UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050186 |
|---|---|
| Receipt number | R000057162 |
| Scientific Title | Effects of continuous intake of test foods on bone |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2023/01/31 12:33:46 |
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Basic information
Public title
Effects of continuous intake of test foods on bone
Acronym
Effects of continuous intake of test foods on bone
Scientific Title
Effects of continuous intake of test foods on bone
Scientific Title:Acronym
Effects of continuous intake of test foods on bone
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of the test food to placebo for improving bone density and bone quality during 12 consecutive weeks of intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone metabolism markers (BAP:bone alkaline phosphatase, P1NP, TRACP-5b, NTX)
Key secondary outcomes
Antioxidant markers (BAP:biological antioxidant potential, dROM, urinary 8-OHdG), bone markers (homocysteine, urinary pentosidine), 25OHVD, JOQOL, bone mineral content, and safety
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Consumption of test food once a day for 12 weeks
Interventions/Control_2
Consumption of placebo once a day for 12 weeks
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Japanese female aged 50 to 69 years old who have passed more than one year after natural menopause
(2) BMI 18.5 or more and less than 30.0
(3) Subjects who are concerned about their bone health; for example, subjects whose family members have a history of fractures (femur, tibia, spine) other than fingers
(4) Subjects who consented to participate in this trial in writing with his/her own will after receiving sufficient explanations
Key exclusion criteria
(1) Subjects diagnosed with osteoporosis
(2) Subjects who suffer from the following chronic diseases and under medication:
rheumatism, cerebrovascular disease, arrhythmia under treatment with warfarin, thyroid disease, adrenal gland disease
(3) Subjects with diabetes, hyperlipidemia or hypertension who are poorly controlled by medication
(4) Subjects with hepatic disorder
(5) Subjects with renal disorder
(6) Subjects with serious anemia
(7) Subjects who may cause allergic symptoms to the test food ingredients (polyphenols, gelatin, etc.)
(8) Subjects who may cause serious allergic symptoms due to ingestion of food or medicines
(9) Subjects who suffer from alcoholism or other mental disorder or have such a history
(10) Subjects who take supplements, foods for specified health uses, foods with functional claims, or foods with nutrient function claims that affect bone metabolism once or more per week, such as calcium, vitamin D, vitamin K, magnesium, isoflavones (including daidzein, genistein, equol, etc.)
(11) Subjects who plan to take foods with health claims or supplement foods newly during the study period
(12) Subjects who have received hormone replacement therapy within the past 6 months
(13) Subjects who have suffered a bone injury or illness such as a fracture within the past 6 months
(14) Subjects who have received treatment requiring hospitalization within the past 6 months
(15) Subjects who participated in other human clinical trials within the past 3 months, or those who plan to participate in other human clinical trials during the study period
(16) Subjects judged as unsuitable for the study by the investigator with other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Machiko |
| Middle name | |
| Last name | Nishioka |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Research and development Dept. Central R&D Laboratory
Zip code
567-0057
Address
1-30-3, Toyokawa. Ibaraki, Osaka, Japan
TEL
090-3922-5871
m.nishioka@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Matsuda |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1. Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
Homepage URL
matsuda@ughp-cpc.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital Ethics Review Committee
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel
011-882-0111
matsuda@ughp-cpc.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057162
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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