UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030873
Receipt No. R000035247
Scientific Title Energy value confirmation study of the dietary fiber material using breath measurement
Date of disclosure of the study information 2018/01/18
Last modified on 2018/07/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Energy value confirmation study of the dietary fiber material using breath measurement
Acronym Energy value confirmation study of the dietary fiber material using breath measurement
Scientific Title Energy value confirmation study of the dietary fiber material using breath measurement
Scientific Title:Acronym Energy value confirmation study of the dietary fiber material using breath measurement
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to confirm that hydrogen gas is not contained in the breath after ingesting high cross-linked tapioca resistant starch and high cross-linked potato resistant starch to make evidential documents that support the proposition that both resistant starch are not assimilated by enterbacteria in the lumen of the gastrointestinal tract and do not become energy for humans.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change over time of the breath hydrogen
Cmax of the breath hydrogen, AUC
Key secondary outcomes Interview, blood pressure/ pulse rate, subjective and objective symptom, adverse events

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 High cross-linked tapioca resistant starch
5g of resistant starch, single intake
Interventions/Control_2 high cross-linked potato resistant starch
5g of resistant starch, single intake
Interventions/Control_3 Fruct-oligosaccharide
5g of FOS, single intake
Interventions/Control_4 150 mL of water, single intake
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
40 years-old >
Gender Male and Female
Key inclusion criteria (1) Those whose BMI is 18 or more and less than 25
(2) Normal Blood sugar value
(3) Those who are informed to the fullest extent about the purposes and contents of the study, have the ability to give consent, volunteer for participation after having fully understood, and agree to participate in the study writing.
Key exclusion criteria (1)Those who have relatives within the fourth degree with diabetes
(2)Those who have extremely high methane in the breath or those have little hydrogen as a result of the breath test of the screening test
(3)Those who cannot quit ingesting foods with high hydrogen discharge, such as yogurt or sugar alcohol, and foods enhanced with oligosaccharides and dietary fiber during the study (see Attachments 1 and 2)
(4)Those who have chronic disease and regularly use medicines
(5)Those who regularly consume excessive alcohol and tobacco
(6)Those who have disease that is considered to affect gastric emptying
(7)Those who have heavy constipation
(8)Those who have gastrointestinal disease affecting digestion and absorption and who have a surgical history of the digestive organs
(9)Those with a diagnosis of IBS (irritable bowel syndrome)
(10)Those who have a disease such as upper respiratory inflammation and acute gastroenteritis
(11)Those who were determined unsuitable as subjects from the blood test conducted for the screening test
(12)Those who provided sampling blood or donated ingredient blood that was more than 200 mL within one month preceding the date of informed consent or more than 400 mL within three months preceding the date of informed consent
(13)Those who have a past medical history or a current medical history of drug dependence or alcohol dependence
(14)Those who are participating in or are willing to participate in the study in which other foods are ingested or medicines are used or the study applying cosmetics and medicines
(15)Those who are pregnant, those who intend to become pregnant during the study, those who are breastfeeding
(16)In addition, those who were determined to be inappropriate as subjects by the investigator
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kenichi Matsushima
Organization Ingredion Japan K.K.
Division name Food Technical Service
Zip code
Address 3-5-10, Shimbashi, Minato-ku, Tokyo, Japan
TEL (03)3504-9914
Email kenichi.matsushima@ingredion.com

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Matsushima
Organization Ingredion Japan K.K.
Division name Food Technical Service
Zip code
Address 3-5-10, Shimbashi, Mitato-ku, Tokyo, Japan
TEL (03)3504-9914
Homepage URL
Email knenichi.matsushima@ingredion.com

Sponsor
Institute Ingredion Japan K.K.
Institute
Department

Funding Source
Organization Ingredion Incorporated
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor KSO
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 一般財団法人船員保険会 品川シーズンテラス検診クリニック(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 18 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
Analysis of variance using GLM was performed for the AUC of the hydrogen in the exhaled air with the period, order, and test food materials as fixed factors and the subjects as the variable factor. As a result, there were no significant differences in the AUC of the hydrogen in the exhaled air with regard to the effects of period and order, and no carryover effect was observed. Therefore, the crossover study was considered valid.
Hydrogen in the exhaled air was significantly lower than the control food material intake period for the test food material 1 intake period and test food material 2 intake period at 2, 3, 4, 5, 6, 7, 8, and 9 hours after intake. Also, the level in the negative control intake period was significantly lower than the control food material intake period at 2, 3, 4, 5, 6, 7, 8, 9, and 11 hours after intake.
AUC and Cmax of the hydrogen level in the exhaled air were significantly lower than the control food material intake period for the test food material 1 intake period, test food material 2 intake period, and negative control intake period.No serious adverse events occurred during the study period. 
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
2017 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 19 Day
Last follow-up date
2018 Year 01 Month 30 Day
Date of closure to data entry
2018 Year 03 Month 02 Day
Date trial data considered complete
2018 Year 03 Month 16 Day
Date analysis concluded
2018 Year 04 Month 13 Day

Other
Other related information The safety of the cross-linked tapioca resistant starch and cross-linked potato resistant starch was confirmed. The hydrogen levels in the expired air following the intake of cross-linked tapioca resistant starch and cross-linked potato resistant starch were similar to the behavior after the intake of negative control, suggesting that both of these resistant starches were not utilized by intestinal bacterial after entering the digestive tract and were therefore not used as energy by humans.

Management information
Registered date
2018 Year 01 Month 18 Day
Last modified on
2018 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035247

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.