UMIN-CTR Clinical Trial

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
Last 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
Email	midori.natsume@meiji.com

Public contact
1st 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
Email	imai@croee.com

Sponsor
Institute	CROee.INC
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036990