UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Confirmation test on sleep and basal metabolism by ingesting rose hip extract
Title of the study (Brief title)	Confirmation test on sleep and basal metabolism by ingesting rose hip extract
Region	Japan

Condition
Condition	Healthy adult male
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Elucidation of effects on energy metabolism and sleep of rose hip extract ingestion
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of each sleep stage by PSG Energy metabolism indicator
Key secondary outcomes	Sleep arousal evaluation by sleep diary Sleep arousal evaluation by activity meter Power value by frequency analysis of sleep brain waves Sleep evaluation at waking time Heart rate and heart rate variability measurement Measurement of body composition Urinary nitrogen emissions Incidence of side effects Incidence of adverse events

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake 1 tablet containing plant extract and 2 tablets without plant extract at the time of metabolism and sleep measurement. single ingestion.
Interventions/Control_2	Intake 3 tablet containing plant extract at the time of metabolism and sleep measurement. single ingestion.
Interventions/Control_3	Intake 3 tablets without plant extract at the time of metabolism and sleep measurement. single ingestion.
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	60 years-old >
Gender	Male
Key inclusion criteria	Subjects who males aged 20 years and under 60
Key exclusion criteria	1) Subjects who systolic blood pressure is 90 mmHg or less 2) Subject who participating in other test or within 4 weeks after participating in another test 3) Subjects who falls under any of the following items. a) Subjects who having a disease in the heart, liver, kidney, stomach (gastric acid secretion, gastric ulcer) (including complications of other diseases) b) Subjects with a history of cardiovascular disease c) Subjects who develop diabetes d) Subjects who are allergic to the test food 4) Claustrophobic subjects 5) Subjects who have been judged as unsuitable for the study by the principal investigator 6) Subjects who regularly use medicines, foods for specified health uses, functional foods and / or supplements 7) Subjects who have a remarkable history of liver dysfunction, renal dysfunction, cardiovascular disease 8) Subjects who aged 60 and over and under 20 9) Subjects who have been treated for psychiatric disorders or sleep disorders so far, those who currently have symptoms to be treated 10) Subjects who are living irregularly 11) Subjects who are body types of lean type (BMI less than 18.5) or obese type (BMI 25 or more) 12) Subjects who engaged in night shift (after 22 o'clock) within the past 3 months 13) Subjects who has traveled to a country with a time difference of 3 hours or more within the past 3 months 14) Subjects who drinking alcohol daily 15) Subjects with smoking habits 16) Subject who intake caffeine per serving is 300 mg or more a day. 17) Subjects with a score of 30 in the morning / night type questionnaire (obvious night type) or 70 points (clear morning) 18) Subjects with an Epworth Sleepiness Scale score of 11 or higher 19) Sleep studies in Pittsburgh Subjects with a score of 5.5 or higher 20) Subjects weighing 36.3 kg or less 21) Subjects who have vomiting reflex abnormalities 22) Subjects transplanting electronic devices such as pacemakers
Target sample size	10

Research contact person
Name of lead principal investigator	Masashi Yanagisawa
Organization	University of Tsukuba
Division name	International Institute for Integrative Sleep Medicine
Address	Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL	029-853-3301
Email	yanagisawa.masa.fu@u.tsukuba.ac.jp

Public contact
Name of contact person	Kokubo Toshio
Organization	University of Tsukuba
Division name	nternational Institute for Integrative Sleep Medicine
Address	Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL	029-853-8080
Homepage URL
Email	kokubo.toshio.fp@u.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2019 Year 12 Month 18 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 12 Month 05 Day
Anticipated trial start date	2018 Year 12 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 12 Month 18 Day
Last modified on	2018 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040228