UMIN-CTR Clinical Trial

Basic information
Public title	Effects on postprandial blood glucose and triglyceride levels of confectionery made using Naked barley grown in Ehime prefecture for healthy subjects: crossover, placebo controlled randomized clinical trial
Acronym	Effects on postprandial blood glucose triglyceride levels of confectionery made using Naked barley grown for healthy subjects: randomized clinical trial
Scientific Title	Effects on postprandial blood glucose and triglyceride levels of confectionery made using Naked barley grown in Ehime prefecture for healthy subjects: crossover, placebo controlled randomized clinical trial
Scientific Title:Acronym	Effects on postprandial blood glucose triglyceride levels of confectionery made using Naked barley grown for healthy subjects: randomized clinical trial
Region	Japan

Condition
Condition	Postprandial blood glucose and triglyceride levels
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to examine the effects on postprandial blood glucose and triglyceride levels of confectionery made using Naked barley grown in Ehime prefecture compared with confectionery without Naked barley for healthy subjects by crossover, placebo controlled randomized clinical trial
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postprandial blood glucose and triglyceride levels, and their area under the curve
Key secondary outcomes	1.Postprandial blood insulin level, and its area under the curve 2.Subjective appetite change after test meals 3. Gastrointestinal symptoms after test meals

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Firstly, the participants eat the test meal (bread 25g and butter 10g). After eating test meal, the participants subsequently eat confectionery made using Naked barley (102g) in the intervention group.
Interventions/Control_2	Firstly, the participants eat the test meal (bread 25g and butter 10g). After eating test meal, the participants subsequently eat placebo confectionery made using wheat (95g) in the control group.
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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy men and women of 20 to 69 years of age at entry
Key exclusion criteria	1. Body mass index less than 18.5 kg / m 2, or, over 30 kg / m 2 2. Persons undergoing treatment for hypertension, dyslipidemia, diabetes, cancer, ischemic heart disease, cerebrovascular disease, chronic kidney disease, dementia, severe digestive system diseases 3. Women during pregnancy or lactation period 4. Food allergy of food to be provided (wheat, barley, peanuts, eggs) 5. The physician consider the individuals as inappropriate.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koutatsu Maruyama
Organization	Ehime University
Division name	Laboratory of Community Health and Nutrition, Special Course of Food and Health Science Department of Bioscience, Graduate School of Agriculture
Zip code
Address	3-5-7 Tarumi, Matsuyama, Ehime
TEL	089-946-9960
Email	maruyama.kotatsu.rt@ehime-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Koutatsu Maruyama
Organization	Ehime University
Division name	Laboratory of Community Health and Nutrition, Special Course of Food and Health Science Department o
Zip code
Address	3-5-7 Tarumi, Matsuyama, Ehime
TEL	089-946-9960
Homepage URL
Email	maruyama.kotatsu.rt@ehime-u.ac.jp

Sponsor
Institute	Ehime University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 01 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	No longer recruiting
Date of protocol fixation	2018 Year 11 Month 30 Day
Date of IRB	2019 Year 03 Month 01 Day
Anticipated trial start date	2019 Year 03 Month 21 Day
Last follow-up date	2019 Year 06 Month 01 Day
Date of closure to data entry	2019 Year 06 Month 30 Day
Date trial data considered complete	2019 Year 08 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 03 Month 09 Day
Last modified on	2019 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041171