UMIN-CTR Clinical Trial

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
Institute	University of Tsukuba, Faculty of Health and Sport Sciences, Division of Sport Medicine
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025698