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

UMIN ID: UMIN000027569

Registered date:30/01/2018

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: 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).
• Date of first enrollment: 2017/05/26
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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
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
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
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

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Seiichiro Aoe Otsuma Womens University Faculty of Home Economics Department Food Science
• Source(s) of Monetary Support: Kellogg(Japan) G.K.