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Exploratory Study on the Effects of Ingestion of Lactobacillus Material on the Maintenance of Physical Condition

Exploratory Study on the Effects of Ingestion of Lactobacillus Material on the Maintenance of Physical Condition: Randomized, Double-blind, Placebo-controlled, Parallel Group Study - Exploratory Study on the Effects of Ingestion of Lactobacillus Material on the Maintenance of Physical Condition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056115
Enrollment
60
Registered
2024-11-12
Start date
2024-11-13
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

Healthy adult

Interventions

Sponsors

Hokkaido Information University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Those who agree to participate in this study with a written informed consent. 2.Healthy Japanese males and females between 35 and 59 years old at the time of the screening test. 3.Those prone to catching colds.

Exclusion criteria

Exclusion criteria: 1.Those with chronic diseases and use drug regularly. 2.Those have/ had diabetes, autoimmune disease, thyroid disease, adrenal disease. 3.Those with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring official reports. 4.Those with major surgical history related to the digestive system. 5.Those with seriously abnormal blood pressure, physical data or hematologic data. 6.Pregnant or lactating women or those planning to become pregnant. 7.Those who may have allergic reactions to drugs, foods or plants (esp. milk). 8.Those prone to diarrhea from dairy products. 9.Those who experienced discomfort during blood draw. 10.Those undergoing dental treatment or have dental/ oral issues involving bleeding at the time of the screening test, and whose symptoms are expected to continue throughout the study. 11.Pre- or post-menopausal women with obvious physical changes. 12.Those at risk of allergic reactions during the study. 13.Those who regularly taking health foods that affect this study at least 4 days per wk during the month prior to the screening test. 14.Those who regularly taking supplements at least 6 days per wk during the month prior to the screening test. 15.Those unable to stop taking foods claiming to maintain physical condition or immune function, yogurt, health foods, or supplements during the study. 16.Those have smoked within the past six mos. 17.Alcohol addicts. 18.Those with disordered lifestyle 19.Those planning to vaccination between the screening test and the final test. 20.Those planning to go abroad during the study. 21.Those who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks (both), or blood components within 2 wks (both), prior to the study. 22.Those participating or wish to participate in other clinical studies between 4 wks prior to the screening test and the final test. 23.Those ineligible due to physician's judgment.

Design outcomes

Primary

MeasureTime frame
Physical condition questionnaire

Secondary

MeasureTime frame
Immune function, QOL-related questionnaire

Countries

Japan

Contacts

Public ContactNaoyuki HONMA

Hokkaido Information University Health Information Science Center

hisc-acad.res@s.do-johodai.ac.jp011-385-4430

Outcome results

None listed

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