UMIN-CTR Clinical Trial

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 Masato Middle name Last name Nishiwaki
Organization	Osaka Institute of Technology
Division name	Faculty of Engineering
Zip code	535-8585
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 Masato Middle name Last name Nishiwaki
Organization	Osaka Institute of Technology
Division name	Faculty of Engineering
Zip code	535-8585
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	Osaka Institute of Technology
Address	5-16-1 Ohmiya, Asahi-ku, Osaka
Tel	06-6954-4391
Email	masato.nishiwaki@oit.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	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	2020 Year 12 Month 24 Day

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