UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056650 |
|---|---|
| Receipt number | R000064751 |
| Scientific Title | Research on the effectiveness of the My Asa Program |
| Date of disclosure of the study information | 2025/01/07 |
| Last modified on | 2025/07/08 09:18:33 |
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Basic information
Public title
Research on the effectiveness of the My Asa Program
Acronym
Research on the effectiveness of the My Asa Program
Scientific Title
Research on the effectiveness of the My Asa Program
Scientific Title:Acronym
Research on the effectiveness of the My Asa Program
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the effects of the "My Asa Program" on gut health improvement when implemented for 60 days in healthy Japanese men and women aged 18 to under 65.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal microbiome
Key secondary outcomes
Fecal metabolome analysis
Questionnaire on gut health
Questionnaire on lifestyle
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects will follow the designated My Asa program (diet, water intake, exercise, and lifestyle guidance) for 60 days and take supplements assigned to Group I or Group II.
Group I: Each morning, one packet each of supplements (1) and (2) will be taken.
Interventions/Control_2
Group II: In addition to the Group I program, 10 g of supplement (3) will be taken every morning and 6 capsules of supplement (4) will be taken each morning and evening.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Persons who have been fully informed of the purpose and content of this research, have the capacity to consent, fully understand, and freely and voluntarily volunteer to participate in this research, and agree to participate in the study.
2.Persons who are Japanese men and women aged 18 to under 65 at the time of obtaining consent.
Key exclusion criteria
1.Persons who are receiving medication for a chronic disease or have a history of a serious disease.
2.Persons who are allergic to any of the foods in the study.
3.Persons who are taking antibiotics or undergoing colonoscopy in 2 weeks prior to and during the study.
4.Persons who are taking supplements or protein supplements on a regular basis.
5.Persons who are regularly taking medicines or health foods (food for specified health use, food with functional claims, food with nutrient function claims), etc. that may affect the intestinal environment.
6.Persons who have participated in other studies during one month prior to the start of this study, or who plan to participate in other studies after consenting to this study.
7.Persons who are judged to be ineligible by the supervising doctor or the principal investigator.
8.Persons who are lactating, pregnant, or planning or wishing to become pregnant during the study period.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
masudat@hc-sys.jp
Public contact
Name of contact person
| 1st name | Haruna |
| Middle name | |
| Last name | Yamashita |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
Yamashita.haruna@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Amway Japan G.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
HEM Pharma Inc
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2025 | Year | 01 | Month | 07 | 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
75
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 | 12 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 07 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064751
