UMIN-CTR Clinical Trial

Public title

Evaluation of a synergy effect on human intestinal condition with taking combination of wheat bran fiber and Barley Max in a randomized double blind study

Acronym

Effect of wheat bran fiber and Barley max on human intestinal condition.

Scientific Title

Evaluation of a synergy effect on human intestinal condition with taking combination of wheat bran fiber and Barley Max in a randomized double blind study

Scientific Title:Acronym

Effect of wheat bran fiber and Barley max on human intestinal condition.

Region

Japan

Condition

1.Defecation frequency: less than 5times/week
2.The people who have a low intake of fiber (lower than 12g/day by simple dietary record for 4 days (3 days in weekday and 1 day in weekend).

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To estimate the synergy efficiency the effect on the diversity of intestinal microbiota by taking both wheat bran and Barley Max.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Change of diversity index of bacteria in intestines by DNA analysis to genus in feces.
Timing of fecal sampling:0W/ 4W/ +2W

Key secondary outcomes

-Concentration of Short Chain Fatty Acid and organic acid in feces: Formic acid, acetic acid, propionic acid, isobutylate, butyric acid, valeric acid, iso valeric acid, lactic acid, succinic acid.
-Concentration of toxic component in feces: Indole, phenol, ammonia, scatole
-Lipopolysaccharide in serum (depends primary outcomes; only the case that bad bacteria increment is shown.)
Timing:Pre-health check/after 4w feeding
-Inquiry (Inquiry,Blood pressure,pulsation, Weight,Fat %)
-Analysis of urine (Urinary protein,sugar,urobilinogen)
-General blood check (leucocyte,erythrocyte,hemoglobin,Hematocrit,blood platelet,TP,ALB,T-Bil,AST(GOT),ALT(GPT),ALP,gamma-GTP,CPK,LDH,T-cho,TG,HDL-C,LDL-C,UA,BUN,CRE,Na,Cl,K,Ca,Blood sugar,HbAlc,Hbs Antigen quantitative(CLIA),HCV anti-body(3rd generation)
# of fecal sampling: 1 fecal sample/ period
Timing of fecal sampling: 0W/ 4W/ +2W

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Non Wheat bran nor Barley max: Key dietary fiber value is 9.2g /day with cellulose and wheat flour.
40g cereal bar x 2times / day substitute to staple food.
Feeding period; 4 weeks
Wash out period; 2 weeks before and after feeding period

Interventions/Control_2

Wheat bran fiber without Barley max:
Wheat bran fiber 5.7g, cellulose 3.2g wheat flour 0.3g as fiber.,
Key dietary fiber is 9.2g with wheat bran fiber and cellulose.
40g cereal bar x 2times / day substitute to staple food.
Feeding period; 4 weeks
Wash out period; 2 weeks before and after feeding period

Interventions/Control_3

Barley max without wheat bran fiber:
Cellulose fiber 5.4g and fiber from wheat flour (0.3g).
Fiber from Barley max 3.5g using Barley max powder 12g. (assume this is the efficacious dose of BarleyMax)
Key dietary fiber is 9.2g with cellulose, wheat flour and fiber from Barley Max.
40g cereal bar x 2times / day substitute to staple food
Wash out period; 2 weeks before and after feeding period

Interventions/Control_4

Wheat bran fiber and Barley max: Wheat bran fiber 5.7g (using 19g wheat bran powder) and Fiber from Barley max 3.5g using Barley max powder 12g.
Key dietary fiber is 9.2g with wheat bran fiber and Barley max
40g cereal bar x 2times / day substitute to staple food.
Feeding period; 4 weeks
Wash out period; 2 weeks before and after feeding period

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

Basically healthy person
1.Defecation frequency: less than 5times/week
and
2.The people who intakes low amount of fiber (lower than 12g/day)

Key exclusion criteria

Same as Jpn Pharmacol Ther.44,1785 (2016)
1.The person who uses a medicine for intestinal disorders and aperient (including the laxative) regularly
2.The person who uses health foods told to be good for constipation improvement at the time of screening examination (including the food for specified health use) regularly
3.The person who takes a drug affecting the digestion and absorption including the antibiotic at the time of screening examination
4.The person who cannot stop raw fungal inclusions such as a lactic acid bacterium, a bifidus bacillus, the Bacillus natto, the food which strengthened an oligosaccharide, a dietary fiber, a health food (including the food for specified health use) said to that it is good for constipation improvement and sugar alcohol large quantity component food, the barley-rich food, the intake of the supplement all over the study time
5.Person having food allergy
6.A person infected with a disease to urgently need treatment or person having serious complications
7.Person with a history of a digestive organ disease to affect the digestion and absorption and the bowel movement or the operation
8. It was judged the answer to subject background questionnaire to be inappropriate as a subject (the plan that greatly changes includes life events all over the study time)
9. Person whom it was judged a blood test with the screening examination to be inappropriate as a subject. E.g. Person who have some kind of diseases.
10. Pregnant person, person with the intention of the pregnancy during the study time, the person whom I am nursing
11. Person with drug dependency, an anamnesis of alcohol dependence or the existing medical history
12. Person participating in an examination to apply an intake of other food and the examination using the drug, cosmetics and a drug, person with the intention of the participation
13. Others. the person who judged an examination responsibility doctor to be inappropriate as a subject

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Seiichiro Aoe

Organization

Otsuma Womens University

Division name

Fuculty of Home Economics

Zip code

Address

12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan

TEL

+81-3-5275-6048

Email

s-aoe@otsuma.c.jp

Name of contact person

1st name
Middle name
Last name	Seiichiro Aoe

Organization

Otsuma Womens University

Division name

Fuculty of Home Economics

Zip code

Address

12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan

TEL

+81-3-5275-6048

Homepage URL

Email

s-aoe@otsuma.c.jp

Institute

Seiichiro Aoe
Otsuma Womens University
Faculty of Home Economics
Department Food Science

Institute

Department

Personal name

Organization

Kellogg(Japan) G.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

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

大妻女子大学（東京都）/Otsuma Women’s university (Tokyo)
CPCC株式会社/CPCC Company Limited

Date of disclosure of the study information

2018

Year

01

Month

30

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6316639/

Number of participants that the trial has enrolled

Results

In the present study, we investigated which of these two fiber sources would produce more favorable changes in the fecal variables of healthy subjects. Sixty healthy subjects were randomly divided into four groups (n = 15 per group) and fed twice daily for 4 weeks with baked cereal bars containing neither WB nor BM (WB-BM-), WB without BM (WB+BM-), BM without WB (WB-BM+), or WB and BM (WB+BM+). At baseline and after 4 weeks, the fecal microbiota composition and the concentrations of short-chain fatty acids were measured. A significant interactive effect of WB and BM on the abundance of genus Bacteroides was observed at week 4. The abundance of butyrate-producing bacteria and the fecal concentration of n-butyrate were significantly higher in the WB+ groups than in the WB- groups. In conclusion, WB was associated with elevated fecal concentrations of short-chain fatty acids including butyrate owing to an increase in the abundance of butyrate-producing bacteria. Additionally, the combination of WB and BM was associated with an increase in the abundance of genus Bacteroides. Therefore, both WB alone and WB combined with BM favorably influenced the fecal variables of healthy subjects.

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

05

Month

18

Day

Date of IRB

Anticipated trial start date

2017

Year

05

Month

26

Day

Last follow-up date

2017

Year

10

Month

10

Day

Date of closure to data entry

2017

Year

10

Month

13

Day

Date trial data considered complete

2017

Year

10

Month

13

Day

Date analysis concluded

2017

Year

12

Month

15

Day

Other related information

Registered date

2017

Year

05

Month

31

Day

Last modified on

2019

Year

03

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031607