UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049372 |
|---|---|
| Receipt number | R000056134 |
| Scientific Title | Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effect of nicotinamide mononucleotide (NMN) and/or paprika xanthophyll (PX) on endurance performance |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2025/05/13 14:28:43 |
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Basic information
Public title
The study to evaluate the effect of supplements on endurance performance
Acronym
The study to evaluate the effect of supplements on endurance performance
Scientific Title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effect of nicotinamide mononucleotide (NMN) and/or paprika xanthophyll (PX) on endurance performance
Scientific Title:Acronym
The study to evaluate the effect of nicotinamide mononucleotide (NMN) and/or paprika xanthophyll (PX) on endurance performance
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of NMN and/or PX oral administration on endurance performance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate endurance performance by lactate curve test and heart rate
Key secondary outcomes
1) To evaluate NAD+ in blood
2) To evaluate the metabolites in urine and saliva
3) To evaluate body composition
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
No need to know
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects receive 500 mg/day of NMN and 9 mg/day of PX for 8 weeks
Interventions/Control_2
Subjects receive 500 mg/day of NMN and placebo of PX for 8 weeks
Interventions/Control_3
Subjects receive 9 mg/day of PX and placebo of NMN for 8 weeks
Interventions/Control_4
Subjects receive placebo of NMN and placebo of PX for 8 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1) Subjects who agree to the study
2) Healthy adult males between the ages of 18 and 40
Key exclusion criteria
1) Subjects who are unable to refrain from taking health foods, including dietary supplements, and quasi-drugs, over-the-counter drugs during the study. However, subjects who are prescribed pharmaceuticals or other drugs by a physician or pharmacist for therapeutic purposes should ask them for a decision to discontinue. If use is unavoidable, it must be done with the agreement of the research institution.
2) Subjects who habitually consume NMN-containing or PX-containing products.
3) Subjects who are unable to abstain from smoking during the study.
4) Subjects whose BMI are 30.0 kg/m^2 or more.
5) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion.
6) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required.
7) Subjects who may develop allergic symptoms to research foods, or who may develop serious allergic symptoms to other foods or medicines.
8) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies.
9) Subjects who may change their lifestyle during the study (e.g., long-term travel).
10) Subjects who are judged as unsuitable for the study by their family physician.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kawabata |
Organization
EZAKI GLICO Co., Ltd.
Division name
R&D LABORATORY
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, 555-8502, Japan
TEL
+81-6-6477-8793
hiroshi.kawabata@glico.com
Public contact
Name of contact person
| 1st name | Hironaga |
| Middle name | |
| Last name | Ito |
Organization
EUPHORIA Co., Ltd.
Division name
SPORTS DATA MANAGEMENT DIV.
Zip code
102-0085
Address
Iida Bldg. 2nd Floor, 5-5, Rokubancho, Chiyoda-ku, Tokyo, 102-0085, Japan
TEL
+81-50-1742-8657
Homepage URL
rinsho_glico@eu-phoria.jp
Sponsor or person
Institute
EZAKI GLICO 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
EUPHORIA Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Glico Group
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, 555-8502, Japan
Tel
+81-6-6477-8793
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
| 2024 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
260
Results
Trouble occurred at the analytical laboratory regarding the analysis of biological samples. This made it difficult to continue the test, and the test was terminated.
Results date posted
| 2025 | Year | 05 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male college student on the track and field team
Participant flow
Number of consenting recipients: 260
Number of study break points: 202
Adverse events
None
Outcome measures
None
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | 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 | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056134
