UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the effect of milk chocolate containing fructooligosaccharides on postprandial blood glucose levels.
Acronym	Investigation of the effect of milk chocolate containing fructooligosaccharides on postprandial blood glucose levels.
Scientific Title	Investigation of the effect of milk chocolate containing fructooligosaccharides on postprandial blood glucose levels.
Scientific Title:Acronym	Investigation of the effect of milk chocolate containing fructooligosaccharides on postprandial blood glucose levels.
Region	Japan

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

Objectives
Narrative objectives1	To elucidate lower responses of postprandial glucose and insulin after ingestion of milk chocolate with fructooligosaccharides than those of milk chocolate without fructoligosaccharides.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference of area under the curve of blood glucose levels from baseline.
Key secondary outcomes	1.blood glucose levels (measured values, difference from baseline, area under the curve, Cmax, difference of Cmax of blood glucose levels from baseline, Tmax) 2.insulin levels (measured values, difference from baseline, area under the curve, difference of area under the curve of insulin levels from baseline, Cmax, difference of Cmax of insulin levels from baseline ,Tmax)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Test food : ingestion of chocolate containing fructooligosaccharides with plain hot water . > washout > Control food : ingention of chocolate non-containing fructooligosaccharides with plain hot water.
Interventions/Control_2	Control food : ingestion of chocolate non-containing fructooligosaccharides with plain hot water. > washout > Test food : ingention of chocolate containing fructooligosaccharides with plain hot water.
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	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Individuals who receive adequate explanation for the purpose and content of this trial and provide written informed consent for participation by their own free will. 2. Men and women over 30 years old. 3.Those with a fasting blood glucose level of less than 126 mg/dL and HbA1c of less than 6.5%. 4.Non smoker.
Key exclusion criteria	1.Individuals with chronic disease medication. 2.Individuals who take medicines that may affect blood glucose metabolism, take foods for specified health use or foods with functional claims, at least 5 days a week. 3.Individuals with food allergies caused by cocoa, dairy ingredients, soy, eggs, wheat, shrimp, crab, peanuts, buckwheat, almonds, oranges, cashews, kiwifruits, walnuts ,sesame, bananas, peaches, apple, and gelatin. 4.Individuals aware of FOS intolerance. 5.Individuals who can not eat 60g of chocolate. 6.Men less than 40 kg and women less than 30 kg in weight. 7.Individuals comprehensively judged by the investigator to have distinct abnormalities in BMI, blood pressure, hematology test values, and biochemical test values in the preliminary test. 8.Individuals who are pregnant or breastfeeding. 9.Individuals who have participated in other clinical trials within one month before obtaining consent to participate in this study, or those who plan to participate in other clinical studies between the acquisition of consent to participate in this study and the end of the second examination. 10.Others who are judged to be inappropriate as subjects by the investigator.
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Watanabe
Organization	Niigata Bio-Research Park, Inc
Division name	Advisor
Zip code	9560841
Address	316-2, Higashijima, Akiha-ku, Niigata, 956-0841, Japan
TEL	0250-25-1196
Email	wataken@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Goto
Organization	Niigata Bio-Research Park, Inc
Division name	Business promotion division
Zip code	9560841
Address	316-2, Higashijima, Akiha-ku, Niigata, 956-0841, Japan
TEL	0250-25-1196
Homepage URL
Email	goto@nbrp.co.jp

Sponsor
Institute	Niigata Bio-Research Park, 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	NBRC Research Ethcs Review Committee
Address	316-2, Higashijima, Akiha-uk, Niigata, 956-0841, Japan
Tel	0250-25-1196
Email	nbrp-food-navi@nbrp.co.jp

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

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 28 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	2020 Year 07 Month 20 Day
Date of IRB	2020 Year 07 Month 20 Day
Anticipated trial start date	2020 Year 08 Month 28 Day
Last follow-up date	2020 Year 12 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 27 Day
Last modified on	2021 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047404