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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035305
Receipt No. R000040228
Scientific Title Confirmation test on sleep and basal metabolism by ingesting rose hip extract
Date of disclosure of the study information 2019/12/18
Last modified on 2018/12/20

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Basic information
Public title Confirmation test on sleep and basal metabolism by ingesting rose hip extract
Acronym Confirmation test on sleep and basal metabolism by ingesting rose hip extract
Scientific Title Confirmation test on sleep and basal metabolism by ingesting rose hip extract
Scientific Title:Acronym 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
1st name
Middle name
Last name Masashi Yanagisawa
Organization University of Tsukuba
Division name International Institute for Integrative Sleep Medicine
Zip code
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
1st name
Middle name
Last name Kokubo Toshio
Organization University of Tsukuba
Division name nternational Institute for Integrative Sleep Medicine
Zip code
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)

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
2019 Year 12 Month 18 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
2018 Year 12 Month 05 Day
Date of IRB
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

Other
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

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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