UMIN-CTR Clinical Trial

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
Email	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
Email	yosinaka@kyotogakuen.ac.jp

Sponsor
Institute	Kyoto University of Advanced Sience
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	Kyoto University of Advanced Sience
Address	1-1 Nanjo-Otani, Sogabe, Kameoka, Kyoto, Japan
Tel	0771-29-3409
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037005