UMIN-CTR Clinical Trial

Basic information
Public title	Verification of effects of test food intake
Acronym	Verification of effects of test food intake
Scientific Title	Verification of effects of test food intake
Scientific Title:Acronym	Verification of effects of test food intake
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effects of test food for physical function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Motor function, daily activity, body composition, questionnaire evaluation
Key secondary outcomes	Oxidative stress index

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of test food for 12 weeks
Interventions/Control_2	Ingestion of placebo 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	50 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Japanese individuals aged 50-79 years. 2) Individuals who are healthy and are not suffered from a chronic malady. 3) Individuals whose ADL questionnaire scores is higher than 12. 4) Non-smoker 5) Individuals whose BMI scores is not less than 22.5 kg/m2 and less than 30.0 kg/m2. 6) Individulals who can visit an inspection facility and be inspected in designated days. 7) Individuals whose written informed consent has been obtained.
Key exclusion criteria	1) Those who meet the criteria of sarcopenia from the results of grip strength and gait speed (Male subjects whose grip strength values are less than 26.0kg and gait speed is less than 0.8 m/s. Female subjects whose grip strength values are less than 18.0kg and gait speed is less than 0.8m/s.) 2) Individuals who have been hospitalized with joint pains such as knees and lower back within 3 months 3) Individuals who is allergic to test food 4) Individuals with a large history of surgery on the gastrointestinal tract, such as gastrectomy, gastrointestinal suture, and intestinal resection 5) Individuals who have difficulty in participating in the study due to liver disease, kidney disease, heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes, and other diseases 6) Individuals with a history of serious cardiovascular disease 7) Individuals who regularly use amino acid, protein-reinforced foods or beverages for the purpose of maintaining physical fitness, improving motor function or dieting 8) Individuals who regularly use medicines and supplements that may affect this study (However, those who can suspend intake at the time of the test are not applicable) 9) Individuals who have experienced bad mood or poor physical condition due to blood sampling in the past 10) Individuals who donated blood more than 200mL between the month before the start of the test, or who is scheduled to do so during the test period 11) Individuals who participated in other clinical studies in the past 4 weeks. 12) Individuals who drink a lot of alcohol 13) Individuals who have extremely irregular eating habits 14) Irregular shift workers 15) Individuals who do not agree with the purpose of the explanation of this examination 16) Individuals judged inappropriate for the study by the principal.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Akanuma
Organization	Akanuma Surgery Clinic
Division name	Department
Zip code	005-0842
Address	14-1, Isiyama2-jo 6, Minami-ku Sapporo-shi, Hokkaido
TEL	011-200-9431
Email	y-kohzai@kyowa-t.com

Public contact
Name of contact person	1st name Yoshimichi Middle name Last name Kozai
Organization	Kyowa Trial Co., Ltd.
Division name	Clinical Trials Division
Zip code	064-0923
Address	1-40, minami 23-jo nisi 11-tyoume, tyuuou-ku Sapporo-shi, Hokkaido
TEL	011-200-9431
Homepage URL	https://www.kyowa-t.com/
Email	y-kohzai@kyowa-t.com

Sponsor
Institute	Akanuma Surgery Clinic
Institute
Department

Funding Source
Organization	Morinaga & 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	Akanuma surgery clinic ethics review board
Address	14-1, Isiyama2-jo 6, Minami-ku Sapporo-shi, Hokkaido
Tel	011-200-9431
Email	y-kohzai@kyowa-t.com

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	2020 Year 03 Month 31 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	2019 Year 08 Month 20 Day
Date of IRB	2019 Year 08 Month 27 Day
Anticipated trial start date	2019 Year 09 Month 18 Day
Last follow-up date	2019 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 17 Day
Last modified on	2020 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043324