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Validation study for improvement of colon deterioration by BARLEYmax; Randomized double blind placebo control studies

Validation study for improvement of colon deterioration by BARLEYmax; Randomized double blind placebo control studies - Validation study for improvement of colon deterioration by BARLEYmax

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024031
Enrollment
30
Registered
2016-10-08
Start date
2016-09-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

People with tend to be colon deterioration

Interventions

Short bar incorporated in BARLEYmax(Amount of BARLEYmax intake:12g/day, Intake period:4 weeks) Short bar incorporated in wheat(Amount of BARLEYmax intake:0g/day,Intake period: 4 weeks)

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Defecation(2-4 times/week), 2.Meal times(3 times/day), 3.People with tend to be colon deterioration

Exclusion criteria

Exclusion criteria: 1.People who takes antiflatulent and laxative, 2.People who takes functional foods with constipation improvement function at the time of screening(including specified health foods, see Attachment 1), 3.People who takes antibacterial agents and gastrointestinal agents at the time of screening, 4. People who takes probiotics(lactobacillus, bifidobacteria, natto bacteria), food products incorporating oligosaccharide, dietary fibre, functional foods with constipation improvement function(including specified health foods, see Attach 1), and people who can not stop taking food products containing rich content of sugar alchol(see Attachment 2) and food products, supplement containing rich content of barley during test period, 5.People having food allergy, 6.People having disorder required emergency therapy and serious complicating disorder, 7.People having digestive disorder and surgical history, 8.People who is judged as inappropriate by questionnarie, 9.People who is judged as inappropriate by blood test at the time of screeing, 10.People who is pregnant, has pregnancy plan during test period, and is breast feeding, 11.People who has record of drug dependence, alchol dependence and current medical history, 12.People who takes other food products and has plan to join pharmaceutical testing, cosmetic testing and pharmaceuticl coating test, 13.People with treatment of special face care in the last three months(facial treatment, injection of hyaluronic acid, botox, chemical peeling, phototherapy, laser healing), 14.Others. People who is judged as inappropriate by responsible investigator

Design outcomes

Primary

MeasureTime frame
1.Defecation frequency, 2.Stool output

Secondary

MeasureTime frame
1.Amount of short chain fatty acid in stool, 2.Measurement of intestinal flora, 3.Analysis of expired gas, 4.Blood test(insulin, glucose, total cholesterol, LDL-cholesterol, neutral fat, free fatty acid), 5.Skin moisture, skin fitness, skin water loss, 6.Degree of colon deterioration

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026