UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032440 |
|---|---|
| Receipt number | R000036990 |
| Scientific Title | A study to investigate the impact of chocolate intake on blood pressure |
| Date of disclosure of the study information | 2018/05/06 |
| Last modified on | 2019/04/22 09:53:42 |
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Basic information
Public title
A study to investigate the impact of chocolate intake on blood pressure
Acronym
A study to investigate the impact of chocolate intake on blood pressure
Scientific Title
A study to investigate the impact of chocolate intake on blood pressure
Scientific Title:Acronym
A study to investigate the impact of chocolate intake on blood pressure
Region
| Japan |
Condition
Condition
Subjects with high normal blood pressure and subjects with grade I hypertension
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess impact of 4 weeks continuous intake of chocolate on blood pressure of subjects with high normal blood pressure and subjects with grade I hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Systolic blood pressure
Key secondary outcomes
Diastolic blood pressure
HDL-cholesterol (HDL-C), LDL-cholesterol (LDL-C), hs-CRP
Subjective evaluation questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of chocolate (4 weeks).
Interventions/Control_2
Intake of placebo chocolate (4 weeks).
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents.
2) Subjects who are adults of both sexes above 40 years old- under 69 years old at the point of obtaining informed consent.
3) Subjects with high normal blood pressure or grade I hypertension at the point of screening(2)
High normal blood pressure: Systolic BP from 130 to 139 mmHg and/ or diastolic blood pressure from 85 to 89 mm Hg
Grade I hypertension : Systolic BP from 140 to 159 and/ or diastolic blood pressure from 90 to 99 mm Hg)
4) Subjects with BMI above 18.5 kg/ m2-under 30 kg/ m2 at the point of screening(1)
Key exclusion criteria
1) Subjects who are under treatment for chronic disorders
2) Subjects who are in pregnancy, lactation, or who are willing to become pregnant during this study
3) Subjects who participated in other clinical trial or monitor study within 1 month prior to screening(1)
4) Subject with allergy to cacao, milk constituent and soy
5) Subjects with lactose intolerance
6) Subjects who highly intake cacao products on a daily basis
7) Subjects who intake medical chemicals, quasi-drugs, supplements, health foods, foods for specified health uses, foods with function claims that potentially influence the outcome of this study within 3 month prior to the screening(1) on regular basis or subjects who plan to intake these during this study
8) Subjects who is ineligible for this study due to principal investigator's judgment
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Midori Natsume |
Organization
Meiji Co., Ltd.
Division name
Group 2 Health Science Research Department Food Science & Technology Research Laboratories R&D Division
Zip code
Address
1-29-1 Nanakuni,Hachiouji,Tokyo 192-0919,JAPAN
TEL
042-632-5850
midori.natsume@meiji.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Imai |
Organization
CROee.INC
Division name
Evidence Division
Zip code
Address
2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL
03-5953-2108
Homepage URL
imai@croee.com
Sponsor or person
Institute
CROee.INC
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
東京センタークリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 06 | 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
171
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
| 2018 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 01 | Day |
Last modified on
| 2019 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036990
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