UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000024510
Receipt No. R000028166
Scientific Title Effect of cereal-derived processed product on metabolism :a randomized, double-blind, crossover study
Date of disclosure of the study information 2016/10/24
Last modified on 2019/08/26 (Ver. 5)

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Basic information
Public title Effect of cereal-derived processed product on metabolism :a randomized, double-blind, crossover study
Acronym Effect of cereal-derived processed product on metabolism
Scientific Title Effect of cereal-derived processed product on metabolism :a randomized, double-blind, crossover study
Scientific Title:Acronym Effect of cereal-derived processed product on metabolism
Region
Japan

Condition
Condition healthy humans
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of cereal-derived processed product on metabolism, and clarify its mechanism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fat oxidation
Key secondary outcomes Serum glucose-dependent insulinotropic polypeptide and insulin.
Energy expenditure

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 Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of control food (one time)
Interventions/Control_2 Intake of test food (one time)
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
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; suffering from liver, kidney, heart disease, disorder respiration endocrine, metabolism, nervous system consciousness, diabetes, or other diseases
2; LDL-cholesterol>=140mg/dL, triglyceride>=150mg/dL, Systolic blood pressure>=140mmHg, diastolic pressure>=90mmHg, fasting blood glucose>=126mg/dL,
3; taking medication or operation by severe sickness and injury within 2 months before the trial,
4; becoming unpleasant feeling after blood test or energy expenditure analyzing (metabolic chamber, collecting of breath by mask or hood)
5; making blood donation of 200 mL or more within l month of this trial
6; medicine user for hyperglycemia, hyperlipidemia, or hypertension,
7; unstable measurement of energy expenditure
8; heavy drinker(more than 30 g/day alcohol everyday)
9; user of supplements or foods with health claim
10; having variability in body weight more than +-2.0 kg within 1 month of this trial
11; business trip or travel planned for 5 consecutive days or more during this trial
12; having allergy to gum
13; having allergy to the ingredients included in the test meal
14; smoker
15; participating subject of other clinical study or having a plan during this study period,
16; judged to be inappropriate for the study based on the access record by medical doctor.
17; judged to be inappropriate as subject by physician in charge

Target sample size 15

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.co.jp

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 Kao Corporation Human Research IRB
Address 2-1-3 Bunka Sumida-ku Tokyo
Tel +81-3-5630-7263
Email morisaki.naoko@kao.com

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
2016 Year 10 Month 24 Day

Related information
URL releasing protocol Unpublished due to the protocol including the intellectual property rights
Publication of results Published

Result
URL related to results and publications works in progress
Number of participants that the trial has enrolled 22
Results 
Significant difference in the primary outcome
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 
21 participants completed and 21 subjects were incorporated into the analyses
Adverse events 
No adverse effect related to the test diets reported
Outcome measures 
Postprandial fat oxidation
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 10 Month 12 Day
Date of IRB
2016 Year 10 Month 24 Day
Anticipated trial start date
2016 Year 10 Month 24 Day
Last follow-up date
2016 Year 12 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 21 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=R000028166