UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053807 |
|---|---|
| Receipt number | R000061391 |
| Scientific Title | Evalution of the effect of whey protein hydrolysate on feeling-related indices by single intake |
| Date of disclosure of the study information | 2024/03/08 |
| Last modified on | 2024/04/26 16:39:38 |
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Basic information
Public title
Evalution of the effect of whey protein hydrolysate on feeling-related indices by single intake
Acronym
Evalution of the effect of whey protein hydrolysate on feeling-related indices by single intake
Scientific Title
Evalution of the effect of whey protein hydrolysate on feeling-related indices by single intake
Scientific Title:Acronym
Evalution of the effect of whey protein hydrolysate on feeling-related indices by single intake
Region
| Japan |
Condition
Condition
Healthy adult males and females
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare foods with/ without whey protein hydrolysate on the usefulness for feeling -related indices by single intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS 2 short version
Key secondary outcomes
VAS
Acceleration pulse wave measurement
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Single intake of test food
Interventions/Control_2
Single intake of placebo (control 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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy males and females over the age of 30 and under the age of 60
2)Those whose T-score in DD of POMS 2 is higher than 50
3)Those who are judged as good health by the principal investigator or sub-investigator based on the results of medical examinations and tests including BDI-II
4)Those who are capable of keeping records on the electronic logbooks via PC, smart phone, etc.
5)Those who have been fully informed of the purpose and content of the study, have the capacity to consent, volunteer of their own free will with full knowledge of the content, and consent to participate in the study in writing
Key exclusion criteria
1)Those who consume pharmaceuticals, quasi-drugs, foods for health maintenance and recovery, and are unable to discontinue such consumption during the study period
2)Those who currently consume foods and drinks for the autonomic nervous system, sleep, metabolism, and intestinal environment, and are unable to discontinue such consumption during the study period
3)Those who have participated in studies including the ingestion of other foods or the use of cosmetics and pharmaceuticals within 1 month before the consent obtained, or who will participate in other studies during the study period
4)Heavy drinkers of alcohol
5)Those with irregular rhythm of daily life
6)Those who are habitual smokers
7)Those who plan to make major changes in their lifestyle during the study period
8)Those who have had a life event within 1 month that has affected them physically or mentally
9)Those who daily consume large amounts of milk, dairy products, or dairy-derived protein foods
10)Those who currently visit hospital and are on treatment for any disease
11)Those who have had surgery on the gastrointestinal tract (other than appendicitis surgery)
12)Those who are judged by the principal investigator or sub-investigator to have a disease associated with physical or mental disorder
13)Those who score 21 or higher on BDI-II
14)Those who are at risk of suicide on the 9th question of the BDI-II
15)Those with serious liver, kidney, heart, respiratory, endocrine, metabolic, psychiatric, or higher brain dysfunction
16)Those who have previously experienced feeling fainted, deterioration of physical condition, or vasovagal reflexes at the time of blood sampling
17)Those who may be allergic to milk or soy, or have lactose intolerant
18)Those with a current or history of allergy to drugs or foods
19)Those who are currently pregnant or lactating, and who wish to become pregnant during the study period
20)Those who are judged as ineligible for the study by the principal investigator
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Watanabe |
Organization
Watanabe Hospital
Division name
Surgery
Zip code
144-0043
Address
1-5-16, Haneda, Ota-ku, Tokyo, 144-0043, Japan
TEL
03-3741-0223
wnb.cto@gmail.com
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Koizumi |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027, Japan
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc
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
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, JAPAN
Tel
03-3741-0223
food-contact@apoplus.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
医療法人社団 渡辺病院(Watanabe Hospital)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 08 | 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
| 2024 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061391
