UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Vanilla ice cream containing oligosaccharides on postprandial blood glucose
Acronym	Effect of Vanilla ice cream containing oligosaccharides on postprandial blood glucose
Scientific Title	Effect of Vanilla ice cream containing oligosaccharides on postprandial blood glucose
Scientific Title:Acronym	Effect of Vanilla ice cream containing oligosaccharides on postprandial blood glucose
Region	Japan

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

Objectives
Narrative objectives1	To examine the on blood glucose parameters of healthy adult men
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose levels (change of blood glucose and delta postprandial blood glucose, incremental AUC, Cmax and delta Cmax, Tmax)
Key secondary outcomes	Blood glucose levels (total AUC) Serum insulin levels (change of insulin secretion and delta values, incremental AUC, total AUC)

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Vanilla ice cream containing fructooligosaccharide
Interventions/Control_2	Vanilla ice cream non-containing fructooligosaccharide
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	Not applicable
Gender	Male
Key inclusion criteria	1) Subjects whose written informed consent has been obtained 2) Subjects who are males aged more than 20 years old 3) Subjects who are employee at Meiji Co., Ltd, Meiji Holdings Co., Ltd. or Meiji Food Materia Co., Ltd.
Key exclusion criteria	1) Subjects who are under treatment for chronic medical diseases or have a history of serious diseases 2) Subjects Who have food allergy 3) Subjects who are aware of lactose intolerance 4) Subjects who suffer abdominal symptom when take of cold food 5) Subjects who are heavy drinkers with an average daily of over 60 g in terms of pure alcohole 6) Subjects whose fasting blood glucose levels are less than 70 mg/dL or more than 110 mg/dL 7) Subjects who have experienced abdominal symptoms when take of fructooligosaccharide 8) Subjects who are current smoker 9) Subjects who had participated in other clinical trials within 1 month 10) Subjects who can not insert Peripheral Intra Venous Catheterization 11) Subjects who are judged unsuitable for this study by rrincipal investigator or doctor
Target sample size	14

Research contact person
Name of lead principal investigator	1st name Midori Middle name Last name Natsume
Organization	Meiji Co., Ltd
Division name	Gropu 2 Health Science Researc Department Food Microbiology and Function Research Laboratories
Zip code	192-0919
Address	1-29-1, nanakuni, hatiouji City, Tokyo
TEL	042-632-5850
Email	midori.natsume@meiji.com

Public contact
Name of contact person	1st name Midori Middle name Last name Natsume
Organization	Meiji Co., Ltd
Division name	Gropu 2 Health Science Researc Department Food Microbiology and Function Research Laboratories
Zip code	192-0919
Address	1-29-1, nanakuni, hatiouji City, Tokyo
TEL	042-632-5850
Homepage URL
Email	midori.natsume@meiji.com

Sponsor
Institute	Meiji Co., Ltd
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	Meiji Institutional Review Board
Address	1-29-1, Nanakuni, Hatiouji City, Tokyo
Tel	042-632-5900
Email	MEIJI.IRB@meiji.com

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	2019 Year 12 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	14
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	2019 Year 06 Month 21 Day
Date of IRB	2019 Year 06 Month 26 Day
Anticipated trial start date	2019 Year 07 Month 16 Day
Last follow-up date	2019 Year 08 Month 28 Day
Date of closure to data entry	2019 Year 08 Month 29 Day
Date trial data considered complete	2019 Year 09 Month 06 Day
Date analysis concluded	2019 Year 10 Month 16 Day

Other
Other related information

Management information
Registered date	2019 Year 07 Month 12 Day
Last modified on	2020 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042586