UMIN-CTR Clinical Trial

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
Email	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
Email	hiroshi-tsukikawa@lta-med.com

Sponsor
Institute	Medical Co. LTA Sugioka Memorial Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054705