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Effects of consumption of structured lipid on the oral environment in healthy Japanese subjects

Effects of consumption of structured lipid on the oral environment in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of structured lipid on the oral environment in healthy Japanese subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052398
Enrollment
60
Registered
2023-10-04
Start date
2023-10-04
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

Healthy Japanese subjects

Interventions

Test food: Structured lipid Administration: 4.76 g/day Duration: 12 weeks Test food: Corn oil Administration: 4.76 g/day Duration: 12 weeks

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Yuseikai, Horiuchi Dental Clinic Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 45 or more 4. Healthy subjects 5. Subjects with 20 or more natural teeth 6. Subjects who have mild periodontal disease

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" 5. Subjects who are taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products (particularly fish or gelatin) 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are judged as ineligible to participate in this study by the physician 10. Subjects who use artificial tooth, post crowns, dentures, implants or bridges 11. Subjects who use floss, interdental brushes, and mouthwash at brushing their teeth 12. Subjects who have undergone dental maintenance such as plaque and tartar removal at a dental clinic within the last 3 months before obtaining consent, or who are planning to undergo maintenance during this trial 13. Subjects who regularly use gargle medicine 14. Subjects with past or present history related to salivary gland disease (such as sialadenitis, sialolithiasis, Sjogren syndrome, or tumor of salivary gland), or who have undergone salivary gland removal 15. Subjects undergoing treatment for dental disease 16. Subjects who are smokers, or started smoking cessation within one year before the agreement to participate in this trial

Design outcomes

Primary

MeasureTime frame
Assessment items for periodontal disease

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