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A randomized, parallel-group comparison study on the effects of continuous intake of barley on human immune function and others

A randomized, parallel-group comparison study o on the effects of continuous intake of barley on human immune function and others - A study on the effects of continuous intake of barley on human immune function and others

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049817
Enrollment
60
Registered
2024-12-31
Start date
2022-12-15
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

Healthy subjects

Interventions

100 g/day of boiled barley intake for 8 weeks 100 g/day of cooked white rice intake for 8 weeks

Sponsors

National Agriculture and Food Research Organization
Lead Sponsor
Faculty of Medicine, University of Tsukuba
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Japanese men and women aged 20 years or older at the time of registration. 2.BMI not less than 18.5 kg/m2, under 25.0 kg/m2 3.Those who do not have any disease receiving continuous treatment, medication, and lifestyle guidance. 4.Those who usually consume cooked white rice as a staple food at least once a day (Priority given to registrate those who consume at least 100 g/meal of cooked white rice). 5.Those who can input their own data into the electronic diary. 6.Those who do not plan to be vaccinated against COVID-19 during the research period. 7.Those who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.

Exclusion criteria

Exclusion criteria: 1.Those who are receiving any types of medicines and/or Chinese medical treatment except a dose of medicine taken only once. 2.Those who have medical treatments such a diet therapy and/or an exercise therapy. 3.Those who had been experiencing a severe disease. 4.Those who currently have or have history of allergic dermatitis, allergic rhinitis (including seasonal hay fever), bronchial asthma, and chronic bronchitis. 5.Those who have a drug/food allergy. 6.Those who have currently been taking commercially available drugs, quasi-drug products, and foods or supplements with functional claims. However, those who can discontinue taking these foods during the trial period after obtaining informed consent will be allowed to join the trial. 7.Those who have currently been taking rice other than white rice (e.g. brown rice, barley rice, mixed grain rice) as a staple food. 8.Those who have currently been taking barley products. 9.Those who drink more than 60 g alcohol/day. 10.Those who have excessive smoking habits (21 or more cigarettes/day). 11.Those who frequently have to redo of blood for medical examinations, and who have felt unwell due to blood collection in the past. 12.Those who have donated blood of 200 mL or more by blood component donation or whole blood donation within 1 month before the beginning of the study. 13.Those who work on the shiftwork. 14.Those who have plans of major change on their lifestyle (e.g. diet, sleep and exercise) during the study period. 15.Those who are planning to travel abroad during the study period. 16.Those who have joined other clinical trials in the past 1 month before receiving informed consent in this study, or are currently joining other clinical trials, or are planning to join other clinical trials. 17.Women who are pregnant or may become pregnant, or lactating. 18.Those who are unsuitable for this trial that judged by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Questionnaire for physical condition and stress

Secondary

MeasureTime frame
1.Expression levels of CD86 and others in conventional DC,plasmacytoid DC, and monocyte 2.NK cell activity 3.White blood cell count 4.Levels of IgA in feces 5.Levels of short chain fatty acids in feces 6.Intestinal flora

Countries

Japan

Contacts

Public ContactMasuko Kobori

National Agriculture and Food Research Organization Institute of Food Research

kobori@affrc.go.jp029-838-7970

Outcome results

None listed

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