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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022168
Receipt No. R000025543
Scientific Title Effect of consumption of Cacao 72% dark chocolate for 4 weeks on blood pressure, fasting serum lipid profile, cognitive function, and markers of oxidative stress and inflammation in Japanese 45-69 subjects: single group pre-post trial
Date of disclosure of the study information 2016/05/02
Last modified on 2016/05/02

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Basic information
Public title Effect of consumption of Cacao 72% dark chocolate for 4 weeks on blood pressure, fasting serum lipid profile, cognitive function, and markers of oxidative stress and inflammation in Japanese 45-69 subjects: single group pre-post trial
Acronym Effect of consumption of Cacao 72% dark chocolate for 4 weeks on blood pressure, fasting serum lipid profile, cognitive function, and markers
Scientific Title Effect of consumption of Cacao 72% dark chocolate for 4 weeks on blood pressure, fasting serum lipid profile, cognitive function, and markers of oxidative stress and inflammation in Japanese 45-69 subjects: single group pre-post trial
Scientific Title:Acronym Effect of consumption of Cacao 72% dark chocolate for 4 weeks on blood pressure, fasting serum lipid profile, cognitive function, and markers
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to evaluate the effects of dark chocolate consumption on blood pressure, fasting serum lipid profile, cognitive function, and markers of oxidative stress and inflammation in Japanese 45-69 subjects.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Blood pressure (systolic blood pressure, diastolic blood pressure) and insulin resistance index (HOMA-IR, QUICKI) after 4 weeks of intervention
Key secondary outcomes Glucose, Insulin, Blood Lipid (Total cholesterol, HDL-Cholesterol, LDL-cholesterol, Triglyceride), Brain Derived Neurotrophic Factor
Hs-CRP, 8-OHdG, SF-36

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 72% Cacao Dark chocolate 25 g/day for 4 weeks
Interventions/Control_2
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
45 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Persons who give written informed consent, and have full ethical and regulatory approval
2. Persons who are currently health adults and 45-69 years
Key exclusion criteria 1. Persons who are currently medication for chronic disease
2. Persons who take pharmaceuticals, dairy supplement, health-promoting diet and health food for the purpose of health maintenance related to the test food of this trial within the last three months
3. Persons who were enrolled into other clinical trials within the last one month before agreeing to participate in this trial
4. Persons who are allergic to cacao products to the test food of this trial, milk protein, and soybean
5. Persons who took the cacao products daily in large quantity
6. Persons who are pregnant, or planning to get pregnant during the trial period
7. Persons who are lactating
8. Persons who are judged unsuitable for participating in this trial by physician
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Kawabe
Organization Gamagori City Hospital
Division name Department of pediatrics
Zip code
Address 1-1 Mukaida, Hirata-cho, Gamagori-shi, Aichi, 443-8501, JAPAN
TEL 0533-66-2200
Email hospital@city.gamagori.lg.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohito Ishikawa
Organization Healthcare Systems Co., Ltd.
Division name Research and Development
Zip code
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, 105-0004, JAPAN
TEL 03-6809-2722
Homepage URL
Email ishikawa@hc-sys.jp

Sponsor
Institute Meiji Co., Ltd.
Institute
Department

Funding Source
Organization Meiji Co., Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Gamagori City Hall
Gamagori City Hospital
Healthcare Systems Co., Ltd.
Aichi Gakuin University
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 蒲郡市民病院(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 02 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2014 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 23 Day
Last follow-up date
2014 Year 07 Month 19 Day
Date of closure to data entry
2015 Year 02 Month 10 Day
Date trial data considered complete
2015 Year 02 Month 27 Day
Date analysis concluded
2015 Year 03 Month 24 Day

Other
Other related information

Management information
Registered date
2016 Year 05 Month 02 Day
Last modified on
2016 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025543

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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