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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018673
Receipt No. R000021619
Scientific Title 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.
Date of disclosure of the study information 2015/08/20
Last modified on 2018/08/09

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Basic information
Public title 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.
Acronym Investigation of the effectiveness of whole wheat bread intake for 12 weeks against metabolic syndrome index.
Scientific Title 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name Katsuhisa Sakano
Organization CPCC Company Limited
Division name Clinical Research Planning Department
Zip code
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
1st name
Middle name
Last name Makoto Ichinohe
Organization CPCC Company Limited
Division name Plan Sales Department
Zip code
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)

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
2015 Year 08 Month 20 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
2015 Year 08 Month 03 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000021619

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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