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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025750
Receipt No. R000028884
Scientific Title Non-inferiority test of a cereal-derived processed product on visceral fat area :a randomized, double-blind, non-inferiority crossover study
Date of disclosure of the study information 2017/01/19
Last modified on 2019/08/26

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Basic information
Public title Non-inferiority test of a cereal-derived processed product on visceral fat area :a randomized, double-blind, non-inferiority crossover study
Acronym Non-inferiority test of a cereal-derived processed product on visceral fat area
Scientific Title Non-inferiority test of a cereal-derived processed product on visceral fat area :a randomized, double-blind, non-inferiority crossover study
Scientific Title:Acronym Non-inferiority test of a cereal-derived processed product on visceral fat area
Region
Japan

Condition
Condition healthy humans
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the non-inferiority between original product and development product on postprandial fat oxidation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fat oxidation amount of 60, 120, 180, 240 minutes later of test meal
Key secondary outcomes Energy expenditure, respiratory quotient and carbohydrate oxidation amount of 60, 120, 180, 240 minutes later of test meal

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of test food A (one time) -> washout (more than 5 days) -> intake of test food B (one time) -> washout (more than 5 days) -> intake of test food C
Interventions/Control_2 Intake of test food A (one time) -> washout (more than 5 days) -> intake of test food C (one time) -> washout (more than 5 days) -> intake of test food A
Interventions/Control_3 Intake of test food B (one time) -> washout (more than 5 days) -> intake of test food A (one time) -> washout (more than 5 days) -> intake of test food C
Interventions/Control_4 Intake of test food B (one time) -> washout (more than 5 days) -> intake of test food C (one time) -> washout (more than 5 days) -> intake of test food A
Interventions/Control_5 Intake of test food C (one time) -> washout (more than 5 days) -> intake of test food A (one time) -> washout (more than 5 days) -> intake of test food B
Interventions/Control_6 Intake of test food C (one time) -> washout (more than 5 days) -> intake of test food B (one time) -> washout (more than 5 days) -> intake of test food A
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. Age<65 of healthy men and menopause women
2. 23<=BMI<30
3. provided written informed consent from subjects
Key exclusion criteria 1; No participation of all examination,
2; liver, kidney and heart disease, or disorder of respiration endocrine, metabolism, nervous system consciousness, or diabetes, or other diseases,
3; LDL-cholesterol>=140mg/dL, triglyceride>=150mg/dL, Systolic blood pressure>=140mmHg, diastolic pressure>=90mmHg, fastinf bloodglucose>=126mg/dL,
4; given medication or operation by severe sickness and injuly within 2 months before the trial,
5; medicine user for hyperglycaemia, lipidemiia, or hypertension,
6; user of supplements or foods with health claim
7; unpleasant feeling during blood drawing
8; donated 200 mL or more blood within l month before the trial,
9; smoker,
10; having allergy to the ingredients included in the test meal,
11; shift worker,
12; business trip or travel planned for 6 consecutive days or more during this trial
13; cannot fill in record of daily diet for 9 days (3 days x 3 times) ,
14; cannot allow operator to consult his/her data of the past health check,
15; participating subject of other clinical study or having a plan during this study period,
16; disagree with explanation for study,
17; judged to be inappropriate as subject by physician in charge
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Noriko
Middle name
Last name Osaki
Organization Kao Corporation
Division name Health Care Food Research Labs
Zip code 131-8501
Address 2-1-3 Bunka Sumida-ku Tokyo
TEL 03-5630-7224
Email osaki.noriko@kao.co.jp

Public contact
Name of contact person
1st name Chizuka
Middle name
Last name Suzuki
Organization Kao Corporation
Division name Health Care Food Research Labs
Zip code 131-8501
Address 2-1-3 Bunka Sumida-ku Tokyo
TEL 03-5630-7456
Homepage URL
Email suzuki.chizuka@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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 Oriental Ueno medical center
Address 1-20-11 Ueno Taito-ku Tokyo
Tel 03-5816-0711
Email info@tes-h.co.jp

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 花王株式会社(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 20
Results
The 95% confidence interval of difference of fat oxidation between A-001 and B-001 or C-001 were exceeded non-inferiority margin.
Results date posted
2019 Year 08 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy subjects
Participant flow
20 participants completed and 20 subjects were incorporated into the analyses
Adverse events
No adverse effect related to the test diets reported
Outcome measures
Fat oxidation amount of 60, 120, 180, 240 minutes later of test meal
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 01 Month 19 Day
Date of IRB
2016 Year 01 Month 19 Day
Anticipated trial start date
2017 Year 01 Month 20 Day
Last follow-up date
2017 Year 02 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 19 Day
Last modified on
2019 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028884

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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