UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000033180
Receipt No. 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 (Ver. 10)

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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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute Riken Vitamin Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037837