UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Effect of wheat bran fiber and Barley max on human intestinal condition.
Region	Japan

Condition
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

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Seiichiro Aoe
Organization	Otsuma Womens University
Division name	Fuculty of Home Economics
Address	12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
TEL	+81-3-5275-6048
Email	s-aoe@otsuma.c.jp

Public contact
Name of contact person	Seiichiro Aoe
Organization	Otsuma Womens University
Division name	Fuculty of Home Economics
Address	12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
TEL	+81-3-5275-6048
Homepage URL
Email	s-aoe@otsuma.c.jp

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

Funding Source
Organization	Kellogg(Japan) G.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6316639/
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.
Other related information

Management information
Registered date	2017 Year 05 Month 31 Day
Last modified on	2019 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031607