UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037201 |
|---|---|
| Receipt number | R000042411 |
| Scientific Title | Effect of tablets containing whey peptides on rehydration |
| Date of disclosure of the study information | 2019/06/27 |
| Last modified on | 2020/02/17 16:02:09 |
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Basic information
Public title
Effect of tablets containing whey peptides on rehydration
Acronym
Effect of tablets containing whey peptides on rehydration
Scientific Title
Effect of tablets containing whey peptides on rehydration
Scientific Title:Acronym
Effect of tablets containing whey peptides on rehydration
Region
| Japan |
Condition
Condition
Healthy adult males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to assess the effect of the tablets containing whey peptides on the decrease of body fluid in healthy men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma volume change, serum total protein, serum albumin, body weight change, urine volume, serum Na, serum osmolality, serum insulin, serum glucose, FENa, creatinine clearance, free water clearance, eardrum temperature, subjective symptoms (feelings of fatigue, thirst, pain in foot muscle, heat, and abdominal distension), POMS2
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single dose administration of the test food in intervention period. The weight of administrated water is equal to the decreased body weight by the exercise. The number of taken tablets is one per 50 mL of administrated water.
Interventions/Control_2
In control test, oral ingestion of water whose volume is equal to the body weight loss by exercise.
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
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
1) Subjects whose written informed consent has been obtained
2) Subjects who are males aged 20-49 years
3) Subjects whose BMI is between 18.5 and 25.0 kg/m2
Key exclusion criteria
1) Subjects who have serious or progressive diseases or symptoms
2) Subjects who have cardiovascular or kidney diseases
3) Subjects received dietary counselling
4) Subjects who cannot exercise with cycle ergometer
5) Subjects who have food allergy
6) Subjects who donated 200 mL blood within 1 month or 400 mL blood within 3 months before starting of this test
7) Subjects who joined other clinical tests within 1 month before starting of this test
8) Subjects who are smoker
9) Subjects judged inappropriate for this study by the principal
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Shukuko |
| Middle name | |
| Last name | Ebihara |
Organization
Chiyoda para medical care clinic
Division name
Chiyoda para medical care clinic
Zip code
101-0047
Address
2F, Sanwa-Uchikanda Bldg 3-3-5 Uchikanda, Chiyodaku, Tokyo 101-0047, Japan
TEL
03-5297-5548
m.n@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Yamaguchi |
Organization
Meiji Co., Ltd.
Division name
Food Microbiology and Function Research Laboratories, R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo
TEL
042-632-5849
Homepage URL
makoto.yamaguchi@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919
Tel
042-632-5900
MEIJI.IRB@meiji.com
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
| 2019 | Year | 06 | Month | 27 | 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
| 2019 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 18 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 24 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 27 | Day |
Last modified on
| 2020 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042411
