UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054229 |
|---|---|
| Receipt number | R000061910 |
| Scientific Title | Research on the effect of eating chocolate on feeling of tension |
| Date of disclosure of the study information | 2024/04/26 |
| Last modified on | 2024/04/22 15:44:17 |
* 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
Research on the effect of eating chocolate on feeling of tension
Acronym
Research on the effect of eating chocolate on feeling of tension
Scientific Title
Research on the effect of eating chocolate on feeling of tension
Scientific Title:Acronym
Research on the effect of eating chocolate on feeling of tension
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the impact of eating chocolate on feeling of tension, amount of sweating and heart rate during tension-inducing situations
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
subjective evaluation (tension)
Key secondary outcomes
subjective evaluation (restless state, awareness of others, sense of accomplishment), amount of sweating, heart rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Research food are consumed one (standard 4 g) at a time
Interventions/Control_2
Not consuming research food
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 64 years of age
(2) Those who fully understand the purpose and content of the research and agree to participate in the research of their own free will
(3) Those who are aware of being easily tense
(4) Those whose amount of sweating and heart rate during the task shows tension-induced changes
Key exclusion criteria
(1) Those who has sweaty hands and measurement difficulties
(2) Those who are judged to be inappropriate as research subjects (subjects) based on their answers to the lifestyle questionnaire
(3) Those who are judged to be unsuitable as subjects based on the answers to the background survey
(4) Those who are suspected of having depression
(5) Those who may develop allergies in relation to research food
(6) Those who are prescribed or regularly use medications that may affect stress
(7) Those who consume health foods such as specified health foods and functional foods related to stress at least one day per week
(8) Those who doesn't like research food
(9) Those who, due to injury or other reasons, have difficulty in measuring amount of sweating or inputting data into a computer
(10) Those who have a disease that requires constant medication (whether external or internal), those who have a disease under treatment (except for dry eye and dental caries treatment), those who have a history of serious disease that required medication
(11) Those whose physical measurements, physical examination values, and clinical examination values before the examination were significantly out of the reference range
(12) Those who work in shifts, work late at night, and have an irregular daily rhythm
(13) Those who plan to go abroad during the study period, or who plan to make a domestic business trip, domestic travel, or return home during the 3 days prior to the Intake Phase I or Intake Phase II test date
(14) Those who participated in other clinical studies, clinical trials, or human trials within one month prior to the start of this study
(15) Those who plan to become pregnant or breastfeed during the study period
(16) Those who are judged as unsuitable for the study by the investigator for other reason
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Higuchi |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory
Zip code
336-8601
Address
1-1, Numakage 3-chome, Minami-ku, Saitama-shi, Saitama
TEL
048-837-0162
higuchi_hiroaki@lotte.co.jp
Public contact
Name of contact person
| 1st name | Rio |
| Middle name | |
| Last name | Fujiwara |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center Foods Department Section 1
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-7079-8488
Homepage URL
fujiwara.rio605@eps.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.jp
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
メディカルステーションクリニック (Medical station clinic) (東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 06 | 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 | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061910
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
