UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039587 |
|---|---|
| Receipt number | R000045107 |
| Scientific Title | Effect test of continuous intake of test food for 8 weeks on endurance and fatigue in healthy adult women |
| Date of disclosure of the study information | 2020/03/05 |
| Last modified on | 2020/07/30 09:19:25 |
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Basic information
Public title
Effect test of continuous intake of test food for 8 weeks on endurance and fatigue in healthy adult women
Acronym
Effect test of continuous intake of test food for 8 weeks on endurance and fatigue in healthy adult women
Scientific Title
Effect test of continuous intake of test food for 8 weeks on endurance and fatigue in healthy adult women
Scientific Title:Acronym
Effect test of continuous intake of test food for 8 weeks on endurance and fatigue in healthy adult women
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 examine the effects on endurance and fatigue of Japanese women aged between 40 and 70 years old by taking test foods continuously for 8 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Primary efficacy assessment
VAS questionnaire
Key secondary outcomes
2)Secondary evaluation of effectiveness
POMS2 shortened version,body composition,shuttle stamina walk test
3)Safety evaluation
Vital signs,biochemical tests, hematological tests,adverse events
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
8-week intake of the test food
Interventions/Control_2
8-week intake of the placebo food
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1.Healthy Japanese female aged 40 years or older and younger than 70 years at the time of the informed consent.
2.Subject who feels tired on a daily basis.
3.Subject who usually takes three meals a day.
4.Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria
1.Heavy drinker
2.Subject who has strong exercise habits.
3.Subject who has experienced chest pain or abnormal pulse at rest.
4.Subject who frequently has palpitations, shortness of breath, lightheadedness, dizziness or loss of consciousness.
5.A family member who has died suddenly for unknown reasons.
6.Subject who has been diagnosed as having problems with the legs.
7.Subject who is receiving the rheumatism treatment.
8.Subject with a history of knee surgery or disease, or who regularly use of cane.
9.Subject with severe hay fever symptoms affecting fatigue.
10.Subject whose protein intake is restricted by a doctor (including mild restrictions).
11.Subject who is taking medication or under medical treatment because of some serious disease.
12.Subject who is under exercise therapy or dietetic therapy.
13.Subject who has an allergy for test food(27 items: milk, soy).
14.Subject who has or had a history of either medicine or alcohol dependence syndrome.
15.Subject who has or had a history of mental illness (depression) or sleep disturbance.
Target sample size
30
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
CHARLE CO.,LTD.
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 Nihonbashi Egawa Clinic
Address
2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel
03-5204-0311
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 | 03 | Month | 05 | 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
| 2020 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 07 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 21 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 27 | Day |
Other
Other related information
(Exclusion criteria continued)
16.Subject who has irregular work rhythms such as working at night and shift work.
17.Subject who has extremely irregular lifestyle such as eating and sleeping.
18.Subject who has an unbalanced diet.
19.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.
20.Subject who uses health foods, supplements, and pharmaceuticals that affect protein metabolism (including protein) or reduce fatigue.
21.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.
22.Subject who has blood drawn or blood component more than 200mL within the past 1 months or more than 400mL within the past 3 months from the day of the consent acquisition.
23.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
24.Subject who can't keep the daily records.
25.Subject who is judged as an inappropriate candidate according to the screening data.
26.Subject who is considered as an inappropriate candidate by the doctor in charge.
Management information
Registered date
| 2020 | Year | 02 | Month | 25 | Day |
Last modified on
| 2020 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045107
