UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053417 |
|---|---|
| Receipt number | R000060935 |
| Scientific Title | A Double-Blind, Cross-over Study on Effect of the Single Ingestion of Milk Proteins and Milk Oligosaccharide on Mineral Absorption. |
| Date of disclosure of the study information | 2024/01/25 |
| Last modified on | 2024/01/23 13:35:06 |
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Basic information
Public title
A Double-Blind, Cross-over Study on Effect of the Single Ingestion of Milk Proteins and Milk Oligosaccharide on Mineral Absorption.
Acronym
Effect of the Single Ingestion of Milk Proteins and Milk Oligosaccharide on Mineral Absorption.
Scientific Title
A Double-Blind, Cross-over Study on Effect of the Single Ingestion of Milk Proteins and Milk Oligosaccharide on Mineral Absorption.
Scientific Title:Acronym
Effect of the Single Ingestion of Milk Proteins and Milk Oligosaccharide on Mineral Absorption.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove clinical benefits associated with single ingestion of milk proteins and milk oligosaccharide on mineral absorption in a randomized, double-blind, crossover study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area Under the Curve of Urinary mineral (Ca, Mg, Fe, Zn) /creatinine ratio
Key secondary outcomes
Urinary mineral (Ca, Mg, Fe, Zn) /creatinine ratio
Calcitonine in blood
Urinary NTx/creatinine ratio
Urinary DPD/creatinine ratio
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
YES
Concealment
Central registration
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of test food A
- Washout period
- Single ingestion of test food B
- Washout period
- Single ingestion of test food C
*Test food A: Dextrins and minerals
*Test food B: Dextrins, minerals, and milk proteins
*Test food C: Dextrins, minerals, milk proteins, and milk oligosaccharide
Interventions/Control_2
Single ingestion of test food A
- Washout period
- Single ingestion of test food C
- Washout period
- Single ingestion of test food B
Interventions/Control_3
Single ingestion of test food B
- Washout period
- Single ingestion of test food A
- Washout period
- Single ingestion of test food C
Interventions/Control_4
Single ingestion of test food B
- Washout period
- Single ingestion of test food C
- Washout period
- Single ingestion of test food A
Interventions/Control_5
Single ingestion of test food C
- Washout period
- Single ingestion of test food A
- Washout period
- Single ingestion of test food B
Interventions/Control_6
Single ingestion of test food C
- Washout period
- Single ingestion of test food B
- Washout period
- Single ingestion of test food A
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1. Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent.
2. Post-menopausal Japanese women.
Key exclusion criteria
1. Subjects who are under physician's advice, treatment, and/or medication for diabetes, renal disease, galactosemia, osteoporosis, thyroid dysfunction, hypertension, dyslipidemia, gastrointestinal diseases.
2. Subjects who use pacemakers and/or defibrillators.
3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, respiratory diseases, and/or affected with infectious diseases requiring reports to the authorities.
4. Subjects with major surgical history relevant to the digestive system.
5. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data.
6. Subjects with severe anemia.
7. Post-menopausal women complaining of obvious physical changes.
8. Subjects who are at risk of having allergic reactions to drugs and/or foods especially based on milk, eggs, wheat, sesame, mackerel, soy beans, apples, etc.
9. Subjects with lactose intolerance, and/or who be unable to drink a cup of milk (200 ml) within 5 minutes.
10. Subjects who regularly take medicine, functional foods, and/or supplements which would affect mineral absorption.
11. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
12. Subjects who donated either 400 ml whole blood within 16 wks, 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to this study.
13. Pregnant or lactating women or women who expect to be pregnant.
14. Subjects who currently participate in other clinical trials, or participated within the last 4 wks prior to this study.
15. Subjects who are ineligible due to physician's judgment.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.ac.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
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060935
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| Registered date | File name |
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| Registered date | File name |
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