UMIN-CTR Clinical Trial

Basic information
Public title	Effects of functional food composition X and aerobic exercise on the risk for lifestyle disease
Acronym	Effects of functional food composition X and aerobic exercise on the risk for lifestyle disease
Scientific Title	Effects of functional food composition X and aerobic exercise on the risk for lifestyle disease
Scientific Title:Acronym	Effects of functional food composition X and aerobic exercise on the risk for lifestyle disease
Region	Japan

Condition
Condition	NO
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the combined effect of aerobic exercise with functional foods composition on arterial stiffness and related lifestyle disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Cardiovascular indices
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	4
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	Ingestion of functional food and aerobic exercise *Aerobic exercise training: 45-60min./day, 2 days/Weeks. *Intervention period: 12-week
Interventions/Control_2	Ingestion of placebo food and aerobic exercise *Aerobic exercise training: 45-60min./day, 2 days/Weeks. *Intervention period: 12-week
Interventions/Control_3	Ingestion of functional food (non-exercise) *Intervention period: 12-week
Interventions/Control_4	Ingestion of placebo food (non-exercise) *Intervention period: 12-week
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	70 years-old >
Gender	Female
Key inclusion criteria	Japanese women
Key exclusion criteria	1)Individuals who are restricted exercise by their doctors 2)Individuals who have anamnesis of cardiovascular disease 3)Individuals who are using hypertension or hormone medications 4)Smoker 5)Individuals who have allergic reaction to plant 6)Individuals who have a habit of daily vigorous exercises
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Koichiro Middle name Last name Hayashi
Organization	Kokugakuin University
Division name	Institute of Health and Physical Education, Department of Human Development
Zip code	225-0003
Address	3-22-1 Shin-Ishikawa, Aoba-ku, Yokohama, Kanagawa 225-0003, Japan
TEL	045-910-3732
Email	k-hayashi@kokugakuin.ac.jp

Public contact
Name of contact person	1st name Koichiro Middle name Last name Hayashi
Organization	Kokugakuin University
Division name	Institute of Health and Physical Education, Department of Human Development
Zip code	225-0003
Address	3-22-1 Shin-Ishikawa, Aoba-ku, Yokohama, Kanagawa 225-0003, Japan
TEL	045-910-3732
Homepage URL
Email	k-hayashi@kokugakuin.ac.jp

Sponsor
Institute	Kokugakuin University
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Border of Kokugakuin University
Address	4-10-28 Higashi, Shibuya-ku, Tokyo 150-8440, Japan
Tel	03-5466-6745
Email	https://www.kokugakuin.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	國學院大學 横浜たまプラーザキャンパス（神奈川県）(Yokohama Tama Plaza Campus of Kokugakuin University (Kanagawa Prefecture))

Other administrative information
Date of disclosure of the study information	2024 Year 12 Month 31 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	Open public recruiting
Date of protocol fixation	2021 Year 09 Month 01 Day
Date of IRB	2021 Year 09 Month 28 Day
Anticipated trial start date	2021 Year 12 Month 18 Day
Last follow-up date	2023 Year 12 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	2022 Year 10 Month 14 Day
Last modified on	2022 Year 10 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056057