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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026486
Receipt No. R000030420
Scientific Title The effect of regular high cacao-content chocolate ingestion on arterial stiffness and metabolic responses in exercise.
Date of disclosure of the study information 2017/03/27
Last modified on 2019/01/09

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Basic information
Public title The effect of regular high cacao-content chocolate ingestion on arterial stiffness and metabolic responses in exercise.
Acronym The effect of high cacao-content chocolate.
Scientific Title The effect of regular high cacao-content chocolate ingestion on arterial stiffness and metabolic responses in exercise.
Scientific Title:Acronym The effect of high cacao-content chocolate.
Region
Japan

Condition
Condition Healthy young adult population
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of regular high cacao-content chocolate ingestion on arterial stiffness and metabolic responses in exercise.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Arterial stiffness (after 4 week)
Key secondary outcomes Respiratory gas responses in exercise (after 4 week)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Behavior,custom
Interventions/Control_1 No treatment, 4 week
Interventions/Control_2 High cacao-content chocolate ingestion (20 g/day), 4 week
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 18 years and older men and women, not restricted by a doctor from exercising, not have medication and smoking.
Key exclusion criteria Have a cardiovascular and cerebrovascular disease.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Nishiwaki
Organization Osaka Institute of Technology
Division name Faculty of Engineering
Zip code
Address 5-16-1 Ohmiya, Asahi-ku, Osaka
TEL 06-6954-4391
Email masato.nishiwaki@oit.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masato Nishiwaki
Organization Osaka Institute of Technology
Division name Faculty of Engineering
Zip code
Address 5-16-1 Ohmiya, Asahi-ku, Osaka
TEL 06-6954-4391
Homepage URL
Email masato.nishiwaki@oit.ac.jp

Sponsor
Institute Faculty of Engineering, Osaka Institute of Technology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.sciencedirect.com/science/article/pii/S0899900718309419?via%3Dihub
Number of participants that the trial has enrolled
Results
First, we examined the effects of ingesting high-cacao chocolate on arterial stiffness in young healthy men. After 4 weeks of ingestion, arterial stiffness did not change in the Control group. However, arterial stiffness significantly reduced in the Intervention group.
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
2017 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 23 Day
Last follow-up date
2017 Year 04 Month 10 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 07 Month 31 Day
Date analysis concluded
2018 Year 08 Month 24 Day

Other
Other related information Second, we examined the effects of ingesting high-cacao chocolate on metabolic characteristics during exercise in young healthy people. After 4 weeks of ingestion, metabolic characteristics during exercise did not change in both groups.

Management information
Registered date
2017 Year 03 Month 09 Day
Last modified on
2019 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030420

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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