UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018673 |
|---|---|
| Receipt number | 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 12:09:03 |
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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
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
m.i@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021619
