UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033576 |
|---|---|
| Receipt number | R000038288 |
| Scientific Title | A trial evaluating the efficacy of test supplement intake on physical performance and knee complaints |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2020/01/30 09:09:09 |
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Basic information
Public title
A trial evaluating the efficacy of test supplement intake on physical performance and knee complaints
Acronym
A trial evaluating the efficacy of test supplement intake on physical performance and knee complaints
Scientific Title
A trial evaluating the efficacy of test supplement intake on physical performance and knee complaints
Scientific Title:Acronym
A trial evaluating the efficacy of test supplement intake on physical performance and knee complaints
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of test supplement intake on physical performance and knee complaints.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
･30s Chair Stand Test
･6 Minute Walk Test
(baseline, 12, 24 weeks)
Key secondary outcomes
･Japanese Knee Osteoarthritis Measure
(baseline, 12, 24 weeks)
･Safety evaluation; Physical examinations, Hematological tests, Blood biochemistry tests, Urinalysis
(baseline, 12, 24 weeks)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 24 weeks
Test supplement: Soft capsule containing 20 mg of paprika oleoresin
Dose: One capsule per day
Administration: Take the capsule with water or warm water after breakfast
Interventions/Control_2
Duration: 24 weeks
Placebo supplement: Placebo soft capsule
Dose: One capsule per day
Administration: Take the capsule with water or warm water after breakfast
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
| 55 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. men and women aged 55-75 years
2. healthy adults without chronic physical disorder
3. mild knee complaints (including pain during walking, sitting on own heels, or climbing stair)
4. agree with providing written informed consent after fully informed of the contents of capsules and about the study methods
5. those who can visit an inspection facility and be inspected in designated days.
6. anyone judged suitable by the physician in charge
Key exclusion criteria
1. the currently use of medication or medical apparatus for any clinical treatment of disease
2. undergoing clinical treatment for knee and lower back pain
3. a history of surgery for knee or lower back (including hyaluronic acid or steroid injection)
4. the use of walking aids
5. have difficulty walking for 6 min
6. have difficulty standing up from a armless chair, and sitting down
7. a history of rheumatoid arthritis
8. a history of a major disease such as mental disorder, sleep disorder, diabetes, hypertension, hyperlipidemia, bronchitis, and asthma
9 the use of medication for clinical treatment of disease (except for headache, menstruation, or cold ) during the last one month
10. a history of a major disease such as liver, kidney, heart, lung, and blood
11. a history of digestive system disease
12. make a blood donation over 200 mL during the last one month, or over 400 mL during the last three months
13. serious anemia
14. body mass index > 30 kg/m2
15. possible allergy or a history of hypersensitivity to the test materials used in this study
16. often intake of health-promoting foods (including foods for specified health uses, health foods, or supplements) which aimed to improve knee complaints during the last 3 months, or planning to intake those foods during the trial period
17. often intake of vegetable juice, satsuma mandarin (including juice), orange (including juice), or supplements containing a high amount of carotenoids during the last three months
18. excessive intake of alcohol(over 60 g per day)
19. planning to change exercise habit or daily habit during this trial
20. pregnant, breast-feeding, or planning to become pregnant
21. anyone who have been enrolled in other clinical trials during the last three months before the agreement to participate in this trial
22. an employee of a health food, functional food, or cosmetic company (including family member)
23. smoker
24. anyone judged unsuitable by the physician in charge
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Ueno-Asagao Clinic
Division name
-
Zip code
110-0015
Address
6F Kairaku Bldg., 2-7-5 Higashi-Ueno, Taito-ku, Tokyo, Japan.
TEL
03-6240-1162
t.ono@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Bldg., 2-7-5 Higashi-Ueno, Taito-ku, Tokyo, Japan.
TEL
03-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
Riken Vitamin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Riken Vitamin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
TES Holdings Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oriental Ueno Detection Center, general incorporated Association Oriental Occupational Health Association Tokyo Branch
Address
1-20-11 Ueno, Taito-ku, Tokyo
Tel
03-5816-0711
info@tes-h.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
うえのあさがおクリニック(東京都)
Ueno-Asagao Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 01 | 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
100
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
| 2018 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 07 | Month | 05 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 31 | Day |
Last modified on
| 2020 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038288
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