UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022313
Receipt number R000025698
Scientific Title The effect of aerobic exercise training and lactotripeptides ingestion on vascular function.
Date of disclosure of the study information 2016/05/17
Last modified on 2020/07/14 15:30:58

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Basic information

Public title

The effect of aerobic exercise training and lactotripeptides ingestion on vascular function.

Acronym

The effect of exercise and lactotripeptides.

Scientific Title

The effect of aerobic exercise training and lactotripeptides ingestion on vascular function.

Scientific Title:Acronym

The effect of exercise and lactotripeptides.

Region

Japan


Condition

Condition

Healthy middle-aged and older population.

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the effect of the combination of exercise and lactotripeptides on vascular function.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cerebral hemodynamics (8 week after intervention)

Key secondary outcomes

Arterial stiffness (8 week after intervention)


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food Behavior,custom

Interventions/Control_1

Placebo (Casein) ingestion, 8 weeks

Interventions/Control_2

Lactotripeptides ingestion (4.8 mg/d), 8weeks

Interventions/Control_3

Placebo (Casein) ingestion, 8 weeks
Aerobic exercise (Moderate intensity, 30-50 min, 4-6 d/w), 8weeks

Interventions/Control_4

Lactotripeptides ingestion (4.8 mg/d), 8weeks
Aerobic exercise (Moderate intensity, 30-50 min, 4-6 d/w), 8weeks

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

50 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

50 years and older men, postmenopausal women, not restricted by a doctor from exercising, not have medication, smoking, and exercise habits

Key exclusion criteria

Have a cardiovascular and cerebrovascular disease, lactose intolerance

Target sample size

90


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

3058574

Address

1-1-1 Tennodai, Tsukuba, Ibaraki

TEL

029-853-2683

Email

maeda@taiiku.tsukuba.ac.jp


Public contact

Name of contact person

1st name Nobuhiko
Middle name
Last name Akazawa

Organization

University of Tsukuba

Division name

Faculty of Health and Sport Sciences

Zip code

3058574

Address

1-1-1 Tennodai, Tsukuba, Ibaraki

TEL

029-853-5990

Homepage URL


Email

nobuhiko.akazawa@jpnsport.go.jp


Sponsor or person

Institute

University of Tsukuba,
Faculty of Health and Sport Sciences,
Division of Sport Medicine

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

Ethcal commitee of University of Tsukuba

Address

1-1-1 Tennodai, Tsukuba

Tel

029-853-2571

Email

hitorinri@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

筑波大学総合研究棟D


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 17 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

2016 Year 05 Month 10 Day

Date of IRB

2014 Year 05 Month 09 Day

Anticipated trial start date

2016 Year 05 Month 16 Day

Last follow-up date

2016 Year 09 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2017 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 05 Month 14 Day

Last modified on

2020 Year 07 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025698


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name