UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046829 |
|---|---|
| Receipt number | R000053431 |
| Scientific Title | Evaluation of the effect of a single intake of protein hydrolysate on blood metabolic indices in humans -Placebo-controlled, randomized, double-blind, crossover study- |
| Date of disclosure of the study information | 2022/02/06 |
| Last modified on | 2022/07/15 11:23:06 |
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Basic information
Public title
Evaluation of the effect of a single intake of protein hydrolysate on metabolic indices in blood
Acronym
Evaluation of the effect of a single intake of protein hydrolysate on metabolic indices in blood
Scientific Title
Evaluation of the effect of a single intake of protein hydrolysate on blood metabolic indices in humans
-Placebo-controlled, randomized, double-blind, crossover study-
Scientific Title:Acronym
Evaluation of the effect of a single intake of protein hydrolysate on blood metabolic indices in humans
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 metabolic indices in blood
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma metabolism-related biomarkers
Key secondary outcomes
Fatigue-related questionnaire
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 1 capsule containing protein hydrolysate per dose.
Interventions/Control_2
Take 1 capsule without protein hydrolysate per dose.
Interventions/Control_3
Take 5 capsule containing protein hydrolysate per dose.
Interventions/Control_4
Take 5 capsule 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 feel daily fatigue.
3) Subjects who can input data into the electronic logbook using a PC, smartphone, etc.
4) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1) Subjects who have been diagnosed with or are undergoing treatment for mood disorders such as depression
2) Subjects who regularly use health foods such as supplements that claim to have effects on stress and mental health.
3) Subjects who consume a large amount of milk, dairy products, or milk-derived protein every day.
4) Subjects who have a habit of doing strenuous exercise.
5) Subjects who have an irregular life cycle
6) Subjects who may change their lifestyle such as a long trip, etc.
7) Subjects with gastrointestinal weakness, history of gastrointestinal problems, or current illness.
8) Subjects who drink a lot of alcohol.
9) Subjects who have a smoking habit.
10) Subjects who participated in a study involving the use other foods or medicines, or the application of cosmetics or medicines within one month prior to obtaining consent, or who will participate in another study while participating in this study.
11) Subjects who have donated 200 mL or more of blood (including whole blood and components) for 4 months before the start of the study.
12) Subjects who have experienced bad feeling or poor in physical condition due to blood collection in the past.
13) Subjects who may exhibit symptoms of allergy to milk or soy, or those who have a lactose intolerant constitution.
14) Subjects who are pregnant, or breast-feeding, or who planning to be pregnant during the study period.
15) Subjects with a history of serious hepatic, renal, or cardiac disease.
16) Subjects with a history or current illness of hepatitis, or severe anemia.
17) Subjects who are currently undergoing regular hospital visits and treatment for any kind of illness.
18) Subjects who are judged as unsuitable for the study because of the menstrual disorders or etc. by the investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Murakami |
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
hitoshi.murakami.vf4@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
SOUKEN 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Building, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1555
jimukyoku@mail.souken-r.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
芝パレスクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 06 | 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
| 2021 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 13 | 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 | 02 | Month | 04 | Day |
Last modified on
| 2022 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053431
