UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048770 |
|---|---|
| Receipt number | R000055558 |
| Scientific Title | To evaluate the effect of the test foods ingestion on vigor and performance |
| Date of disclosure of the study information | 2022/08/26 |
| Last modified on | 2024/02/16 10:29:21 |
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Basic information
Public title
To evaluate the effect of the test foods ingestion on vigor and performance
Acronym
To evaluate the effect of the test foods ingestion on vigor and performance
Scientific Title
To evaluate the effect of the test foods ingestion on vigor and performance
Scientific Title:Acronym
To evaluate the effect of the test foods ingestion on vigor and performance
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of single- and continuous-intake of foods on vitality and performance indicators in healthy subjects between the ages of 20 and less than 60 years who experience daily lability loss and fatigue.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indexes to evalute vitality and energy (POMS2 All Items Version, Visual Analog Scale)
Key secondary outcomes
(Secondary outcomes)
Performance-related indices, Daytime sleepiness scale, Objective sleep status, Physical activity level
(Safety evaluation)
Vital signs, physical measurements (weight, BMI),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
Continuous intake of the test foods for 8 weeks.
Interventions/Control_2
Continuous intake of the placebo foods for 8 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese male and female who are between 20 and less than 60 years old at the time of obtaining written consent.
2.POMS2 All Items Version VA T score : <= 50
3.Subject who feels fatigue on a daily basis.
4.Subject who feels slight drowsiness during the day.
5.Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing.
Key exclusion criteria
1.Subject who is considered as chronic fatigue syndrome or idiopathic chronic fatigue by a doctor and has severe malaise.
2.Subject who is taking medication or under medical treatment due to serious illness.
3.Subject who is under exercise therapy or dietetic therapy.
4.Subject who has not taken foods containing active ingredients or do not like to take them.
5.Subject who has a weak stomach or has tendency to get diarrhea by consuming foods containing active ingredients.
6.Subject who has or had a history of either medicine or alcohol dependence syndrome.
7.Subject who is attending a hospital due to mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea syndrome, etc.), or who has a history of mental illness in the past.
8.Subject with irregular life rhythms due to night shifts or shift work.
9.Subject with extremely irregular lifestyle habits such as eating and sleeping.
10.Subject who has an extremely unbalanced diet.
11.Subject who is alcohol drinking habit (more than 60g/day)
12.Excessive smokers (more than 20 cigarettes/day)
13.Subject with BMI <17kg/m2 or >=30kg/m2.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo, 108-0014, Japan
TEL
03-3431-1260
toya@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo, 108-0014, Japan
TEL
03-3431-1260
Homepage URL
toya@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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
NISHI-UMEDA Clinic for Asian Medical Collaboration Clinical Research Institutional Review Board
Address
Maruito Nishi-Umeda Building 3F, 3-3-45 Umeda Kita-ku, Osaka-shi, Osaka, 530-0001, Japan
Tel
06-4797-5660
kanri@ml.amc-clinic.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
| 2022 | 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
80
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
| 2022 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
(Exclusion criteria continued)
14. Subject with serious current or previous illnesses such as brain disease, malignant tumor, immunological disease, diabetes mellitus, liver disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, or other metabolic diseases.
15.Subject with a History of digestive system resection (excluding appendectomy)
16.Subject who cannot refrain from using foods and supplements which may affect vitality and fatigue reduction.
17.Subject who regularly use or are unable to refrain from using food with functional claims that indicate functionality related to liveliness or fatigue.
18.Subject who regularly use or are unable to refrain from using medicines or quasi-drugs that claim to relieve fatigue.
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 collection or donation more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the start of the study.
21.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
22.Subject who has difficulty observing records on various survey forms.
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 doctor in charge.
Management information
Registered date
| 2022 | Year | 08 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055558
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