UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060621 |
|---|---|
| Receipt number | R000069308 |
| Scientific Title | Effects of Mushroom Intake on the Profile of Blood Lipoprotein Subclasses |
| Date of disclosure of the study information | 2026/02/08 |
| Last modified on | 2026/02/08 20:39:11 |
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Basic information
Public title
Effects of Mushroom Intake on the Profile of Blood Lipoprotein Subclasses
Acronym
Effects of Mushroom Intake on the Profile of Blood Lipoprotein Subclasses
Scientific Title
Effects of Mushroom Intake on the Profile of Blood Lipoprotein Subclasses
Scientific Title:Acronym
Effects of Mushroom Intake on the Profile of Blood Lipoprotein Subclasses
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of consuming test food (mushrooms) on the profile of blood lipoprotein subclasses
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effects on lipid metabolism will be examined by analyzing the blood lipoprotein subclass profile before and after two weeks of consuming the test food (mushrooms).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume 50g of the test food (mushrooms) daily for two weeks.
Interventions/Control_2
Consume 50g of the test food (mushrooms) daily for two weeks.
Interventions/Control_3
Consume 50g of the test food (mushrooms) daily for two weeks.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women aged 18 years or older. Individuals classified as physical activity levels I or II.
Key exclusion criteria
Individuals with a history or current condition of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia, or other serious diseases.
Individuals who have habitually taken medication for the treatment of illness within the past month (excluding occasional use for headaches, menstrual pain, colds, etc.).
Individuals with a history or current condition of severe impairment of the liver, kidneys, heart, lungs, blood, etc.
Individuals with concomitant diseases or a history of severe conditions involving the digestive organs.
Individuals currently suffering from a disease and receiving drug therapy.
Individuals who have undergone surgery due to illness or injury (within 2 months prior to study start).
Individuals whose weight fluctuated by more than 2 kg (within 3 months of the trial start date).
Individuals who donated blood exceeding 200 mL within 1 month prior to the start of this trial, or 400 mL within 3 months prior.
Individuals who have previously experienced discomfort or worsening health following blood collection.
Individuals with food allergy symptoms, or those at risk of developing them.
Smokers.
Regular alcohol drinkers.
Individuals who routinely engage in strenuous exercise.
Individuals whose lifestyle habits may change during the study period (e.g., extended travel).
Individuals who are currently taking, or have taken within the past 3 months, health functional foods on a continuous basis, or who plan to take them during the study period.
Individuals who do not agree with the purpose of the study as explained during the pre-study briefing.
Pregnant, breastfeeding, or potentially pregnant individuals.
Individuals currently participating in another human clinical trial or those who have completed participation within the last 3 months.
Other individuals deemed unsuitable for this trial by the responsible physician.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Miyazawa |
Organization
Kagawa Nutrition University
Division name
Laboratory of Food Chemistry
Zip code
350-0288
Address
3-9-21 Chiyoda Sakado Saitama
TEL
049-282-3709
miyazawa.noriko@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Miyazawa |
Organization
Kagawa Nutrition University
Division name
Laboratory of Food Chemistry
Zip code
350-0288
Address
3-9-21 Chiyoda Sakado Saitama
TEL
049-282-3709
Homepage URL
miyazawa.noriko@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa Nutrition University
Address
3-9-21 Chiyoda Sakado Saitama
Tel
049-282-3709
miyazawa.noriko@eiyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
女子栄養大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 08 | Day |
Last modified on
| 2026 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069308
