UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049730 |
|---|---|
| Receipt number | R000056643 |
| Scientific Title | Evaluation of the effect of a single intake of protein hydrolysate on stress-related index -Placebo-controlled, randomized, double-blind, crossover study- |
| Date of disclosure of the study information | 2022/12/13 |
| Last modified on | 2023/06/09 09:14:25 |
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Basic information
Public title
Evaluation of the effect of a single intake of protein hydrolysate on stress-related index
Acronym
Evaluation of the effect of a single intake of protein hydrolysate on stress-related index
Scientific Title
Evaluation of the effect of a single intake of protein hydrolysate on stress-related index
-Placebo-controlled, randomized, double-blind, crossover study-
Scientific Title:Acronym
Evaluation of the effect of a single intake of protein hydrolysate on stress-related index
-Placebo-controlled, randomized, double-blind, crossover study-
Region
| Japan |
Condition
Condition
Healthy adult male and female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of the effect of a single intake of protein hydrolysate on stress-related index
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS 2 short version (Japanese translation)
Key secondary outcomes
Uchida-Kraepelin test (correct answer rate)
Assessment test of cognitive function
Questionnaire for fatigue symptoms
Salivary stress markers
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take three capsules containing protein hydrolysate per dose.
Interventions/Control_2
Take three capsules without protein hydrolysate per dose.
Interventions/Control_3
Take five capsules containing protein hydrolysate per dose.
Interventions/Control_4
Take five capsules without protein hydrolysate per dose.
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females from 20 to 50 years of age at the time of obtaining consent to participate in this study.
2)Participants who can input data into the logbook using electronic tools such as a PC, or smarthone.
3)Participants can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
Participants have a disease that mental and physical disorders. Participants have been diagnosed with a cognitive processing disorder. Participants have undergone gastrointestinal surgery (excluding appendicitis). Participants are currently taking over-the-counter drugs, foods for specified health uses, supplements, etc, or who cannot stop taking supplements during the study period. Participants take food for specified health use, energy drinks, etc, that aim to have effects on the autonomic nervous system, etc. Participants drink a lot of alcohol. Participants have a smoking habit (Participants less than one year after quitting smoking). Participants with irregular life rhythms (shift work, etc.). Participants may change their lifestyle during the examination period. Participants have a life event that affects their mind and body within the past month. Participants participated in a study involving the use of other foods or drugs, or the application of cosmetics or drugs within one month before obtaining consent, or who will participate in another study while participating in this study. Participants consume a large amount of dairy products, etc, every day. Participants have a habit of doing strenuous exercise at least 3-4 times a week. Participants have experienced poor mood or deterioration of physical condition due to blood collection. Participants are currently undergoing regular hospital visits and treatment for any illness. Participants have severe diseases in the liver, heart, metabolic system, etc. Participants have a history of treatment for heart failure, etc. Participants may exhibit allergy symptoms to milk or soy, or have a lactose intolerant constitution. Participants with current or past drug or food allergies. Participants are currently pregnant or breastfeeding, and who wish to become pregnant during the study period. Others subjects are judged to be inappropriate as research subjects by the principal investigator.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Suzuki |
Organization
Ajinomoto Co., Inc.
Division name
Functional Ingredients Development Group, Wellness Value Creation Center, Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
0442105844
katsuya.suzuki.4w9@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Uchida |
Organization
Ajinomoto Co., Inc.
Division name
Functional Ingredients Development Group, Wellness Value Creation Center, Institute of Food Sciences
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
0442105844
Homepage URL
ryo.uchida.xs6@asv.ajinomoto.com
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
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
Suda Clinic institutional review board
Address
2-8-14 takadanobaba, sinjuku-ku, Tokyo
Tel
0367045968
n-yuzawa@imeqrd.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
医療法人社団 浩央会 東小金井さくらクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 13 | 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
| 2022 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 21 | 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 | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056643
