UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033941 |
|---|---|
| Receipt number | R000038717 |
| Scientific Title | The effect of Alaska pollack protein supplementation at breakfast for 12 weeks beyond habitual intakes on lean body mass and bone mineral density. |
| Date of disclosure of the study information | 2018/08/30 |
| Last modified on | 2021/12/09 17:13:59 |
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Basic information
Public title
The effect of Alaska pollack protein supplementation at breakfast for 12 weeks beyond habitual intakes on lean body mass and bone mineral density.
Acronym
The effect of Alaska pollack protein supplementation at breakfast for 12 weeks beyond habitual intakes on lean body mass and bone mineral density.
Scientific Title
The effect of Alaska pollack protein supplementation at breakfast for 12 weeks beyond habitual intakes on lean body mass and bone mineral density.
Scientific Title:Acronym
The effect of Alaska pollack protein supplementation at breakfast for 12 weeks beyond habitual intakes on lean body mass and bone mineral density.
Region
| Japan |
Condition
Condition
sarcopenia, osteoporosis
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to determine the effect of Alaska pollack protein supplementation at breakfast for 12 weeks beyond habitual intakes on lean body mass and bone mineral density in older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following measures would be conducted before and after 12 weeks of intervention.
1) Lean body mass and bone mineral density
Key secondary outcomes
1) Physical functional parameter
2) physical activity(accelerometer)
3) morningness-eveningness type, pittsburgh sleep quality index, food frequency questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Breakfast (0600 - 1000): intake of Alaska pollack protein 4.5 g/day for 12 weeks
Interventions/Control_2
Breakfast (0600 - 1000): intake of milk protein 4.5 g/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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Above 65 years old people requiring support
2) Gives informed consent, agrees to be randomly assigned
Key exclusion criteria
1) The principal investigator or the principal doctor judge the subject as inappropriate
2) Alaska pollack protein allergy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shigenobu |
| Middle name | |
| Last name | Shibata |
Organization
Waseda University
Division name
Faculty of Science and Engineering
Zip code
162-8480
Address
2-2 Wakamatsu, Shinjuku, Tokyo
TEL
03-5369-7318
shibatas@waseda.jp
Public contact
Name of contact person
| 1st name | Hyeon-Ki |
| Middle name | |
| Last name | Kim |
Organization
Waseda University
Division name
School of Advanced Science and Engineering
Zip code
162-8480
Address
2-2 Wakamatsu, Shinjuku, Tokyo
TEL
03-5369-7318
Homepage URL
hk.kim@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Nippon Suisan Kaisha, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nippon Suisan Kaisha, Ltd. HUMAN LINK Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
1-104 Totsuka, Shinjuku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2018 | Year | 08 | Month | 30 | 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
65
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
| 2018 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2018 | Year | 08 | Month | 29 | Day |
Last modified on
| 2021 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038717
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
