UMIN-CTR Clinical Trial

Basic information
Public title	A study of the effects of a test-food on aged physical functions
Acronym	Effects of a test-food on aged physical functions
Scientific Title	A study of the effects of a test-food on aged physical functions
Scientific Title:Acronym	Effects of a test-food on aged physical functions
Region	Japan

Condition
Condition	Elderly male/female subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm some kind of improvement effect by test-food intakes for 12 weeks, on aged physical functions
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Short physical performance battery
Key secondary outcomes	1. Grip strength 2. Leg muscle strength 3. Walking test for 6 min 4. Soft lean mass 5. Body fat mass 6. Muscle mass balance (right/left arm, body trunk, right/left leg) 7. Short version of POMS2 8. Changes in clinical test values

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test food-1 with water/lukewarm (200 mL) to the subjects, 2 packages a day for 12 weeks.
Interventions/Control_2	Oral ingestion of the test food-2 with water/lukewarm (200 mL) to the subjects, 2 packages a day for 12 weeks.
Interventions/Control_3	Oral ingestion of the placebo food with water/lukewarm (200 mL) to the subjects, 2 packages a day for 12 weeks.
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) Male/female subjects 65 and above at consent. (2) Subjects who have no difficulty in carrying out the designated exercise twice a week. (3) Subjects who can give consent forms to join this test after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) Subjects who will take steadily in the medicines (muscle-enhancing/anti-inflammation (over twice a week)/growth hormone/anti-dementia/anti-choline/sleeping pill/anti-fear/anti-depression/anti-mental disease/SGLT2-inhibitory/anti-Shenkui), which might affect the test results. (2) Subjects who have a habit of exercises, except taking a walk. (3) Subjects who have any difficulty in refraining from taking steadily (over once a week) in the health-specific/functional/supplementary/health foods, including amino acids and/or proteins, which might reveal some kind of effect for maintaining their muscle and muscular strength, and inhibiting a failure of those. (4) Subjects who are given a massage/chiropractic steadily (over once a week) and/or will be given those, which might affect the test results during test period. (5) Subjects with previous/present medical history of serious diseases in heart, liver, kidney and/or digestive organs. (6) Subjects who excessively take alcohol. (7) Subjects with extremely irregular eating habits and life rhythms, midnight work and/or irregular shift one. (8) Subjects with wheat allergy. (9) Subjects who are now under the other clinical test with a medicine/food, or took part in that within 4 weeks before this test, or will join that after giving informed consent to join this test. (10) Subjects who donated over 200 mL of their whole blood and/or blood components within a month before this test. (11) Males who donated over 400 mL of their whole blood within the last 3 months before this test. (12) Females who donated over 400 mL of their whole blood within the last 4 months before this test. (13) Males who will be collected over 1200 mL in total of their blood within 12 months, before and in this test. (14) Females who will be collected over 800 mL in total of their blood within 12 months, before and in this test. (15) Others who have been determined as ineligible for entry, according to the principal/sub investigator's opinions.
Target sample size	21

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Division of Clinical Research
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Clinical Planning Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Nisshin Seifun Group Inc.
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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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 01 Month 12 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	2020 Year 11 Month 21 Day
Date of IRB	2020 Year 11 Month 20 Day
Anticipated trial start date	2021 Year 01 Month 12 Day
Last follow-up date	2021 Year 04 Month 28 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 01 Month 08 Day
Last modified on	2021 Year 09 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048986

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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