UMIN-CTR Clinical Trial

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

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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, C_max, T_max, and the measured values at each assessment point* of total amino acid amount

3. AUC, C_max, T_max, 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

Study type

Interventional

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

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

NOF CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2020

Year

01

Month

28

Day

URL releasing protocol

Unpublished

Publication of results

Published

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

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 related information

Registered date

2020

Year

01

Month

28

Day

Last modified on

2021

Year

05

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044801