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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039280
Receipt No. R000044801
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
Date of disclosure of the study information 2020/01/28
Last modified on 2020/12/25

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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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 10
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
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
2020 Year 12 Month 25 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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