UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033576
Receipt No. 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 2019/08/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email r.shimizu@tes-h.co.jp

Sponsor
Institute Riken Vitamin Co., Ltd.
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038288

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.