UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045831 |
|---|---|
| Receipt number | R000052197 |
| Scientific Title | Biokinetics of blood amino acids by ingestion of the test food |
| Date of disclosure of the study information | 2022/10/21 |
| Last modified on | 2022/11/18 16:05:11 |
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Basic information
Public title
Biokinetics of blood amino acids by ingestion of the test food
Acronym
Biokinetics of blood amino acids by ingestion of the test food
Scientific Title
Biokinetics of blood amino acids by ingestion of the test food
Scientific Title:Acronym
Biokinetics of blood amino acids by ingestion of the test food
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the biokinetics of blood amino acids after a single ingestion for the notification of foods with functional claims.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indexes for biokinetics
AUC(0-360min), iAUC(0-360min), Cmax.
(before and 15,30,60,120,360 minutes after ingestion of the test food. [observation period I,II,III and IV])
Key secondary outcomes
*Secondary indexes
Indexes for biokinetics
Tmax, AUC0-inf, T1/2, MRT(Mean Residence Time), Kel(elimination rate constant).
(before and 15,30,60,120,360 minutes after ingestion of the test food.[observation period I, II, III and IV])
*Safety
[1] measurement of body temperature(1)
[2] Blood pressure, pulsation(1)
[3] Hematologic test(2)
[4] Blood biochemical test(2)
[5] Urine analysis(2)
[6] Doctor's questions(1)
[7] Side effects: expression number and expression rate of side effects(expression rate: number of cases/number of cases analyzed)(3)
[8] Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (3)
(1):Screening, observation period I, II, III and IV
(2):Screening
(3):Observation period I, II, III and IV
*Other index
[1] Baseline characteristics(Screening)
[2] Height(Screening)
[3] Weight, body fat percentage, BMI(Screening, observation period I, II, III and IV)
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
[1]Oral ingestion of a test food A (1 time).
[2]Observation.
[3]Washout (14 days)
[4]Oral ingestion of a test food B (1 time).
[5]Observation.
[6]Washout (14 days)
[7]Oral ingestion of a test food C (1 time).
[8]Observation.
[9]Washout (14 days)
[10]Oral ingestion of a test food D (1 time).
[11]Observation.
Interventions/Control_2
[1]Oral ingestion of a test food D (1 time).
[2]Observation.
[3]Washout (14 days)
[4]Oral ingestion of a test food A (1 time).
[5]Observation.
[6]Washout (14 days)
[7]Oral ingestion of a test food B (1 time).
[8]Observation.
[9]Washout (14 days)
[10]Oral ingestion of a test food C (1 time).
[11]Observation.
Interventions/Control_3
[1]Oral ingestion of a test food C (1 time).
[2]Observation.
[3]Washout (14 days)
[4]Oral ingestion of a test food D (1 time).
[5]Observation.
[6]Washout (14 days)
[7]Oral ingestion of a test food A (1 time).
[8]Observation.
[9]Washout (14 days)
[10]Oral ingestion of a test food B (1 time).
[11]Observation.
Interventions/Control_4
[1]Oral ingestion of a test food B (1 time).
[2]Observation.
[3]Washout (14 days)
[4]Oral ingestion of a test food C (1 time).
[5]Observation.
[6]Washout (14 days)
[7]Oral ingestion of a test food D (1 time).
[8]Observation.
[9]Washout (14 days)
[10]Oral ingestion of a test food A (1 time).
[11]Observation.
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
[1]Males aged 20-64 years.
[2]Individuals who are healthy and have no chronic physical disease including skin disorder.
[3]Individuals whose written informed consent has been obtained.
[4]Individuals who can come to the designated venue for this study and be inspected.
[5]Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1]Individuals using medical foods.
[2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3]Individuals who used a drug to treat a disease in the past 1 month.
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[5]Individuals who are a patient or have a history of or endocrine disease.
[6]Individuals whose BMI is less than 18.5kg/m2 and over 30kg/m2.
[7]Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively.
[8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[9]Individuals who experienced unpleasant feeling during blood drawing.
[10]Individuals who are sensitive to the test food.
[11]Individuals who habitually take the foods for specified health uses (FOSHU) or functional food.
[12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[13] Individuals smoke an average of 21 or more cigarettes per day
[14]Individuals who participated in other clinical studies in the past one month.
[15]Individuals judged inappropriate for the study by the principal.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kazumoto |
| Middle name | |
| Last name | Sasaki |
Organization
Medical Corporation Ichigenkai Sasaki Memorial Hospital
Division name
Chief Director
Zip code
359-1144
Address
1-7-25 Nishitokorozawa Tokorozawa-shi Saitama 359-1144, JAPAN
TEL
+81-429-23-7751
soumuka@sasaki-memorial.com
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Uetake |
Organization
CXwellness, Inc.
Division name
Representative Director
Zip code
103-0023
Address
516 Nihonbashinagatani Bldg, 3-1-6 Nihonbashihoncho, Chuo-ku, Tokyo 103-0023, JAPAN
TEL
+81-3-6225-5601
Homepage URL
uetake@cx-wellness.com
Sponsor or person
Institute
CXwellness, Inc.
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Foods, Ltd
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81528382485
i.takahashi@tes-h.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 21 | 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 | 10 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 22 | Day |
Last modified on
| 2022 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052197
