UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052861 |
|---|---|
| Receipt number | R000060323 |
| Scientific Title | A placebo controlled, double blind, comparative trial concerning safety verification of long-term intake of protein hydrolyzate |
| Date of disclosure of the study information | 2023/12/12 |
| Last modified on | 2024/05/30 18:31:39 |
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Basic information
Public title
A placebo controlled, double blind, comparative trial concerning safety verification of long-term intake of protein hydrolyzate
Acronym
A placebo controlled, double blind, comparative trial concerning safety verification of long-term intake of protein hydrolyzate
Scientific Title
A placebo controlled, double blind, comparative trial concerning safety verification of long-term intake of protein hydrolyzate
Scientific Title:Acronym
A placebo controlled, double blind, comparative trial concerning safety verification of long-term intake of protein hydrolyzate
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety of long-term intake of whey protein hydrolysate containing 2.5 mg novel peptide for 12 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Body Weight, BMI, Body fat percentage
-Blood pressure, Pulse
-Hematology test
-Blood biochemical test
-General urine test
-Adverse event
Key secondary outcomes
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
Take 4 capsules test food between meals per day with water.
Interventions/Control_2
Take 4 capsules placebo food between meals per day with water.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy male and female aged 20 years or older on the date of consent acquisition.
2. Individuals able to input electronic diaries via PCs, smartphones etc.
3. Individuals who have received a sufficient explanation of the purpose and content of the trial, have the capacity to consent, have a good understanding, voluntarily wish to participate, and have consented in writing to participate in the trial.
Key exclusion criteria
1. Individuals currently taking commercial pharmaceuticals and quasi-drugs, health foods and supplements aimed at maintaining and recovering health, and unable to discontinue use during the trial period.
2. Individuals who have participated in experiments consuming other foods or using pharmaceuticals, applying cosmetics and pharmaceuticals etc. within one month from the day of consent, or intends to participate in other trials during this trial.
3. Individuals who consume large amounts of alcohol (equivalent to 40 g or more of alcohol per day).
4. Individuals with irregular lifestyles such as shift work, night work, etc.
5. Individuals with smoking habits (those who are less than one year after quitting).
6. Individuals planning major lifestyle changes (diet, sleep, exercise habits etc.) during the trial period, such as long trips.
7. Individuals who consume large amounts of milk, dairy products, or protein foods derived from milk every day (for example, over 1 L / day of milk, over 500 g / day of yogurt, or over 20 g / day of protein foods).
8. Individuals who have undergone gastrointestinal surgery, however, appendectomy is acceptable.
9. Individuals currently under treatment with any medications or Chinese medicines, however, instant use is acceptable.
10. Individuals with serious liver, kidney, heart, respiratory, endocrine, metabolic diseases, mental illnesses, or higher brain dysfunction.
11. Individuals with a history of treatment for heart failure, myocardial infarction, etc.
12. Individuals who have experienced discomfort or health deterioration, or vasovagal reflex due to blood collection.
13. Individuals likely to show symptoms of milk/soy allergy, or who have lactose intolerance.
14. Individuals with a current or history of drug or food allergies.
15. Individuals currently pregnant or breastfeeding, or wishing to become pregnant during the trial period.
16. Individuals deemed inappropriate as research subjects by the study's principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Suzuki |
Organization
AJINOMOTO CO., INC.
Division name
Functional Ingredients Development Group Wellness Value Creation Center Institute of Food Sciences and Technologies Food Products Division
Zip code
210-8681
Address
1-1, Sizuki-cho, Kawasaki-ku, Kawasaki-shi
TEL
090-3317-5314
katsuya.suzuki.4w9@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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 | 12 | Month | 12 | 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
| 2023 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 21 | Day |
Last modified on
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060323
