UMIN-CTR Clinical Trial

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
Email	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
Email	hk.kim@aoni.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038717