UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the effectiveness of whole wheat bread intake for 12 weeks against metabolic syndrome index: Effects on visceral fat area, fasting blood glucose and serum lipids.
Title of the study (Brief title)	Investigation of the effectiveness of whole wheat bread intake for 12 weeks against metabolic syndrome index.
Region	Japan

Condition
Condition	Healthy subjects ( BMI >= 23.0 kg/m2)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of the effectiveness of whole wheat bread intake for 12 weeks against metabolic syndrome index.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	metabolic syndrome index (visceral fat area, serum lipids) It will be measured at week 0, 6, and 12.
Key secondary outcomes	Blood HbA1c, serum insulin, leptin, adiponectin levels, fasting blood glucose, blood pressure

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	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of approximately 100 grams of whole wheat bread twice a day for 12 weeks.
Interventions/Control_2	Intake of approximately 100 grams of wheat flour bread twice a day for 12 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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Aged between 20 and 64 years old at consent. (2) BMI >= 23.0 kg/m2 (3) Subjects who understand the study procedures and agree to participate in the study by giving informed consent prior to the study.
Key exclusion criteria	(1) Subjects who have continuous intake of Divaricate Saposhnikovia Miraculous Powder. (2) Subjects who take drugs to treat dyslipidemia. (3) Subjects who experienced body weight changes >= 10% within a year before the start date of this study. (4) Fasting blood glucose >=126 mg/dl or HbA1c (NGSP) >=6.5% or diabetic patient. (5) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (6) Subjects who have history of surgery in gastrointestinal tract. (7) Subjects who have history of malignant diseases. (8) Females who are pregnant or lactating, and who could become pregnant or lactating during test period. (9) Subjects who have excessive alcohol intake. (10) Subjects who have extremely irregular dining habits, and who have midnight work or irregular shift work. (11) Subjects who have continuous intake of dietary fiber supplement or whole grain. (12) Subjects who have serious infectious diseases. (13) Subjects who have previous medical history of drug and/or food allergy. (14) Subjects who are participating in other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate in other clinical tests. (15) Subjects who donated over 200mL blood and/or blood components within the last one month. (16) Males who donated over 400mL blood within the last three month. (17) Females who donated over 400mL blood within the last four month. (18) Males who will be collected over 1200 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months. (19) Females who will be collected over 800 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months. (20) Subjects who are not eligible for this study for some medical reasons.
Target sample size	50

Research contact person
Name of lead principal investigator	Katsuhisa Sakano
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Address	4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL	03-5297-3112
Email	k.s@cpcc.co.jp

Public contact
Name of contact person	Makoto Ichinohe
Organization	CPCC Company Limited
Division name	Plan Sales Department
Address	4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL	03-5297-3112
Homepage URL
Email	m.i@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Research Project on Development of Agricultural Products and Foods with Health-promoting benefits
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Faculty of Home Economics, Otsuma Women's University
Name of secondary funｄer(s)

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	2015 Year 08 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 03 Day
Anticipated trial start date	2015 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 14 Day
Last modified on	2018 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021619