UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049058 |
|---|---|
| Receipt number | R000055895 |
| Scientific Title | Evaluation of the effect of a single intake of protein hydrolysate on mood index and blood index -Placebo-controlled, randomized, double-blind, crossover study- |
| Date of disclosure of the study information | 2022/10/02 |
| Last modified on | 2023/03/31 11:57:30 |
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Basic information
Public title
Evaluation of the effect of a single intake of protein hydrolysate on mood index and blood index
Acronym
Evaluation of the effect of a single intake of protein hydrolysate on mood index and blood index
Scientific Title
Evaluation of the effect of a single intake of protein hydrolysate on mood index and blood index
-Placebo-controlled, randomized, double-blind, crossover study-
Scientific Title:Acronym
Evaluation of the effect of a single intake of protein hydrolysate on mood index and blood index
Region
| Japan |
Condition
Condition
Healthy adult male and female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of a single intake of protein hydrolysate on mood index and blood index
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma acetyl-L-carnitine concentration
Key secondary outcomes
Plasma carnitine concentration, Plasma free fatty acid concentration, POMS2(Short version), Questionnaire for fatigue symptoms
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 five capsules containing protein hydrolysate per dose.
Interventions/Control_2
Take five capsules without protein hydrolysate per dose.
Interventions/Control_3
Take ten capsules containing protein hydrolysate per dose.
Interventions/Control_4
Take ten 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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females from 20 to 60 years of age at the time of obtaining consent to participate in this study.
2) Subjects who can input data into the electronic logbook using a PC, smartphone, etc.
3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
Subjects have a disease that accompanies mental and physical disorders such as chronic fatigue syndrome, etc. Subjects have undergone gastrointestinal surgery (excluding appendicitis). Subjects are currently taking over-the-counter drugs, quasi-drugs, foods for specified health uses, health foods, or supplements. Subjects take food for specified health use intended for effects on the autonomic nervous system, sleep, metabolism, and intestinal environment, food with function claims, healthy food, etc., or who cannot stop taking it during the test period. Subjects drink a lot of alcohol. Subjects have a smoking habit. Subjects with irregular life rhythms. Subjects may change their lifestyle. Subjects have had a life event that affects their mind and body within the past month. Subjects participated in a study involving the use other foods or drugs, or the application of cosmetics or drugs within one month prior to obtaining consent, or who will participate in another study while participating in this study. Subjects consume a large amount of milk, dairy products, or milk-derived protein every day. Subjects have a habit of doing strenuous exercise at least 3-4 times a week. Subjects have experienced poor mood or deterioration of physical condition due to blood collection. Subjects have donated 200 ml or more of whole blood within 3 months before obtaining consent. Subjects are currently undergoing regular hospital visits and treatment for any illness. Subjects have severe diseases in liver, kidney, heart, metabolic system, etc. Subjects have a history of treatment for heart failure, etc. Subjects may exhibit allergy symptoms to milk or soy, or those who have a lactose intolerant constitution. Subjects with current or past drug or food allergies. Subjects are pregnant or breastfeeding, and those 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
72
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
044-210-5844
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
044-210-5844
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
03-6704-5968
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 西東京さくらクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 02 | 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 | 08 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 24 | 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 | 09 | Month | 29 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055895
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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