UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046111 |
|---|---|
| Receipt number | R000052585 |
| Scientific Title | Confirmation of calcium absorption promoting action in mannooligosaccharides |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2023/04/25 07:12:35 |
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Basic information
Public title
Confirmation of calcium absorption promoting action in mannooligosaccharides
Acronym
Confirmation of calcium absorption promoting action in mannooligosaccharides
Scientific Title
Confirmation of calcium absorption promoting action in mannooligosaccharides
Scientific Title:Acronym
Confirmation of calcium absorption promoting action in mannooligosaccharides
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to confirm the promotion of calcium absorption by mannooligosaccharides intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Excreted urinary calcium
Key secondary outcomes
Urinary deoxypyridinoline
Urinary NTx
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test drink 1 once a day for 1week
Interventions/Control_2
Intake of test drink 2 once a day for 1week
Interventions/Control_3
Intake of placebo drink once a day for 1week
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Healthy female aged 20-70 years
(2)Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to consent, have well understood, volunteered to participate, and have signed the informed consent document
Key exclusion criteria
(1)Subjects who affected from chronic illness and are taking drugs
(2)Subjects who have bone-related diseases
(3)Subjects who have a medical history of diseases such as malignant tumor, heart failure, myocardial infarction, arrhythmia, liver dysfunction, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, urinary stones, etc.
(4)Subjects who are taiking supplements (including foods for specified health use and foods with functional claims)
(5)Subjects who regularly drink milk
(6)Subjects working in night shifts
(7)Subjects who who always have diarrhea
(8)Subjects who have a history of gastrointestinal disorders and gastrointestinal surgery that affect gastrointestinal absorption
(9)Subjects who have allergies to food ingredients contained in test foods
(10)Subjects who are pregnant, breastfeeding, or willing to become pregnant
(11)Subjects who have collected more than 200 mL of blood within 12 weeks prior to the screening test
(12)Subjects who participate in other clinical trials (food, pharmaceuticals and cosmetics), who have participated in other tests within one month of obtaining consent, or who are willing to participate
(13)Subjects who are judged as unsuitable for the study by the investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 12-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Kumao |
Organization
Ajinomoto AGF, INC.
Division name
Technology Development Dept. Technical Research and Development Institute
Zip code
210-8681
Address
1-1, Suzuki-cho Kawasaki-ku, Kawasaki-shi Kanagawa Pref.
TEL
080-3721-4520
Homepage URL
toshio.kumaoh.hv8@agf.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto AGF, INC.
Technology Development Dept.
Technical Research and Development Institute
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2, Gokanmachi, maebashishi, Gunma
Tel
027-261-7600
sagawa@mc-connect.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 | 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
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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 18 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052585
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
