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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032488
Receipt No. R000037046
Scientific Title The effect of lactotripeptides ingestion on vascular function in obese man
Date of disclosure of the study information 2018/06/01
Last modified on 2018/11/05

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Basic information
Public title The effect of lactotripeptides ingestion on vascular function in obese man
Acronym The effect of lactotripeptides ingestion on vascular function in obese man
Scientific Title The effect of lactotripeptides ingestion on vascular function in obese man
Scientific Title:Acronym The effect of lactotripeptides ingestion on vascular function in obese man
Region
Japan

Condition
Condition Obesity
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effect of lactotripeptides ingestion on vascular function in obese man
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [Before and after the 12-week intervention]
- Arterial function
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 Educational,Counseling,Training
Type of intervention
Food
Interventions/Control_1 Lactotripeptides ingestion (4.8 mg/d), 12 weeks
Interventions/Control_2 Placebo ingestion, 12 weeks
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
65 years-old >=
Gender Male
Key inclusion criteria BMI range: 25.0-34.9 kg/m2
Key exclusion criteria Have a cardiovascular and cerebrovascular disease, lactose intolerance
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Maeda
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-2683
Email maeda.seiji.gn@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Tanahashi
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-5990
Homepage URL
Email kouichita0305@yahoo.co.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Asahi Group Holdings 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
Address
Tel
Email

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
2018 Year 06 Month 01 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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 07 Day
Last modified on
2018 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037046

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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