UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049219 |
|---|---|
| Receipt number | R000056057 |
| Scientific Title | Effects of functional food composition X and aerobic exercise on the risk for lifestyle disease |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2022/10/14 14:09:10 |
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Basic information
Public title
Effects of functional food composition X and aerobic exercise on the risk for lifestyle disease
Acronym
Effects of functional food composition X and aerobic exercise on the risk for lifestyle disease
Scientific Title
Effects of functional food composition X and aerobic exercise on the risk for lifestyle disease
Scientific Title:Acronym
Effects of functional food composition X and aerobic exercise on the risk for lifestyle disease
Region
| Japan |
Condition
Condition
NO
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the combined effect of aerobic exercise with functional foods composition on arterial stiffness and related lifestyle disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardiovascular indices
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
4
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Ingestion of functional food and aerobic exercise
*Aerobic exercise training: 45-60min./day,
2 days/Weeks.
*Intervention period: 12-week
Interventions/Control_2
Ingestion of placebo food and aerobic exercise
*Aerobic exercise training: 45-60min./day,
2 days/Weeks.
*Intervention period: 12-week
Interventions/Control_3
Ingestion of functional food (non-exercise)
*Intervention period: 12-week
Interventions/Control_4
Ingestion of placebo food (non-exercise)
*Intervention period: 12-week
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
Japanese women
Key exclusion criteria
1)Individuals who are restricted exercise by their doctors
2)Individuals who have anamnesis of cardiovascular disease
3)Individuals who are using hypertension or hormone medications
4)Smoker
5)Individuals who have allergic reaction to plant
6)Individuals who have a habit of daily vigorous exercises
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Hayashi |
Organization
Kokugakuin University
Division name
Institute of Health and Physical Education, Department of Human Development
Zip code
225-0003
Address
3-22-1 Shin-Ishikawa, Aoba-ku, Yokohama, Kanagawa 225-0003, Japan
TEL
045-910-3732
k-hayashi@kokugakuin.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Hayashi |
Organization
Kokugakuin University
Division name
Institute of Health and Physical Education, Department of Human Development
Zip code
225-0003
Address
3-22-1 Shin-Ishikawa, Aoba-ku, Yokohama, Kanagawa 225-0003, Japan
TEL
045-910-3732
Homepage URL
k-hayashi@kokugakuin.ac.jp
Sponsor or person
Institute
Kokugakuin University
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Border of Kokugakuin University
Address
4-10-28 Higashi, Shibuya-ku, Tokyo 150-8440, Japan
Tel
03-5466-6745
https://www.kokugakuin.ac.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
國學院大學 横浜たまプラーザキャンパス（神奈川県）(Yokohama Tama Plaza Campus of Kokugakuin University (Kanagawa Prefecture))
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 14 | Day |
Last modified on
| 2022 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056057
