None listed
Conditions
Interventions
Dietary Supplement : Test Food:
- Krill Oil Compound (Flexpro MD)
- Once daily, 1 capsule per dose, consumed for 12 weeks (providing 462mg/day of krill oil compound)
Control Food:
- Placebo
- Consume
Sponsors
Novarex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged between 30 and under 75 years. 2) Individuals with a Visual Analogue Scale (VAS) score of 30mm or higher. 3) Individuals with Kellgren & Lawrence grading scale grade I or II for the knee joint or hip joint, as determined by X-ray. 4) Individuals who have agreed to participate in this human clinical trial and have signed the informed consent form before the start of the trial.
Exclusion criteria
Exclusion criteria: 1) Individuals with arthritis caused by factors other than degeneration, as judged by the participant. 2) Individuals with joint spacing of 2mm or less. 3) Individuals with moderate arthritis characterized by concurrent factors such as bone cysts around the joint, irregular joint surfaces, and cartilage subchondral cysts, among others, resulting in joint deterioration. 4) Individuals with clinically significant cardiovascular, immune, infectious, or neoplastic diseases other than joint pain. 5) Individuals currently undergoing treatment for gastritis or gastric ulcers (registration possible if not currently undergoing treatment). 6) Participants with uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg, measured after 10 minutes of rest). 7) Participants with uncontrolled diabetes (fasting blood glucose =180 mg/dL or starting antidiabetic medication within the last 3 months). 8) Individuals with thyroid disorders, with TSH levels below 0.1 µU/mL or above 10 µU/mL. 9) Individuals with AST (GOT) or ALT (GPT) levels exceeding three times the normal range at the testing institution. 10) Individuals with creatinine levels exceeding two times the normal range at the testing institution. 11) Pregnant, breastfeeding, or planning pregnancy within the next 3 months. 12) Participants who have consumed arthritis-related medications or health functional foods aimed at joint health within the past 2 weeks of screening. 13) Individuals with psychiatric disorders such as schizophrenia, depression, or substance abuse. 14) Individuals who have received physical therapy or alternative treatments (acupuncture, moxibustion, cupping therapy, etc.) for degenerative arthritis within 2 weeks prior to screening. 15) Individuals who have participated in another clinical trial within 2 months before the start of the current trial or plan to participate in another trial during the course of the current trial. 16) Individuals sensitive to or allergic to ingredients related to the test food for the human clinical trial. 17) Individuals judged by the participant to be unsuitable for the current human clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS) after 12 weeks of consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS after 6 weeks of consumption;Total score and individual scores of K-WOMAC;KSF-36;Investigator's assessment of improvement;Participant's assessment of improvement;CTX-? (Urine), CRP (Serum);Adverse reactions;Clinical laboratory tests (hematological/biochemical tests, urine analysis);Vital signs (heart rate, blood pressure), anthropometric measurements (weight);Electrocardiogram (ECG) | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung-Baik Kang
Seoul National University
Outcome results
None listed