UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038641 |
|---|---|
| Receipt number | R000042542 |
| Scientific Title | Double blind Study of arabinogalactane derived from Hyuganatsu orange to bone metabolism. |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2020/11/25 15:45:19 |
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Basic information
Public title
Double blind Study of arabinogalactane derived from Hyuganatsu orange to bone metabolism.
Acronym
DB-SAHBo Study (Double blind study of arabinogalactane derived from Hyuganatsu orange to bone metabolism)
Scientific Title
Double blind Study of arabinogalactane derived from Hyuganatsu orange to bone metabolism.
Scientific Title:Acronym
DB-SAHBo Study (Double blind study of arabinogalactane derived from Hyuganatsu orange to bone metabolism)
Region
| Japan |
Condition
Condition
Prevention of the osteoporosis
Classification by specialty
| Obstetrics and Gynecology | Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate serum TRACP5b level before and after taking Hyuganatsu orange juice containing arabinogalactane
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
TRACP5b concentration before and after intake of Hyuganatsu juice
Key secondary outcomes
Effects of BAP, HS-PTH, P1NP and 25hydroxy vitamin D levels after intake of Hyuganatsu juice.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Hyuganatsu juice intake group; Take 125ml of Hyuganatsu juice containing arabinogalactane every day for 90days.
Interventions/Control_2
Take 125ml of Placebo drink, every day for 90days.
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Female
Key inclusion criteria
1) Female at least 5 years after menopause
2) Volunteer after informed consent with written notice
Key exclusion criteria
female with
1) elevated kidney and liver function data
2) suffering some disease that is known to
affect bone metabolism,such as bone fracture, Diabetes mellitus
3) taking medicine that affect bone metabolism, such as steroid, bisphosphonates.
4) allergy to orange.
5) persons who take orange at least one orange everyday within 3 months
6) Others
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
University of Miyazaki
Division name
Department of OB/GYN
Zip code
889-1692
Address
5200 Kihara, Kiyotake-Cho, Miyazaki 889-1692, Japan
TEL
+81985850988
myama@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
University of Miyazaki
Division name
Department of OB/GYN
Zip code
889-1692
Address
5200 Kihara, Kiyotake-Cho, Miyazaki 889-1692, Japan
TEL
+81985850988
Homepage URL
myama@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
MIYAZAKIKEN NOKYO KAJU CO. LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1) SOJO UNIVERSITY Faculty of Biotechnology and Life Science
2) Center for Collaborative Research & Community Cooperation University of Miyazaki
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the University of Miyazaki of Medical Sciences
Address
5200, Kihara, Kiyotkecho, Miyazaki, Japan
Tel
+81-985-85-9403
rinken@med.miyazaki-u.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
宮崎大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 01 | 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
64
Results
Objectives: Postmenopausal women
Intervention: Oral intake of juice with arabinogalactan isolated from Hyuganatsu orange.
Control: Placebo drink.
Primary outcome; Difference of Tartrate-resistant Acid Phosphatase 5b (TRACP5b).
Statistics; Two-way repeated measure analysis of variance with Bonferroni's post hoc test
Results; TRACP5b level was significantly lower in study group.
Conclusion; Taking Hyuganatsu orange juice containing arabinogalactan is useful for bone health in postmenopausal women.
Results date posted
| 2020 | Year | 09 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Volunteer was recruited with local community announcement magazine. Inclusion criterion is postmenopausal women at least 5 years after menopause. Informed consent was taken and blood collection was performed. Finally, 64 women were enrolled. Average age was 67 years old (51~88) and average post menopause duration was 16 years (6~38yeasrs).
Participant flow
After enrollment, one women declined permission due to personal reason. Therefore, 63 women were randomized. Number of intervention group was 31 and control group was 32. Two women (one intervention group and one control group) had accidentally slip down and bone fracture were occurred. Therefore, we analyzed data in 30 intervention group and 31 control group
Adverse events
volunteer was recruited with local community announcement magazine. Inclusion criterion is postmenopausal women at least 5 years after menopause. We reported serious adverse event (SAE) report to Ethics Committee of Faculty of Medicine University of Miyazaki. Ethical committee confirmed our adverse event was an accident and there was no relationship to study protocol.
Outcome measures
1) Primary outcome
A two-way repeated measure analysis of variance (ANOVA) with Dunnet's post hoc statistical testing was used to determine measurement variables before and after administration of Hyuganatsu.
Serum TRCP5b time course was significantly suppressed in study group when compared with control group.
2) Additional outcomes
Using same procedure, serum P1NP time course was significantly suppressed in study group. There was no significant difference in ucOC, BAP, i-PTH, 25OHD.
Plan to share IPD
there is no plan
IPD sharing Plan description
nothing to note
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 28 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 02 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 20 | Day |
Last modified on
| 2020 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042542
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