UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047412 |
|---|---|
| Receipt number | R000053987 |
| Scientific Title | A Study of effect of a Single Ingestion of the Test Food on Autonomic Properties. |
| Date of disclosure of the study information | 2023/04/06 |
| Last modified on | 2022/11/04 15:50:16 |
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Basic information
Public title
A Study of effect of a Single Ingestion of the Test Food on Autonomic Properties.
Acronym
A Study of effect of a Single Ingestion of the Test Food on Autonomic Properties.
Scientific Title
A Study of effect of a Single Ingestion of the Test Food on Autonomic Properties.
Scientific Title:Acronym
A Study of effect of a Single Ingestion of the Test Food on Autonomic Properties.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effect of a single ingestion of the test food on autonomic properties.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate measurements with my Beat.
(Screening,Observation Period I,Observation Period II,Observation Period III,Observation Period IV.)
Key secondary outcomes
*Secondary indexes
[1] Mental questionnaire (1)
[2] Taste questionnaire (1)
*Safety indexes
[1] Blood pressure, pulsation(1)
[2] Weight, body fat percentage, BMI(1)
[3] Doctor's questions(1)
[4] Subject's diary(2)
*Other indexes
[1] Baseline characteristics(3)
(1):Screening,Observation Period I,Observation Period II,Observation Period III,Observation Period IV.
(2):Everyday from the day before the Observation Period I to the day before the Observation Period IV.
(3):Screening
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
[1] Oral ingestion of a placebo food (1 time/200ml).
[2] Observation.
[3] Washout (over 2days)
[4] Oral ingestion of a test food B (1 time/200ml).
[5] Observation.
[6] Washout (over 2days)
[7] Oral ingestion of a test food A (1 time/200ml).
[8] Observation.
[9] Washout (over 2days)
[10] Oral ingestion of a placebo food (1 time/200ml).
[11] Observation.
Interventions/Control_2
[1] Oral ingestion of a test food A (1 time/200ml).
[2] Observation.
[3] Washout (over 2days)
[4] Oral ingestion of a placebo food (1 time/200ml).
[5] Observation.
[6] Washout (over 2days)
[7] Oral ingestion of a test food B (1 time/200ml).
[8] Observation.
[9] Washout (over 2days)
[10] Oral ingestion of a placebo food (1 time/200ml).
[11] Observation.
Interventions/Control_3
[1] Oral ingestion of a test food B (1 time/200ml).
[2] Observation.
[3] Washout (over 2days)
[4] Oral ingestion of a test food A (1 time/200ml).
[5] Observation.
[6] Washout (over 2days)
[7] Oral ingestion of a placebo food (1 time/200ml).
[8] Observation.
[9] Washout (over 2days)
[10] Oral ingestion of a placebo food (1 time/200ml).
[11] Observation.
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
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1]Males and females aged 20-34 years.
[2]Individuals who are healthy and are not suffered from a chronic malady including skin disease.
[3]Individuals whose BMI is less than 25.0kg/m2.
[4] Individuals who are a non-smoker (no smoking in the last 1 year).
[5]Individuals whose written informed consent has been obtained.
[6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1]Individuals using medical products.
[2] Individuals who use a drug and Chinese traditional medicine.
[3]Individuals who receive a diet remedy and an exercise therapy under medical supervision.
[4]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[6]Individuals who are a patient or have a history of or endocrine disease.
[7]Individuals who use implantable medical devices such as a pacemaker.
[8]Individuals who used a drug to treat a disease in the past 1 month.
[9] Individuals who use regularly over-the-counter medicines, quasi-drugs, food for specified health uses, functional foods, health foods and other products that affect the autonomic nervous system, metabolism and sleep.
[10] Individuals who will develop seasonal allergy symptoms like hay fever or have allergic rhinitis during the test period.
[11]Individuals who are or may be allergic to medical products or foods.
[12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[13]Individuals whose diet is extremely irregular.
[14] Individuals whose daily life rhythm is irregular for reasons such as shift work or late nights.
[15] Individuals who have experienced significant stress due to life events within 3 months prior to obtaining informed consent.
[16]Individuals who are participating with other clinical trial.
[17]Individuals who cannot stop drinking from the day before the test.
[18]Individuals who are or are possibly pregnant, or are lactating.
[19]Individuals who have severe menstrual complaints (severe) and require medication.
[20]Individuals judged inappropriate for the study by the principal.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinc
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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
+81-3-6240-1162
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
| 2023 | Year | 04 | 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
| 2022 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 28 | 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 | 04 | Month | 06 | Day |
Last modified on
| 2022 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053987
