UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056794 |
|---|---|
| Receipt number | R000064785 |
| Scientific Title | A parallel-group comparative study on "everyday fatigue" in PapriX |
| Date of disclosure of the study information | 2025/01/27 |
| Last modified on | 2025/12/02 11:48:25 |
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Basic information
Public title
A parallel-group comparative study on "everyday fatigue" in PapriX
Acronym
A parallel-group comparative study on "everyday fatigue" in PapriX
Scientific Title
A parallel-group comparative study on "everyday fatigue" in PapriX
Scientific Title:Acronym
A parallel-group comparative study on "everyday fatigue" in PapriX
Region
| Japan |
Condition
Condition
Healthy adult men and women
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the effect of taking PapriX on "everyday fatigue"
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS Survey
Key secondary outcomes
Ramp stress test, oxygen intake, heart rate, blood pressure, blood oxygen saturation, Skin moisture content, Transepidermal water loss, elasticity, facial image diagnosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take one soft capsule containing paprika xanthophyll (9mg/day) for 8 weeks
Interventions/Control_2
Take one placebo soft capsule 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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women between the ages of 30 and 59
Key exclusion criteria
Those currently undergoing drug treatment for any illness
Those undergoing hormone replacement therapy
Those who have undergone or are undergoing cosmetic medical treatment that affects the face within the past 5 years
Those who cannot refrain from special care that is not performed daily during the study period
Those who cannot refrain from taking beauty supplements or drinks during the study period
Those with a history of food allergies
Those taking medicines (whose efficacy and effect is to recover from fatigue or provide nutrition during physical fatigue) that may affect the study
Those who cannot stop taking health foods (including foods for specified health uses and foods with functional claims) or designated quasi-drugs that may affect the study
Those who are aware of lower back pain, joint pain, lumbar hernia, lower limb disease, palpitations, or anemia
Pregnant or breastfeeding people
Those who may significantly change their lifestyle during the study period (long-term travel, etc.)
Those participating in studies that involve the intake of other foods or drugs
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Funahashi |
Organization
Glico Nutrition Co., Ltd.
Division name
R&D Center
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-Ku, Osaka, 555-8502, Japan
TEL
050-1744-4293
eri.funahashi@glico.com
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hosogi |
Organization
Glico Nutrition Co., Ltd.
Division name
R&D Center
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-Ku, Osaka, 555-8502, Japan
TEL
050-1744-4293
Homepage URL
yumi.hosogi@glico.com
Sponsor or person
Institute
Glico Nutrition Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Glico Group Ethics Committee
Address
4-6-5, Utajima, Nishiyodogawa-Ku, Osaka, 555-8502, Japan
Tel
05017454027
toshihiko.koike@glico.com
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
| 2025 | Year | 01 | Month | 27 | 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
23
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064785
