UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060307 |
|---|---|
| Receipt number | R000068860 |
| Scientific Title | Effects of intake of capsules containing sialylglycopeptide on blood D-amino acid concentration in humans -open study- |
| Date of disclosure of the study information | 2026/01/09 |
| Last modified on | 2025/12/25 17:05:29 |
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Basic information
Public title
Effects of intake of capsules containing sialylglycopeptide on blood D-amino acid concentration in humans -open study-
Acronym
Effects of intake of capsules containing sialylglycopeptide on blood D-amino acid concentration in humans -open study-
Scientific Title
Effects of intake of capsules containing sialylglycopeptide on blood D-amino acid concentration in humans -open study-
Scientific Title:Acronym
Effects of intake of capsules containing sialylglycopeptide on blood D-amino acid concentration in humans -open study-
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of intake of capsules containing milk-derived sialylglycopeptide on blood D-amino acid concentration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood D-serine and D-alanine concentration
Key secondary outcomes
Blood L-serine and L-alanine concentration, D/L-serine ratio, and D/L-alanine ratio
Urine L-serine and L-alanine concentration, D/L-serine ratio, D/L-alanine ratio, D-serine/creatinine ratio, and D-alanine/creatinine ratio
Fecal L-serine and L-alanine concentration, D/L-serine ratio, and D/L-alanine ratio
Intestinal bacterial count by real-time PCR
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 4 weeks (once a day, 6 capsules)
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged 20-64 years
2) Those who received a sufficient explanation of the study's objectives and procedures, fully understood the information, voluntarily agreed to participate, and were able to personally sign a written informed consent form
Key exclusion criteria
1) Persons with a medical history of or receiving medical treatment for the following diseases: diabetes, or renal, hepatic, cardiovascular, thyroid, adrenal, or metabolic diseases
2) Persons regularly taking medicines for chronic diseases
3) Persons regularly consuming foods containing lactic acid bacteria, bifidobacterium, oligosaccharide, live microbes, or fermented food
4) Persons taking supplements, consuming a diet, or taking medicines that affect fatigue or sleep
5) Persons working day-night shifts, irregular shifts, or those working night shifts twice during the study period
6) Persons with irregular holidays
7) Persons engaging in manual labor such as heavy cargo transport
8) Persons smoking 21 or more cigarettes a day
9) Persons regularly consuming high-caffeine drinks (equivalent to seven or more cups of coffee a day)
10) Persons with allergic symptoms to certain foods
11) Persons with substance dependence, alcohol use disorder, or those with a medical history of these disorders
12) Persons who are pregnant or lactating, or intending to become pregnant during the study period
13) Persons who have donated more than 200 ml of blood within 1 month, more than 400 ml within 3 months, or plasma or platelet within 2 weeks prior to providing informed consent section for this study
14) Persons who took part in another clinical study within 3 months prior to the start of the present study or who are currently taking part in or intending to take part in another clinical study during the study period
15) Persons deemed unsuitable by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Watanabe |
Organization
Megmilk Snow Brand Co., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2, Minamidai, Kawagoe-shi, Saitama
TEL
049-242-8111
masayuki-watanabe@meg-snow.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sugino |
Organization
Soiken Inc.
Division name
R&D Division
Zip code
560-0082
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka-shi, Osaka
TEL
06-6871-8888
Homepage URL
sugino@soiken.com
Sponsor or person
Institute
Megmilk Snow Brand 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
IRB of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa, Osaka-shi, Osaka
Tel
06-6398-0203
fukudaclinicIRB@gmail.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
| 2026 | Year | 01 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2026 | Year | 01 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068860
