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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032451
Receipt No. 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 2018/05/01

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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
Middle name
Last name Misaka Kimura
Organization Kyoto Gakuen University
Division name Faculty of Health and Medical Sciences
Zip code
Address 1-1 Nanjo-Otani, Sogabe, Kameoka, Kyoto, Japan
TEL 0771-56-8930
Email misaka@kyotogakuen.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiichi Yokoyama
Organization Kyoto Gakuen University
Division name Faculty of Economics and Business Administration
Zip code
Address 1-1 Nanjo-Otani, Sogabe, Kameoka, Kyoto, Japan
TEL 0771-29-2354
Homepage URL
Email yosinaka@kyotogakuen.ac.jp

Sponsor
Institute Kyoto Gakuen University
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 05 Day
Last follow-up date
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
2018 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037005

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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