UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055496 |
|---|---|
| Receipt number | R000063208 |
| Scientific Title | Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females. |
| Date of disclosure of the study information | 2024/09/13 |
| Last modified on | 2025/12/25 10:43:34 |
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Basic information
Public title
Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.
Acronym
Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.
Scientific Title
Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.
Scientific Title:Acronym
Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm the safety and efficacy of a five-fold daily intake of the test food for four weeks in an exploratory manner.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed).
(Week 0, Week 2, Week 4)
Key secondary outcomes
*Secondary outcomes
1) Physical xamination (Week 0, Week 2, Week 4).
2) Biochemical examination (Week 0, Week 2, Week 4).
3) Doctor's questions (Week 0, Week 2, Week 4).
4) Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (Week 0, Week 2, Week 4).
* Efficacy Exploratory Index
1) Blood and fecal special tests (Week 0, Week 4).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food 5 capsules in a day; 4 weeks).
Interventions/Control_2
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women between 20 and 65 years of age at the time of obtaining consent to participate in the study.
2) Individuals who have relatively hard stools and suffer from mild constipation.
3) Individuals with spontaneous defecation frequency of 3-4 times per week.
4) Individuals who are healthy and have no chronic physical disease including skin disease.
5) Individuals whose written informed consent has been obtained.
6) Individuals who can come to the designated venue for this study and be inspected.
7) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1) Individuals using medical products.
2) Individuals who are 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.
4) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
5) Individuals who are a patient or have a history of or endocrine disease.
6) Individuals who have been diagnosed and are under treatment for functional constipation at a medical institution.
7) Individuals who are determined to have chronic constipation in the diagnostic criteria for chronic constipation.
8) Individuals whose BMI is less than 18.5kg/m2 and over 30kg/m2.
9) Individuals with systolic blood pressure 140 mmHg or higher, diastolic blood pressure 90 mmHg or higher, pulse 85 beats/min or higher.
10) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
11) Individuals who experienced unpleasant feeling during blood drawing.
12) Individuals with drug and food allergies.
13) Individuals who have been regularly using food for specified health use, functional foods, or health foods in the past 3 months or at present.
14) Individuals who have a habit of consuming yogurt and fermented foods rich in lactic acid bacteria.
15) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day).
16) Individuals with possible changes of life style during the test period.
17) Individuals who are pregnant, breastfeeding, or who may become pregnant during the study period.
18) Individuals who participated in other clinical studies in the past 3 months.
19) Individuals who are or whose family is engaged in healthy or functional foods.
20) Individuals judged inappropriate for the study by the principal.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nicorio Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 13 | 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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 13 | Day |
Last modified on
| 2025 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063208
