UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046979 |
|---|---|
| Receipt number | R000053588 |
| Scientific Title | A confirmatory study on the effect of continuous intake of test food on bone metabolism. -A placebo-controlled, randomized, double-blind clinical trial- |
| Date of disclosure of the study information | 2022/02/27 |
| Last modified on | 2024/06/25 16:05:43 |
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Basic information
Public title
A confirmatory study on the effect of continuous intake of test food on bone metabolism. -A placebo-controlled, randomized, double-blind clinical trial-
Acronym
A confirmatory study on the effect of continuous intake of test food on bone metabolism.
Scientific Title
A confirmatory study on the effect of continuous intake of test food on bone metabolism. -A placebo-controlled, randomized, double-blind clinical trial-
Scientific Title:Acronym
A confirmatory study on the effect of continuous intake of test food on bone metabolism.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effectiveness and safety of continuous intake of test food for 24-weeks on bone metabolism in healthy females with decreased bone metabolic functions aged between 50 and less than 70 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood bone metabolism-related markers
Bone mineral density
Key secondary outcomes
Blood metabolism assessment markers
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
Take one packet of the test food with water, warm water, green tea, or coffee before breakfast once a day. Dissolving the food in these solutions will be allowed.
Interventions/Control_2
Take one packet of the placebo food with water, warm water, green tea, or coffee before breakfast once a day. Dissolving the food in these solutions will be allowed.
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. Aged between 30 and less than 59 years old.
2. Japanese females.
3. Have anxiety about bone health.
4. BMI between 18.5 and 29.5 kg/m^2.
5. Can use smartphones or PCs to input an electronic diary.
6. Received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.
Key exclusion criteria
1. Currently undergoing treatment for any disease, or receive medical treatment such as medical drugs or traditional Chinese medicines. Medications used as needed are acceptable.
2. Receiving nutritional and exercise therapy by medical doctors.
3. Have severe diseases or a history of severe diseases.
4. Received hormone replacement therapy within six months before the study.
5. Have experienced bone-related diseases such as bone fracture within six months before the study.
6. Have artificial materials or foreign substances in the bones with surgeries or any reason.
7. Have the Young Adult Mean% less than 70%.
8. Received barium swallow test within 7 days before the day of visit.
9. Have currently been taking commercially available drugs, quasi-drug products, foods, or supplements with any functional claims. However, can discontinue taking these drugs/foods during the trial period is acceptable to join the study.
10. Have allergies to drugs or foods.
11. Planning extremely change lifestyle (such as diet, sleep, or exercise) during the study period.
12. Planning travel to foreign countries during the study period.
13. Taking more than 60 g alcohol/day.
14. Smoking within one year before the trial.
15. Individuals who joined other clinical trials from one month before the trial, individuals who have currently been joined other clinical trials, and also Individuals who are planning to join other clinical trials during the trial.
16. Unsuitable for the study, that judged by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yo |
| Middle name | |
| Last name | Matsumoto |
Organization
Jellice Co., Ltd.
Division name
Development group, Technical center
Zip code
985-0833
Address
4-4-1 Sakae Tagajo-shi Miyagi, 984-0826, Japan
TEL
022-361-8821
matsumoto@jellice.com
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo, 104-0061, Japan
TEL
03-6704-5968
Homepage URL
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Jellice 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.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
| 2022 | Year | 02 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 22 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053588
