UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055337 |
|---|---|
| Receipt number | R000063240 |
| Scientific Title | Research on the Efficacy of Test Foods in Improving Menstrual Symptoms |
| Date of disclosure of the study information | 2024/08/26 |
| Last modified on | 2024/09/26 16:53:08 |
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Basic information
Public title
Research on the Efficacy of Test Foods in Improving Menstrual Symptoms
Acronym
Research on the Efficacy of Test Foods in Improving Menstrual Symptoms
Scientific Title
Research on the Efficacy of Test Foods in Improving Menstrual Symptoms
Scientific Title:Acronym
Research on the Efficacy of Test Foods in Improving Menstrual Symptoms
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of continuous intake of the test food for one menstrual cycle on menstrual symptoms and to determine its usefulness and effective dose in a randomized, double-blind, placebo-controlled, parallel-group trial involving women aged 25 to 40 years with regular menstrual cycles and menstrual symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
PAF short version (total score)
Key secondary outcomes
PAF short version (subscale scores)
PMTS-VAS
POMS-2 adult-short version
Original VAS
OSA sleep inventory MA version
WPAI
Salivary Estradiol and Salivary Progesterone
Stool frequency and shape
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake Test Food-1 for one menstrual cycle and one menstrual period
Interventions/Control_2
Intake Test Food-2 for one menstrual cycle and one menstrual period
Interventions/Control_3
Intake Test Food-3 for one menstrual cycle and one menstrual period
Interventions/Control_4
Intake Test Food-4 for one menstrual cycle and one menstrual period
Interventions/Control_5
Intake the placebo food for one menstrual cycle and one menstrual period
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Women aged 25 to 40 years.
2)Subjects with normal menstrual cycles, defined as the last three menstrual cycles being 25 to 38 days in length and menstrual periods lasting 3 to 7 days.
3)Subjects experiencing menstrual symptoms.
4)Subjects who work at least three days a week.
5)Subjects who can commit to daily consumption of the test food during the test food intake period.
6)Subjects who have been informed about the purpose and details of the study, possess the capacity to consent, understand the information thoroughly, and can provide consent electronically through informed consent.
Key exclusion criteria
1)Subjects currently taking medications that affect menstrual symptoms, excluding those who temporarily take over-the-counter medications for menstrual pain or headache, or laxatives or antidiarrheals only before or during menstruation.
2)Subjects currently receiving medical treatment or medication for premenstrual syndrome, premenstrual dysphoric disorder or dysmenorrhea, other gynecological disorders, thyroid disorders, autonomic nervous system disorders, mental disorders, diabetes, or hyperlipidemia, or those who plan to receive medical treatment or medication during the study period.
3)Subjects with no menstrual pain or those with severe menstrual pain that cannot be controlled by over-the-counter medications.
4)Subjects with a chronic illness currently receiving medical treatment and medication.
5)Subjects at risk of developing an allergy to the test food.
6)Women who are breastfeeding, pregnant, or possibly pregnant, or who intend to become pregnant during the study period.
7)Subjects with a history of cerebrovascular disease, heart disease, liver disease, or kidney disease.
8)Subjects with a history of serious digestive system diseases such as gastrectomy, gastrointestinal suture surgery, or intestinal resection.
9)Subjects whose body weight <45 kg.
10)Subjects whose BMI <18.5 kg/m2 or >= 30 kg/m2.
11)Subjects who currently regularly consume functional foods, or health foods, and cannot stop taking such foods during the study period.
12)Subjects who are heavy smokers or heavy drinkers, and those with extremely irregular eating habits.
13)Subjects whose living environment may change significantly during the study period.
14)Subjects who are currently participating in other clinical trials, have participated in them within the past 8 weeks, or are scheduled to participate in other clinical trials during the study period.
15)Subjects who are otherwise deemed ineligible to participate by the principal investigator's opinions.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Life Science Division Clinical Research Unit
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mori |
Organization
Macromill, Inc.
Division name
Life Science Division Clinical Research Unit
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan
TEL
03-6716-0700
Homepage URL
yuk_mori@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico 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
Institutional review board of Tsukiji Futaba Clinic
Address
Tsukiji 1-9-9, Chuou-ku, Tokyo, Japan, 104-0045
Tel
03-6226-5812
tohru@hikobae.net
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 | 08 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 27 | 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 | 08 | Month | 26 | Day |
Last modified on
| 2024 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063240
