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The effect of continuous intake of test foods on immune markers and intestinal environment

The effect of continuous intake of test foods on immune markers and intestinal environment - The effect of continuous intake of test foods on immune markers and intestinal environment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044138
Enrollment
180
Registered
2022-04-27
Start date
2021-05-10
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 adults

Interventions

Intake of 2 tablets of test foods daily for 8 weeks. Intake of 2 tablets of placebo foods daily for 8 weeks.

Sponsors

Clinical Support Corporation, Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese males and females who aged 20 to under 65 at the time of informed consent. 2. Those who suffered from upper respiratory tract infection within the last two years 3. Those who are able to attend the examination site on the days of visit 4. Those who can make self-judgment to participate the study and are voluntarily giving written informed consent with signature and date

Exclusion criteria

Exclusion criteria: 1. Patients who have a medical history of liver disease, kidney disease, cardiac disease, organ disorder, diabetes, and other serious diseases 2. Patients who have a history of gastrointestinal resection (excluding appendectomy) 3. Those who have chronic medical diseases under treatment 4. Those who work during 22 to 5 o'clock as night shift worker 5. Those who are pregnant, wish to become pregnant during the test period, or are breastfeeding 6. Those who have excessive smoking habits or consume alcohol excessively 7. Those who cannot stop eating supplements or health foods including HOSHU and FFC which may activate immune functions 8. Those who have seasonal allergies during study period (July-September) or allergic rhinitis (seasonal or year-round) 9. Those who need to avoid consuming food whose origin is not clearly indicated due to religious or other reasons 10. Those who are judged as unsuitable for the study by the principal investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Major immune marker

Secondary

MeasureTime frame
Fecal examination, Blood metabolome, and Questionnaires to assess health condition

Countries

Japan

Contacts

Public ContactIsao Takehara

Clinical Support Corporation, Limited Food Service Division

takehara@csc-smo.co.jp011-223-3130

Outcome results

None listed

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