UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047989 |
|---|---|
| Receipt number | R000054705 |
| Scientific Title | Effect of a functional food ingredient on water retention symptoms in women with water retention symptoms in the luteal phase: a randomized, double-blind, placebo-controlled pilot study |
| Date of disclosure of the study information | 2022/06/10 |
| Last modified on | 2022/06/08 14:55:49 |
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Basic information
Public title
Effect of a functional food supplementation on premenstrual water retention symptoms in women: a randomized, double-blind, placebo-controlled pilot study
Acronym
Effect of a functional food supplementation on water retention symptoms
Scientific Title
Effect of a functional food ingredient on water retention symptoms in women with water retention symptoms in the luteal phase: a randomized, double-blind, placebo-controlled pilot study
Scientific Title:Acronym
Effect of a functional food supplementation on water retention symptoms
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of continuous supplementation of a functional food ingredient on reducing premenstrual symptoms in premenopausal healthy women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS scores of premenstrual symptoms on day 6, 7 and 8 of supplementation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of a functional food ingredient, twice a day for 7 to 15 days
Interventions/Control_2
Oral intake of placebo, twice a day for 7 to 15 days
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Premenopausal healthy women with normal menstrual cycle
2) Individuals who have cyclically onset or worsening of water retention symptoms during the luteal phase
3) Individuals who be able to understand the procedures
4) Individuals who agree to participate in the study by signing the informed consent
Key exclusion criteria
1) Individuals who are pregnant, breast-feeding or intending to become pregnant
2) Individuals who have or had a history of an acute or chronic severe condition
3) Individuals who have a clinically relevant finding on the physical examination or blood testing
4) Individuals who take any continuous medications or dietary supplements
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Hamada |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuthicals Research Institute
Zip code
842-0195
Address
5006-5 Omagari, Yoshinogari, Kanzaki, SAGA
TEL
0952-52-1522
Hamada.Koichiro@otsuka.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Tsukikawa |
Organization
Medical Co. LTA Sugioka Memorial Hospital
Division name
Planning and Coordination Dept
Zip code
813-0017
Address
3-5-1, Kashiiteriha, Higashi-ku, FUKUOKA
TEL
092-662-3608
Homepage URL
hiroshi-tsukikawa@lta-med.com
Sponsor or person
Institute
Medical Co. LTA Sugioka Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
Hakata Clinic Institutional Review Board
Address
Random Square 5 - 7F 6-18, Tenyamachi, Hakata-ku, Fukuoka
Tel
092-283-7701
miyako-koga@lta-med.com
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
| 2022 | Year | 06 | Month | 10 | 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
51
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The analysis has not been completed.
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
| 2014 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 08 | Day |
Last modified on
| 2022 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054705
