UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032488
Receipt number 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 2023/11/14 14:36:07

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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 Seiji
Middle name
Last name Maeda

Organization

University of Tsukuba

Division name

Faculty of Health and Sport Sciences

Zip code

305-8577

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 Koichiro
Middle name
Last name Tanahashi

Organization

University of Tsukuba

Division name

Faculty of Health and Sport Sciences

Zip code

305-8577

Address

1-1-1 Tennodai, Tsukuba, Ibaraki

TEL

029-853-5990

Homepage URL


Email

kouichita0305@yahoo.co.jp


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



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

University of Tsukuba

Address

1-1-1 Tennodai, Tsukuba, Ibaraki

Tel

029-853-2572

Email

takano.nobuo.ka@un.tsukuba.ac.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

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

51

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

Main results already published

Date of protocol fixation

2018 Year 05 Month 01 Day

Date of IRB

2018 Year 03 Month 28 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2018 Year 10 Month 31 Day

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

2023 Year 11 Month 14 Day



Link to view the page

Value
https://center6.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