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A verification study on improvements in the immune system and defecation: A randomized open trial

A verification study on improvements in the immune system and defecation: A randomized open trial - A verification study on improvements in the immune system and defecation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026387
Enrollment
60
Registered
2017-03-03
Start date
2017-03-04
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

Japanese adults who are healthy or regularly see a doctor

Interventions

Duration: 4 weeks Test Material: Nutrient-rich liquid food Dosage: Drink 1 pack (125 mL) for a day before breakfast Duration: 4 weeks Test Material: Orange juice Dosage: Drink 1 pack (125 mL) fo

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese adults, who is 65 years and more, are aware of daily fatigue 2. Priority selection is made in the order of II: warning zone, III: observation zone, and IV: safety zone, in immunological grade at baseline *However, V (sufficiently high) and I (critical zone) are excluded

Exclusion criteria

Exclusion criteria: 1. Those who have the medical history or under the treatment of malignant tumor 2. Those who have the medical history or under the treatment of autoimmune disease 3. Those who have the medical history or under the treatment of inflammatory bowel disease 4. Those who are currently hospitalized 5. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 6. Those who eat Natto, yogurt, and food and beverage including lactic acid bacteria in daily 7. Those who are smokers 8. Those who take anti-allergic drugs 9. Currently taking supplements 10. Those who are allergic to medicines and/or the test food related products 11. Those who are pregnant, breast-feeding, and plan to become a pregnant 12. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 13. Others considered as inappropriate for the study by the physician

Design outcomes

Primary

MeasureTime frame
1. Scoring of immunological vigor *Assess at 0 and 4 weeks after consuming

Secondary

MeasureTime frame
1. Immunity test T lymphocyte age, Immunological age, T cells, CD4+T cells / CD8+T cells ratio, naive T cells, naive T cells / memory T cells ratio, B cells, NK cells, CD8+CD28+T cells, T-cell proliferation index, CD4+T cells, CD8+T cells, memory T cells *Assess at 0 and 4 weeks after consuming 2. Subjective symptoms a. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) b. Bristol Stool Scale c. Bowel movement diary d. The Likert scale method *Above a, b, and d, assess at 0 and 4 weeks after consuming *Above c, record when defecating 3. Saliva test Salivary immunoglobulin A (sIgA) *Assess at 0 and 4 weeks after consuming 4. Blood test High-sensitive CRP, albumin, prealbumin *Assess at 0 and 4 weeks after consuming 5. Physical examination Muscle mass, grip strength *Assess at 0 and 4 weeks after consuming

Countries

Japan

Contacts

Public ContactNaoko SUZUKI

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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