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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037201
Receipt No. 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

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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
Email 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
Email makoto.yamaguchi@meiji.com

Sponsor
Institute Meiji Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042411

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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