UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033180 |
|---|---|
| Receipt number | R000037837 |
| Scientific Title | A trial evaluating the efficacy of paprika oleoresin intake on bone metabolism: A randomized, placebo-controlled, double-blind, parallel-group comparison trial. |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2020/10/13 09:21:02 |
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Basic information
Public title
A trial evaluating the efficacy of paprika oleoresin intake on bone metabolism: A randomized, placebo-controlled, double-blind, parallel-group comparison trial.
Acronym
A trial evaluating the efficacy of paprika oleoresin intake on bone metabolism
Scientific Title
A trial evaluating the efficacy of paprika oleoresin intake on bone metabolism: A randomized, placebo-controlled, double-blind, parallel-group comparison trial.
Scientific Title:Acronym
A trial evaluating the efficacy of paprika oleoresin intake on bone metabolism
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of paprika oleoresin intake on bone metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bone resorption markers; NTX, TRACP-5b (baseline, 12, 24 weeks)
Key secondary outcomes
Bone formation markers; BAP, OC (baseline, 24 weeks)
Safety evaluation; Physical examinations, Hematological tests, Blood biochemistry tests, Urinalysis (baseline, 12, 24 weeks)
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 24 weeks
Test material: Soft capsule containing 20 mg of paprika oleoresin
Dose: One capsule per day
Administration: Take the capsule with water or warm water after breakfast
* If you forget to take the capsule, take it as soon as you remember within the day.
Interventions/Control_2
Duration: 24 weeks
Test material: Placebo soft capsule
Dose: One capsule per day
Administration: Take the capsule with water or warm water after breakfast
* If you forget to take the capsule, take it as soon as you remember within the day.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
a) Healthy Japanese women.
b) Subjects who are in menopause (natural menopause) for at least 1 year.
c) Subjects who are judged as eligible to participate in the study by the physician.
Key exclusion criteria
a) Subjects who are diagnosis with osteoporosis (Subjects who have less than 70% in total amount of bone mineral density for lumbar vertebra of YAM score).
b) Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction.
c) Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases.
d) Subjects who take supplements, "Foods for Specified Health Uses," "Foods with Functional Claims," or "Foods with Nutrient Function Claims" related to bone metabolism such as calcium, vitamin D, vitamin K, magnesium, and isoflavones (including daidzein, genistein, equol, or etc.) more than once a week.
e) Subjects who are currently taking medications (including herbal medicines) and supplements.
f) Smoker
g) Subjects who are allergic to medicines and/or the test food related products.
h) Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial.
i) Subjects who are judged as ineligible to participate in the study by the physician.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Riken Vitamin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Riken Vitamin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
ORTHOMEDICO Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Seishinkai, Takara Clinic
Address
9F Taisei Bldg, 2-3-2 Higashi-Gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3622
info@takara-clinic.com
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
医療法人社団盛心会タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.29219/fnr.v64.4565
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.29219/fnr.v64.4565
Number of participants that the trial has enrolled
100
Results
The percentage decrease of TRACP-5b at 24 weeks was significantly higher for paprika oleoresin than the placebo. There were no significant differences in sNTX or bone formation markers, although paprika oleoresin decreased each marker compared with the placebo.
Results date posted
| 2020 | Year | 10 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 10 | Month | 05 | Day |
Baseline Characteristics
paprika oleoresin group
Age(years), 56.3(6.1); Height(cm), 157.4(4.5); Weight(kg), 51.6(4.8)
placebo group
Age(years), 56.9(5.8); Height(cm), 157.0(4.7) ; Weight(kg), 53.4(8.8)
Values are expressed as mean(SD).
Participant flow
A total of 140 potential participants were initially screened, and 100 were enrolled in the study. Participants were randomly allocated (1:1) to one of two groups. One participant in the placebo group did not receive the allocated intervention due to consent withdrawal, and one participant in the placebo group did not complete all of the clinical visits for personal reasons. Four participants in the paprika oleoresin group and three participants in the placebo group were eliminated from the analysis due to poor compliance (i.e., frequently forgetting to take the test supplements and writing in the daily diary).
Adverse events
No adverse effect was observed related to the paprika oleoresin.
Outcome measures
Percentage change in bone turnover markers from baseline to the end of the intake period (24 weeks).
TRACP-5b(%)
Paprika oleoresin(PO) group, -2.3(2.3); placebo group, 5.5(2.8); P = 0.037
sNTX(%)
PO group, -8.4(1.8); placebo group, -6.8 (2.4); P = 0.595
BAP(%)
PO group, 9.1(2.7); placebo group, 12.2(2.3); P = 0.386
OC(%)
PO group, -6.6(2.5); placebo group, -4.6(2.6); P = 0.599
Values are expressed as mean(SD).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 29 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 28 | Day |
Last modified on
| 2020 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037837
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