UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048758 |
|---|---|
| Receipt number | R000055479 |
| Scientific Title | Effects of Combination of Consuming the Test Food and Mild Exercise on Physical Performance (Mobility Function) in Healthy Middle-Aged and Older Adults. |
| Date of disclosure of the study information | 2023/08/26 |
| Last modified on | 2024/03/18 14:48:10 |
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Basic information
Public title
Effects of Combination of Consuming the Test Food and Mild Exercise on Physical Performance (Mobility Function) in Healthy Middle-Aged and Older Adults.
Acronym
Effects of Combination of Consuming the Test Food and Mild Exercise on Physical Performance (Mobility Function) in Healthy Middle-Aged and Older Adults.
Scientific Title
Effects of Combination of Consuming the Test Food and Mild Exercise on Physical Performance (Mobility Function) in Healthy Middle-Aged and Older Adults.
Scientific Title:Acronym
Effects of Combination of Consuming the Test Food and Mild Exercise on Physical Performance (Mobility Function) in Healthy Middle-Aged and Older Adults.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effects of combination of consuming the test food and mild exercise on physical performance (mobility function) in healthy middle-aged and older a
dults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor function related indexes.
･Knee extension muscular strength measurement.
･Five times sit to stand test
(Screening, Week 0, Week 4, Week8, Week 12).
Key secondary outcomes
*Secondary indexes
QOL related index.
･SF-36v2 Japanese version (Acute version)(1).
*Safety
[1] Hematologic test (2)
[2] Blood biochemical test (2)
[3] Urine analysis (2)
[4] Blood pressure, pulsation (1)
[5] Weight, body fat percentage, BMI(1)
[6] Doctor's questions/ Adverse events (1)
[7] Subject's diary (3)
*Other indexes
[1] Baseline characteristics(4)
[2] Height measurement(4)
[3] Electrocardiogram (4)
(1): Screening, Week 0, Week 4, Week8, Week 12
(2): Screening, Week 0, Week8, Week 12
(3):From the first day of ingestion of a test material to the last day of the test
(4): Screening
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
| Food |
Interventions/Control_1
Oral intake of the test product (1 packet (3 g), 3 times a day: 12 weeks) and exercise (Once every 2 days: 12 weeks).
Interventions/Control_2
Oral intake of the placebo product (1 packet (3 g), 3 times a day: 12 weeks)and exercise (Once every 2 days: 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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1] Healthy Japanese males aged 50-64 years.
[2] Individuals who are healthy and have no chronic physical disease.
[3] Individuals who do not have a habit of exercising regularly and feel the motor functional decline.
[4] Individuals whose written informed consent has been obtained after explanation of this study.
[5] Individuals who can have an examination on a designated check day.
[6] Individuals who are judged appropriate for the study by the principal.
Key exclusion criteria
[1] Individuals who may develop allergic symptoms to yams
[2] Individuals who have difficulty in performing the designated exercise at home during the test period.
[3] Individuals using medical products.
[4] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[5] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[6] Individuals who contract or have a history of serious endocrine disease.
[7] Individuals with a history or current medical history of cardiac disease, or with abnormalities in electrocardiogram tests.
[8] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[9] Individuals who are sensitive to foods, and medical products.
[10] Individuals whose BMI is over 30 kg/m2.
[11] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[12] Individuals who have a habit of continuous intake of functional foods, health foods, supplements, and beverages (excepting individuals who can suspend intake for a period of time at obtaining informed consent.), and who plan to consume such foods during the test period.
[13] Individuals who are salespeople or often work outside the office with exercise habits.
[14] Individuals who are alcoholism or excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[15] Individuals who are likely to undergo a significant change in lifestyle, such as long-term business trips or travel during the research period.
[16] Individuals who are or are possibly, or are lactating.
[17] Individuals who participated in other clinical studies in the past 3 months.
[18] Individuals who are or whose family is engaged in health foods of functional foods.
[19] Individuals judged inappropriate for the study by the principal.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinc
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 Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
i.takahashi@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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 26 | 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
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 10 | 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 | 08 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055479
