UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022122 |
|---|---|
| Receipt number | R000025478 |
| Scientific Title | Study for the evaluation of the effect of the indigestible dextrin on PMS (Premenstrual Syndrome) symptoms |
| Date of disclosure of the study information | 2016/05/02 |
| Last modified on | 2017/01/08 13:44:11 |
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Basic information
Public title
Study for the evaluation of the effect of the indigestible dextrin on PMS (Premenstrual Syndrome) symptoms
Acronym
The effect of the indigestible dextrin on PMS
Scientific Title
Study for the evaluation of the effect of the indigestible dextrin on PMS (Premenstrual Syndrome) symptoms
Scientific Title:Acronym
The effect of the indigestible dextrin on PMS
Region
| Japan |
Condition
Condition
Premenstrual syndrome
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of the indigestible dextrin on relief of PMS symptom due to slowing the postprandial elevation of blood glucose levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
symptoms from the first day of menstrual period to next period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intervention: to drink indigestible dextrin-containing green tea at each meal during a menstrual cycle
5.12g of indigestible dextrin at each meal
Interventions/Control_2
Control: to drink indigestible dextrin-free green tea at each meal during a menstrual cycle
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
females who have a regular menstrual cycle
females who do not have a low-dose pill
females who is more than 20 years of age and older
Key exclusion criteria
females who have an irregular menstrual cycle
females who take a low-dose pill
females who have no symptom
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Ohta |
Organization
International College of Arts and Sciences
Fukuoka Women's University
Division name
Department of Food and Health Sciences
Zip code
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka
TEL
+81-92-661-2411
m-ohta@fwu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Ohta |
Organization
International College of Arts and Sciences, Fukuoka Women's University
Division name
Department of Food and Health Sciences
Zip code
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka
TEL
+81-92-661-2411
Homepage URL
m-ohta@fwu.ac.jp
Sponsor or person
Institute
Fukuoka Women's University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 05 | Month | 02 | 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
There is no significant effect of indigestible dextrin on the symptoms of PMS.
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
| 2016 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 27 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 24 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 28 | Day |
Last modified on
| 2017 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025478
