UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042784 |
|---|---|
| Receipt number | R000048820 |
| Scientific Title | Investigation of the effects of continuous intake of test foods on muscles |
| Date of disclosure of the study information | 2020/12/18 |
| Last modified on | 2021/07/01 11:24:57 |
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Basic information
Public title
Investigation of the effects of continuous intake of test foods on muscles
Acronym
Investigation of the effects of continuous intake of test foods on muscles
Scientific Title
Investigation of the effects of continuous intake of test foods on muscles
Scientific Title:Acronym
Investigation of the effects of continuous intake of test foods on muscles
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of continuous intake of test foods for 12 weeks on muscles in healthy Japanese men and women aged 45 to 65 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition (skeletal muscle mass, basal metabolic rate, protein mass, body fat mass, body weight, BMI, muscle mass, body fat percentage, upper limb muscle mass, trunk muscle mass, leg muscle mass, body water content)
Key secondary outcomes
Special blood test (TNF-alpha, IL-6), Chalder Fatigue Scale, VAS questionnaire, subjective symptom questionnaire, motor ability test (lower limb muscle strength, grip strength, eye-opening one-leg standing test, 6-minute walk test, 6-m walk test, 2 steps test, 10 times chair stand-up test)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test foods consumption for 12 weeks.
Interventions/Control_2
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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Japanese men and women aged 45 to 65 years old at the time of informed consent.
2)Subject who is worried about muscle weakness.
3)Subject who can measure physical fitness.
4)Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing.
5)Subject who can continuously take the test food for 12 weeks during the test period.
6)Subject who is judged not to be sick by the interview with the investigator.
Key exclusion criteria
1)Subject who is currently undergoing medication or outpatient treatment due to some serious illness or knee or low back pain.
2) Heavy drinkers.
3)Subject who has suffered severe damage to the locomotorium such as fractures, tendon ruptures, and pulled muscle in the last year.
4)Subject who has experienced strong chest pain or abnormal pulse at rest.
5)Subject who uses a pacemaker or artificial joints.
6)Subject who frequently has palpitation, shortness of breath, lightheadedness, dizziness or loss of consciousness.
7)Subject diagnosed with leg and waist disorders.
8)Subject who has a history of knee surgery, has a disease, or uses a cane on a daily basis.
9)Subject who has high-intensity exercise habits.
10)Subject who is under exercise therapy or diet therapy.
11)Subject who has an allergy for test food.
12)Subject who has or had a history of either medicine or alcohol dependence syndrome.
13)Subject who has or had a history of mental illness (ex. depression) or sleep disturbance.
14)Subject who has irregular work rhythms such as working at night and shift work.
15)Subject who has extremely irregular lifestyle such as eating and sleeping.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
ochitani@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
non-disclosure
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
Ethics Committees of Yoga Allergy Clinic
Address
4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel
03-5491-4478
jim@medipharma.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
| 2020 | Year | 12 | Month | 18 | 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
10
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
| 2020 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 14 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 21 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 08 | Day |
Other
Other related information
(Exclusion criteria continued)
16)Subject who has an unbalanced diet.
17)Subject who has or had a history of severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases.
18)Subject who uses health foods, supplements, and medicines that affect muscles.
19)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
20)Subject who has blood drawn or blood component more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition.
21)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
22)Subject who can't keep the daily records.
23)Subject who is judged as an inappropriate candidate according to the screening data.
24)Subject who is considered as an inappropriate candidate by the investigator.
Management information
Registered date
| 2020 | Year | 12 | Month | 18 | Day |
Last modified on
| 2021 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048820
