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Effects of consumption of the test food on the physical condition and the immune function of healthy subjects

Effects of consumption of the test food on the physical condition and the immune function of healthy subjects: A randomized, double-blind, placebo-controlled, parallel-group comparison trial - Effects of consumption of the test food on the physical condition and the immune function of healthy subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042291
Enrollment
60
Registered
2021-07-31
Start date
2020-10-30
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

Duration: Eight weeks Test food: Active food Administration: Take two packs per day (one pack each after breakfast and dinner with half a glass of water). *If you forget to take the test food, ta

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adult subjects 2. Subjects who are easy to get tired and sick 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who have relatively high scoring of FI at screening

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.Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4.Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5.Subjects who eat foods highly containing lactic acid bacteria such as lactic acid bacteria beverages and fermented foods more than two days per week 6.Subjects who eat foods highly containing collagen and/or gelatin such as beef sinew, liver, offal (motsu or horumon), pig's feet, chicken leg, chicken wing, chicken skin, chicken gristle (nankotsu), fish skin, conger pike (hamo), eel, anglerfish, jellied broth (nikogori), collagen-nabe, gelatin, gummi, and marshmallow more than two days per week 7.Subjects who are currently taking medications (including herbal medicines) and supplements 8.Subjects who are allergic to medicines and/or the test food-related products. Particularly allergic to fish, collagen, and gelatin. 9.Subjects who have a pollen allergy 10.Subjects who have received vaccination for infectious diseases such as influenza within a year before the agreement to participate in this trial 11.Subjects who are smokers, or started smoking cessation within a year before the agreement to participate in this trial 12.Subjects who are pregnant, lactating, or planning to become pregnant 13.Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 14.Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

MeasureTime frame
The Questionnaire concerning the physical condition

Secondary

MeasureTime frame
1. The Questionnaire concerning the physical condition (Items excluding the primary outcome) 2. Immune functions 3. Diary questionnaires

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