UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022168 |
|---|---|
| Receipt number | 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 10:29:43 |
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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
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
ishikawa@hc-sys.jp
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025543
