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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000048451 |
Receipt No. | R000055217 |
Scientific Title | Trial of the efficacy of food ingredients on knee flexibility |
Date of disclosure of the study information | 2022/08/03 |
Last modified on | 2022/07/25 |
Basic information | ||
Public title | Trial of the efficacy of food ingredients on knee flexibility in healthy men and women (SWE-2021-04-HBLOCO) | |
Acronym | Trial of the efficacy of food ingredients on knee flexibility | |
Scientific Title | Trial of the efficacy of food ingredients on knee flexibility | |
Scientific Title:Acronym | Trial of the efficacy of food ingredients on knee flexibility | |
Region |
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Condition | ||
Condition | Not applicable | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the effect of food ingredients on knee flexibility |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Knee flexion angle |
Key secondary outcomes |
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 |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Intake of the test foods (12 weeks) | |
Interventions/Control_2 | Intake of the control foods (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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1) Healthy men and women aged 40 to 64 years.
(2) Person with a knee flexion angle of less than 130 degrees. (3) Person who has knee pain. (4) Person who can understand the purpose and content of this study and agree in writing to participate in this study. |
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Key exclusion criteria | (1) Presence of disease in locomotor organs affecting the efficacy assessment of this study.
(2) Person whose keep irregular hours such as shift work. (3) Use of product affecting the data of this study, such as food for specified health use, food with function claims, and medicine. (4) Presence of previous and present serious disease such as cardiac affection, liver disorder, kidney disorder, cardiovascular disorder, lung disorder, diabetes mellitus. (5) Investigator's judgment for other reason. |
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Target sample size | 140 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Suntory Wellness Limited | ||||||
Division name | Institute For Health Care Science | ||||||
Zip code | 619-0284 | ||||||
Address | 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan. | ||||||
TEL | 050-3182-0593 | ||||||
H_Watanabe@suntory.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Suntory Wellness Limited | ||||||
Division name | Institute For Health Care Science | ||||||
Zip code | 619-0284 | ||||||
Address | 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan. | ||||||
TEL | 050-3182-8180 | ||||||
Homepage URL | |||||||
Saori_Omae@suntory.co.jp |
Sponsor | |
Institute | Suntory Wellness Limited |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Medical Station Clinic Research Ethics Committee |
Address | 3-12-8, Takaban, Meguroku, Tokyo |
Tel | 03-6452-2712 |
nakagawa.akiko297@eps.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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
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=R000055217 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |