UMIN-CTR Clinical Trial

Basic information
Public title	Research on the effect of cacao product intake on postprandial hyperglycemia.
Acronym	Effect of cacao product intake on postprandial hyperglycemia
Scientific Title	Research on the effect of cacao product intake on postprandial hyperglycemia.
Scientific Title:Acronym	Effect of cacao product intake on postprandial hyperglycemia
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the influence of intake of high cacao chocolate on changes in plasma glucose levels induced by oral glucose tolerance test.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma glucose levels
Key secondary outcomes	Serum insulin levels, non-esterified free fatty acid concentration, glucagon concentration, GLP-1 concentration

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral glucose tolerance test after intake of high cacao chocolate
Interventions/Control_2	Only oral glucose tolerance test
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	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	Subjects who competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents.
Key exclusion criteria	1) Subjects who are under treatment for chronic disorders 2) Subjects whose HbA1c level is greater than 6.5% at the second screening 3) Subjects whose blood glucose level is greater than 126 mg/dl when fasting at the second screening 4) Subjects who are allergic to chocolate, milk, soybeans, wheat, beef, chicken, pork, salmon, crab, banana, apples, and oranges 5) Subjects with headache induced by intake of chocolates 6) Subjects who highly intake cacao products on a daily basis (high cacao chocolate: 70 g or more/ week, milk chocolate :140 g or more/ week) 7) Subjects taking medicines (such as hypoglycemic drugs) with function claims that potentially influence the outcome of this study on a daily basis, or those who intend to take these during this study 8) Subjects whose sexual cycle is unstable (persons with sex cycle other than 28 days) 9) Subjects who have participated in other clinical and monitoring studies within 1 month before screening or who plan to participate in other clinical trials after this clinical trial consent 10) Subjects who are pregnant, or plan to get pregnant during the study period 11) Subjects who are breast-feeding 12) Alcohol-heavy drinkers (drinkers with an average daily of over 60 g in terms of pure alcohol) 13) Subjects who are judged as ineligible by the examination director and doctors
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hidekazu Arai
Organization	The University of Shizuoka
Division name	Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	054-264-5511
Email	arai@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hidekazu Arai
Organization	The University of Shizuoka
Division name	Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	054-264-5511
Homepage URL
Email	arai@u-shizuoka-ken.ac.jp

Sponsor
Institute	The University of Shizuoka
Institute
Department

Funding Source
Organization	Meiji Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

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	浅井内科医院 福地皮ふ科クリニック 福地外科循環器医院

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 31 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
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 03 Month 09 Day
Date of IRB	2018 Year 02 Month 07 Day
Anticipated trial start date	2018 Year 05 Month 28 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 05 Month 28 Day
Last modified on	2020 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037350