UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055575 |
|---|---|
| Receipt number | R000063461 |
| Scientific Title | Effects of consumption of the test food on psychological and physical condition in menopausal women |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2024/09/18 15:04:41 |
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Basic information
Public title
Effects of consumption of the test food on psychological and physical condition in menopausal women
Acronym
Effects of consumption of the test food on psychological and physical condition in menopausal women
Scientific Title
Effects of consumption of the test food on psychological and physical condition in menopausal women
Scientific Title:Acronym
Effects of consumption of the test food on psychological and physical condition in menopausal women
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on psychological and physical condition in menopausal women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS2 Japanese version
Key secondary outcomes
Simplified Menopausal Index, OSA sleep inventory MA version, VAS (fatigue sensation, shoulder stiffness, coldness, eyestrain, dry mouth), vision test, urinary equol, urinary oxidative stress (TBARS, 8-OHdG), salivary stress marker (cortisol, sIgA, oxytocin), saliva production
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily intake of test food X for 12 weeks
Interventions/Control_2
Daily intake of test food Y for 12 weeks
Interventions/Control_3
Daily intake of test food Z for 12 weeks
Interventions/Control_4
Daily intake of placebo food for 12 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Females aged 40 or more and 64 or less
2) Subjects whose SMI total score of 50 or less
3) Subjects who experience stress, low mood or fatigue in their daily life
4) Subjects who can give informed consent to participate in this study
Key exclusion criteria
1)Subjects who are allergic to the test food
2)Subjects who are undergoing medical treatment of gynecological such as climacteric disorder and dysmenorrhea
4) Subjects who are undergoing medical treatment of mental disease
5) Subjects who undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
6)Subjects who are constantly taking pill or herbal medicines
7)Subjects who are undergoing hormone replacement therapy
8) Subjects who have a history of ovariectomy or hysterectomy
9) Subjects who consume 50mg or more of soy isoflavones on a daily basis
10) Subjects who have passed more than 5 years after menopause
11) Subjects who take health food (supplement or "Foods with functional claims" or "Food for specified health uses") affecting fatigue, stress or sleep quality
12) Subjects who are pregnant or lactating, or intending to become pregnant during the study
13) Subjects who took part in another clinical study within 28 days prior to the start of the present study or who is currently taking part in another clinical study
14) Subjects who are judged as ineligible to participate in this study by the principal investigator
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Toshinari |
| Middle name | |
| Last name | Maruo |
Organization
Fujicco Co., Ltd
Division name
Innovation center
Zip code
6508558
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-303-5385
t-maruo@fujicco.co.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Aiso |
Organization
Fujicco Co., Ltd.
Division name
Innovation center
Zip code
6508558
Address
6-13-4 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-303-5385
Homepage URL
c-aiso@fujicco.co.jp
Sponsor or person
Institute
Fujico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Fujicco Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Naoko Ishiwata (Faculty of Management Department of Life Environments Management, Atomi University)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Matsumoto Health Lab
Address
1-18-1, Chuo, Matsumoto, Nagano
Tel
0263-39-1139
info@m-health-lab.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
一般財団法人松本ヘルス・ラボ（長野県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 01 | 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
104
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000063461
