UMIN-CTR Clinical Trial

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

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Ingredion Japan K.K.

Institute

Department

Personal name

Organization

Ingredion Incorporated

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

KSO

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2018

Year

01

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2018

Year

01

Month

18

Day

Last modified on

2018

Year

07

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035247