UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042947 |
|---|---|
| Receipt number | 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 22:56:42 |
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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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048986
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