UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032451 |
|---|---|
| Receipt number | R000037005 |
| Scientific Title | Verification of the effect of Capsicum extract intake on behavioral and psychological parameters and temperature sensation of the body |
| Date of disclosure of the study information | 2018/12/31 |
| Last modified on | 2020/05/02 15:13:12 |
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Basic information
Public title
Verification of the effect of Capsicum extract intake on behavioral and psychological parameters and temperature sensation of the body
Acronym
Verification of the effect of Capsicum extract in healthy adults
Scientific Title
Verification of the effect of Capsicum extract intake on behavioral and psychological parameters and temperature sensation of the body
Scientific Title:Acronym
Verification of the effect of Capsicum extract in healthy adults
Region
| Japan |
Condition
Condition
healthy adult male and females
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of Capsicum extract intake on the physical activity level, health-related QOL, vitality/feeling of exhaustion, and sense of cold
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity level: step count, METs,
Health-related QOL: MOS 36-item short form (SF-36)
Key secondary outcomes
Vitality and Feeling of exhaustion:
Short form of Profile of Mood Status (POMS) 2
Temperature sensation: Temperature sense VSA scale
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Investigational food: 9 mg of Capsicum extract taken daily in 2 divided doses
The step count in daily life is recorded using an activity meter. The study period is 12 weeks.
Interventions/Control_2
Reference food: Placebo is taken 2 times a day.
The step count in daily life is recorded using an activity meter. The study period is 12 weeks.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who are willing to observe the protocol and have consented to participation in the study.
Those who have participated in fitness measurement events sponsored by Kyoto Gakuen University and consented to the use of the fitness data for research.
Those capable of oral intake.
Key exclusion criteria
Those who meet any of the following criteria are excluded from subjects.
Those allergic to Capsicum
Those regularly taking nutritional foods reported to affect energy metabolism
Those regularly taking nutritional foods reported to be effective for maintaining the body temperature
Those with a high fitness age score calculated from 5 fitness measurement items
Those with a BMI <18.5 kg/m2
Those with a surgical disorder (fracture, torn muscle)
Those using a walking aid
Those instructed to restrict exercise by an orthopedist
Those who have been diagnosed to have depression
Other than the above judged to be inappropriate as subjects by investigators responsible for the study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Misaka |
| Middle name | |
| Last name | Kimura |
Organization
Kyoto University of Advanced Sience
Division name
Institute of Interdisciplinary Research
Zip code
621-855
Address
1-1 Nanjo-Otani, Sogabe, Kameoka, Kyoto, Japan
TEL
090-4299-6491
kimura.misaka@kuas.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Yokoyama |
Organization
Kyoto University of Advanced Sience
Division name
Institute of Interdisciplinary Research
Zip code
621-855
Address
1-1 Nanjo-Otani, Sogabe, Kameoka, Kyoto, Japan
TEL
0771-29-2354
Homepage URL
yosinaka@kyotogakuen.ac.jp
Sponsor or person
Institute
Kyoto University of Advanced Sience
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO CO.,INC
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
Kyoto University of Advanced Sience
Address
1-1 Nanjo-Otani, Sogabe, Kameoka, Kyoto, Japan
Tel
0771-29-3409
shibata.masamitsu@kuas.ac.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 31 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 01 | Day |
Last modified on
| 2020 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037005
| Research Plan | |
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| Registered date | File name |
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