Safety of Overconsumption (Five Dose) of a Food Containing of Mushroom Mycelium

Not Applicable

• Conditions: /A(healthy adults)

• Registration Number: JPRN-UMIN000023945
• Lead Sponsor: RCT Japan Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

[1]Individuals using medical products [2]Individuals who is patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia [3]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis) [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease [5]Individuals who is a patient or have a history of or endocrine disease [6]Individuals whose BMI is over 30 [7]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [8]Individuals with serious anemia [9]Individuals who are sensitive to a test product or other foods, and medical products [10]Individuals who are or are possibly, or are lactating [11]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [12]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period [13]Individuals who participated in other clinical studies in the past 3 months [14]Individuals judged inappropriate for the study by the principal

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[1]Existence and its contents of side effects(Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods)

Secondary Outcome Measures

Name	Time	Method
*Secondary outcomes [1]Adverse events (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [2]Blood pressure, pulsation (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [3]Weight, body fat percentage, BMI (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [4]Body temperature (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [5]Hematologic test (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [6]Blood biochemical test (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [7]Urine analysis (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) [8]Doctor's questions (Week 0, Week 2, Week 4, 4 weeks after the end of ingestion of test foods) *Other index [1]Subject's diary (each day during the test period)