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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Elderly male/female subjects | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 21 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |