borderline high level (total cholesterol 180 to 239 mg/dL; LDL 130 to 159 mg/dL; TG of 150 to 200 mg/dL)
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).
Outcome measures
| Measure |
Placebo Group
n=32 Participants
Participants received two placebo food bars/day to consume for 66 days. Placebo: Placebo food bars with 25 g each.
|
Intervention Group
n=36 Participants
Participants received two shiitake food bars/day to consume for 66 days. Intervention group: Shiitake bars with 25 g each.
|
|---|---|---|
|
Total Cholesterol Levels
Total Cholesterol T66
|
226.7 mg/dL
Standard Deviation 41.3
|
229.6 mg/dL
Standard Deviation 38.2
|
|
Total Cholesterol Levels
Total Cholesterol T0
|
222.8 mg/dL
Standard Deviation 33.1
|
228.2 mg/dL
Standard Deviation 45.4
|
PRIMARY outcome
Timeframe: Assessed at 0, 33 and 66 days. Days 0 and 66 reported.Population: Individuals aged from 20 to 65 years old, of both gender, who had at least one of the following biochemical markers at the borderline high level (total cholesterol 180 to 239 mg/dL; LDL 130 to 159 mg/dL; TG of 150 to 200 mg/dL)
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).
Outcome measures
| Measure |
Placebo Group
n=32 Participants
Participants received two placebo food bars/day to consume for 66 days. Placebo: Placebo food bars with 25 g each.
|
Intervention Group
n=36 Participants
Participants received two shiitake food bars/day to consume for 66 days. Intervention group: Shiitake bars with 25 g each.
|
|---|---|---|
|
Triglycerides Levels
Triglycerides T0
|
144.5 mg/dL
Standard Deviation 70.2
|
178.9 mg/dL
Standard Deviation 170.1
|
|
Triglycerides Levels
Triglycerides T66
|
207.7 mg/dL
Standard Deviation 202.7
|
160.7 mg/dL
Standard Deviation 94.7
|
SECONDARY outcome
Timeframe: Assessed at 0, 33 and 66 days. Days 0 and 66 reported.Population: Individuals aged from 20 to 65 years old, of both gender, who had at least one of the following biochemical markers at the borderline high level (total cholesterol 180 to 239 mg/dL; LDL 130 to 159 mg/dL; TG of 150 to 200 mg/dL)
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).
Outcome measures
| Measure |
Placebo Group
n=32 Participants
Participants received two placebo food bars/day to consume for 66 days. Placebo: Placebo food bars with 25 g each.
|
Intervention Group
n=36 Participants
Participants received two shiitake food bars/day to consume for 66 days. Intervention group: Shiitake bars with 25 g each.
|
|---|---|---|
|
Oxidative Stress: Catalase
Catalase T0
|
3.5 k/min
Standard Deviation 1.1
|
3.1 k/min
Standard Deviation 0.8
|
|
Oxidative Stress: Catalase
Catalase T66
|
3.7 k/min
Standard Deviation 1.6
|
3.7 k/min
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Assessed at 0, 33 and 66 days. Days 0 and 66 reported.Population: Individuals aged from 20 to 65 years old, of both gender, who had at least one of the following biochemical markers at the borderline high level (total cholesterol 180 to 239 mg/dL; LDL 130 to 159 mg/dL; TG of 150 to 200 mg/dL)
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).
Outcome measures
| Measure |
Placebo Group
n=32 Participants
Participants received two placebo food bars/day to consume for 66 days. Placebo: Placebo food bars with 25 g each.
|
Intervention Group
n=36 Participants
Participants received two shiitake food bars/day to consume for 66 days. Intervention group: Shiitake bars with 25 g each.
|
|---|---|---|
|
Oxidative Stress: Reduced Glutathione (GSH)
GSH T0
|
0.4 mM
Standard Deviation 0.1
|
0.4 mM
Standard Deviation 0.2
|
|
Oxidative Stress: Reduced Glutathione (GSH)
GSH T66
|
0.6 mM
Standard Deviation 0.2
|
0.5 mM
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Assessed at 0, 33 and 66 days. Days 0 and 66 reported.Population: Individuals aged from 20 to 65 years old, of both gender, who had at least one of the following biochemical markers at the borderline high level (total cholesterol 180 to 239 mg/dL; LDL 130 to 159 mg/dL; TG of 150 to 200 mg/dL)
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).
Outcome measures
| Measure |
Placebo Group
n=32 Participants
Participants received two placebo food bars/day to consume for 66 days. Placebo: Placebo food bars with 25 g each.
|
Intervention Group
n=36 Participants
Participants received two shiitake food bars/day to consume for 66 days. Intervention group: Shiitake bars with 25 g each.
|
|---|---|---|
|
Oxidative Stress: Thiobarbituric Acid Reactive Substances (TBARS)
TBARS T0
|
13.9 µM
Standard Deviation 2.3
|
14.6 µM
Standard Deviation 2.1
|
|
Oxidative Stress: Thiobarbituric Acid Reactive Substances (TBARS)
TBARS T66
|
14.7 µM
Standard Deviation 2.0
|
13.9 µM
Standard Deviation 2.9
|
Adverse Events
Intervention Group
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=36 participants at risk
Intervention group: patients with borderline cholesterol consumed two cereal bars with Shiitake per day for 66 days.
The patients can manifest allergy to ingredients the bars
|
Placebo Group
n=32 participants at risk
Patients with borderline cholesterol consumed two placebo cereal bars for 66 days.
The patients can manifest allergy to ingredients the bars.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Allergic Reaction
|
19.4%
7/36 • Number of events 36 • 15 days
7 patients communicated the manifestation of the allergic reaction.
|
0.00%
0/32 • Number of events 32 • 15 days
7 patients communicated the manifestation of the allergic reaction.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place