UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052311 |
|---|---|
| Receipt number | R000059670 |
| Scientific Title | Evaluation of the Improvement Effects of Oligosaccharide Intake on the Concentration of Anti-Aging Compounds in Blood and Feces |
| Date of disclosure of the study information | 2024/09/26 |
| Last modified on | 2024/04/23 18:27:45 |
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Basic information
Public title
Evaluation of the Improvement Effects of Oligosaccharide Intake on the Concentration of Anti-Aging Compounds in Blood and Feces
Acronym
Evaluation of the Improvement Effects of Oligosaccharide Intake on the Concentration of Anti-Aging Compounds in Blood and Feces
Scientific Title
Evaluation of the Improvement Effects of Oligosaccharide Intake on the Concentration of Anti-Aging Compounds in Blood and Feces
Scientific Title:Acronym
Evaluation of the Improvement Effects of Oligosaccharide Intake on the Concentration of Anti-Aging Compounds in Blood and Feces
Region
| Japan |
Condition
Condition
Male adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this clinical trial is to evaluate the improvement effects of a consumption of oligosaccharides for 4 weeks on the concentration of NAD+ related metabolites in blood and Feces.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NAD+-related metabolites in feces.
NAD+-related metabolites in blood.
Key secondary outcomes
Comprehensive analysis of fecal flora, total bacterial count.
Fecal water content.
Organic acid concentration in feces.
Defecation status.
Abdominal symptoms at times other than defecation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test foods for 4 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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Healthy males aged 60 to 75 years.
2. Subjects who defecate every morning.
3. Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who take habitually (not less than 3 times a week) in the Food for Specified Health Uses (FOSHU) or Foods with Function Claims or supplementary food or health foods or yogurts or lactic acid bacteria beverages or fiber-fortified foods, oligosaccharides which might affect the test results.
2. Subjects who have taken the following medications that may affect the study for 1 month prior to the pre-test, and those who cannot limit their use from the pre-test to the time of the 4W test.
2.1 Intestinal preparations
2.2 Antibiotics
2.3 Vitamins, including vitamin B3
3. Subjects who are in the habit of smoking, or have been in the habit of smoking within the past year.
4. Subjects with excessive alcohol intake.
5. Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
6. Subjects with serious or progressive preexisting illnesses or symptoms.
7. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
8. Subjects having some kind of drug and/or food allergy.
9. Subjects who donated blood or component (200 mL) within the last 1 months.
10. Subjects who donated his blood (400 mL) within the last 3 months.
11. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this research.
12. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
| 2024 | Year | 09 | 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
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
| 2023 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059670
