UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of changes in blood amino acid levels with consumption of the protein drink
Acronym	A verification study of changes in blood amino acid levels with consumption of the protein drink
Scientific Title	A verification study of changes in blood amino acid levels with consumption of the protein drink: a randomized, placebo-controlled, double-blind, crossover trial
Scientific Title:Acronym	A verification study of changes in blood amino acid levels with consumption of the protein drink
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of kiwi fruit juice powder presence/absence on blood amino acid levels after consumption of the protein drink in healthy Japanese adult subjects. Also, to investigate the effects of consumption of the kiwi fruit juice powder added protein drink on bowel movement in healthy Japanese adult subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The incremental area under the curve (IAUC) of total amino acid amount
Key secondary outcomes	1-1. The measured values of stool frequency, stool volume, stool days, stool shape, stool smell, exhilarating feeling at one and two weeks after the start of test-food consumption 1-2. The amount of changes of stool frequency, stool volume, stool days, stool shape, stool smell, exhilarating feeling between before test-food consumption and one and two weeks after the start of test-food consumption 2. AUC, Cmax, Tmax, and the measured values at each assessment point* of total amino acid amount 3. AUC, Cmax, Tmax, and the measured values at each assessment point* of taurine, phosphoethanolamine, aspartic acid, hydroxyproline, threonine, serine, asparagine, glutamic acid, glutamine, sarcosine, alpha-aminoadipic acid, proline, glycine, alanine, citrulline, alpha-amino-n-butyric acid, valine, cystine, methionine, cystathionine, isoleucine, leucine, tyrosine, beta-alanine, phenylalanine, beta-aminoisobutyric acid, homocysteine, gamma-aminobutyric acid, monoethanolamine, hydroxylysine, ornithine, 1-methylhistidine, histidine, lysine, 3-methylhistidine, tryptophan, anserine, carnosine, arginine, alloisoleucine, Fischer ratio (BCAA/AAA) *Each assessment point indicates before test-food consumption at 30, 45, 60, 90, 120 and 180 minutes after test-food consumption

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	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Duration: Two weeks Test food: Protein processed food 1 Control food: Protein processed food 2 Administration: One pack per day at any time during the day by dissolving it well in approximately 200 mL of water (adequate intake) with a shaker [Period I] 1. Protein processed food 1 2. wash out period 3. Protein processed food 2 [Period II] 1. Protein processed food 2 2. wash out period 3. Protein processed food 1 *The washout period must be at least one week. *If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: same as above Test food: same as above Control food: same as above Administration: same as above [Period I] 1. Protein processed food 2 2. wash out period 3. Protein processed food 1 [Period II] 1. Protein processed food 1 2. wash out period 3. Protein processed food 2 *The washout period must be at least one week. *If you forget to take the test food, take it as soon as you remember within the day.
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	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adult subjects 2. Subjects who have a protein taking habit 3. Subjects who defecate three to five times per week 4. Subjects who are judged as eligible to participate in the study by the physician 5. Subjects who have relatively few stool frequency during a week before screening (before test-food consumption)
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who have abnormal values in plasma amino acids fractionation 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 6. Currently taking medicines (include herbal medicines) and supplements 7. Subjects who regularly use anticoagulants, such as warfarin 8. Subjects whose daily protein intake from protein drink is 25 g or more 9. Subjects who cannot stop the intake of protein drink other than the test food during this trial 10. Subjects who are planning to increase the amount of exercise during this trial 11. Subjects who are allergic to medicines and/or the test food related products, particularly milk, kiwi fruits, and latex 12. Subjects who have lactose intolerance 13. Subjects who are pregnant, breast-feeding, and planning to become pregnant 14. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 15. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	NOF CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	info@takara-clinic.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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 28 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Published

Result
URL related to results and publications	https://www.pieronline.jp/content/article/0386-3603/48090/1571
Number of participants that the trial has enrolled	10
Results	Kamioka Y, Miyazaki A, Takahashi Y, Takara T. Changes in Blood Amino Acid Levels after Consuming a Protein Drink with Kiwi Fruit Juice Powder-Randomized, Placebo-controlled, Double-blind, Crossover Trial-. Jpn Pharmacol Ther. 2020; 48(9): 1571-1587
Results date posted	2021 Year 05 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 09 Month 29 Day
Baseline Characteristics	Refer to the paper
Participant flow	Refer to the paper
Adverse events	Refer to the paper
Outcome measures	Refer to the paper
Plan to share IPD	Undecided
IPD sharing Plan description	To require consultation among related companies

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 01 Month 24 Day
Date of IRB	2020 Year 01 Month 24 Day
Anticipated trial start date	2020 Year 01 Month 30 Day
Last follow-up date	2020 Year 04 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 28 Day
Last modified on	2021 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044801