UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054782 |
|---|---|
| Receipt number | R000062599 |
| Scientific Title | A study for the effects of long-term consumption of chocolate on premenstrual dysphoric disorder: a randomized, open-label, parallel-group comparison study |
| Date of disclosure of the study information | 2024/06/28 |
| Last modified on | 2025/07/15 15:44:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study for the effects of long-term consumption of chocolate on premenstrual dysphoric disorder
Acronym
A study for the effects of long-term consumption of chocolate on premenstrual dysphoric disorder
Scientific Title
A study for the effects of long-term consumption of chocolate on premenstrual dysphoric disorder: a randomized, open-label, parallel-group comparison study
Scientific Title:Acronym
A study for the effects of long-term consumption of chocolate on premenstrual dysphoric disorder
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of long-term consumption of chocolate on temporary premenstrual discomfort
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Total scores of the Menstrual Distress Questionnaire (MDQ) during the pre-intervention phase (follicular and luteal phases) and intervention phase (follicular and luteal phases)
Key secondary outcomes
1. Original questionnaire (appetite, sleepiness, mood) during pre-intervention phase (follicular and luteal phases) and intervention phase (follicular and luteal phases)
2. Autonomic indices coefficient of variation of R-R intervals (CVRR) and standard deviation of normal-to-normal interval (SDNN), heart rate, sleep duration, habitual sleep efficiency, and sleep stages and their durations during pre-intervention phase (follicular and luteal phases) and intervention phase (follicular and luteal phases)
3. The score of each scale (Pain, Water Reten, Auto React, Negative affect, Impair Conc, Behave Change, Arousal, Control) and each item in the MDQ during pre-intervention phase (follicular and luteal phases) and intervention phase (follicular and luteal phases)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: One menstrual cycle
Test food: Chocolate
Administration: Take 32 g of chocolate per day in two divided doses.
Interventions/Control_2
Duration: One menstrual cycle
No treatment
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1. Japanese
2. women
3. Individuals aged 20 or more and less than 40 at the time of agreement to participate in this study (who won't be 40 during the study)
4. Healthy individuals without disease on outpatient visits at screening (before consumption; Scr)
5. Individuals whose menstrual cycle lasts at least 25 days and at most 35 days
6. Individuals whose total score of MDQ is 30 or more at Scr (luteal phase)
7. Individuals who have a smartphone device on which the application can be installed, who do not plan to change their device during the study, and who agree with the terms of use for the wearable device and application used in this study
8. Individuals who have given written consent to participate in this study and have provided their information prior to participation
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Individuals who have a pacemaker, an implantable cardioverter defibrillator (ICD), or a device that can affect heart rate
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who are taking medications (including herbal medicines) and supplements, particularly who take medications that can affect heart rate
6. Individuals who take chocolate (including quasi-chocolate) every day
7. Individuals who are allergic to medicines and/or foods related to the test product, particularly who show allergic reactions to chocolate, milk, soybeans, eggs, wheat
8. Individuals who are pregnant, lactating, or planning to become pregnant during this study
9. Individuals who are taking hormonal drugs (such as the pill) or antipsychotics within 2 months prior to participation, or who have been diagnosed with other psychiatric disorders and gynopathy
10. Individuals who may develop skin reaction or other skin problems due to continuous use of wearable devices
11. Individuals who have not had menses for more than 3 months, or who are postmenopausal
12. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study
13. Individuals who are judged that have difficulty using the wearable device in the study by the principal investigator
14. Individuals who work a late-night shift
15. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Kosaku |
| Middle name | |
| Last name | Kawada |
Organization
TechDoctor, Inc.
Division name
Business Development Department
Zip code
104-0031
Address
4F Kyobashi Edogrand, Kyobashi 2-2-1, Chuo-ku, Tokyo, Japan
TEL
03-5476-8889
Homepage URL
kawada@technology-doctor.com
Sponsor or person
Institute
TechDoctor, Inc.
Institute
Department
Personal name
Funding Source
Organization
LOTTE CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
ORTHOMEDICO Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 28 | 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
110
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 | 06 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 17 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 28 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062599
