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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042947
Receipt No. R000048986
Scientific Title A study of the effects of a test-food on aged physical functions
Date of disclosure of the study information 2022/01/12
Last modified on 2021/09/14

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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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