UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054529 |
|---|---|
| Receipt number | R000062299 |
| Scientific Title | Measurement of the effects of foods containing processed whey protein on metabolism in healthy subjects |
| Date of disclosure of the study information | 2024/06/02 |
| Last modified on | 2024/05/31 13:50:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Measurement of the effects of foods containing processed whey protein on metabolism in healthy subjects
Acronym
Measurement of the effects of foods containing processed whey protein on metabolism in healthy subjects
Scientific Title
Measurement of the effects of foods containing processed whey protein on metabolism in healthy subjects
Scientific Title:Acronym
Measurement of the effects of foods containing processed whey protein on metabolism in healthy subjects
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the same effects on lipid metabolism that were observed in animal studies can be obtained in humans by collecting and analyzing the respiratory gases of healthy subjects before and after ingestion of processed whey protein products and control foods
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Respiratory gas analysis values (absolute and per body weight values of oxygen consumption, carbohydrate oxidation, lipid oxidation, and energy consumption, and respiratory exchange ratio)
2. The change in respiratory gas analysis values (excluding the respiratory exchange ratio) after the intake of the test food, when the values measured before the intake of the test food are set to 100%
Key secondary outcomes
[Efficacy]
1. Absolute value of the VAS questionnaire regarding the change in physical condition before and after the intake of the test food
2. The relative value of the VAS questionnaire on the change in physical condition before and after the intake of the test food, when the value measured before the intake of the test food is set as 100%
[Safety]
Adverse events and side effects
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Phase I: Taking experimental food
Wash out phase: About 1 week or more
Phase II: Taking control food
Interventions/Control_2
Phase I: Taking control food
Wash out phase: About 1 week or more
Phase II: Taking experimental food
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy persons between the ages of 20 and 30
Key exclusion criteria
(1)Those who regularly take specified health foods, functional foods, or health foods (including supplements) that may affect the study at least 3 times a week and cannot discontinue taking them from the time of obtaining consent
(2)Those who are taking medicines (e.g. antibiotics, intestinal preparations, laxatives, etc.) at least 3 times a week that could potentially affect the study and who are unable to limit their use of such medicines during the study period
(3)Heavy drinkers of alcohol
(4)Those with a history or current history of serious diseases of the heart, liver, kidney, digestive organs, etc
(5)Pregnant, lactating, or intending to become pregnant during the study period
(6)Persons with allergies (dairy, egg, soy, shrimp, crab, wheat, pork, chicken)
(7)Persons who are deemed unsuitable for participation in the study by the study's principal investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Fuminori |
| Middle name | |
| Last name | Kawabata |
Organization
Hirosaki University
Division name
Department of International Agriculture and Horticulture, Faculty of Agriculture and Life Science
Zip code
036-8561
Address
3 Bunkyo-cho, Hirosaki, Aomori
TEL
0172-39-3805
kawabata@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Fuminori |
| Middle name | |
| Last name | Kawabata |
Organization
Hirosaki University
Division name
Department of International Agriculture and Horticulture, Faculty of Agriculture and Life Science
Zip code
036-8561
Address
3 Bunkyo-cho, Hirosaki, Aomori
TEL
0172-39-3805
Homepage URL
kawabata@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
Funding Source
Organization
UHA mikakuto. Co., 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
| 2024 | Year | 06 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062299
