UMIN-CTR Clinical Trial

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
Email	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
Email	ryo.uchida.xs6@asv.ajinomoto.com

Sponsor
Institute	SOUKEN Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053431