UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035306 |
|---|---|
| Receipt number | R000040229 |
| 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 10:27:51 |
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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
| Not applicable | 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
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 |
Interventions/Control_1
Intake 3 tablet containing plant extract at the time of metabolism and sleep measurement. single ingestion
Interventions/Control_2
Intake 3 tablets without plant extract at the time of metabolism and sleep measurement. single ingestion
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
| 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
40
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
yanagisawa.masa.fu@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshio Kokubo |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL
029-853-8080
Homepage URL
kokubo.toshio.fp@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
| 2019 | Year | 04 | Month | 01 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040229
| Research Plan | |
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| Registered date | File name |
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