healthy subjects
Conditions
Interventions
plant tuber extract 210 mg, 8weeks
Placebo, 8weeks
Sponsors
IMEQRD Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who aged more than 40 years, less than 75 years. (at the time of submission of an informed consent) 2) Healthy subjects (who were judged as healthy individuals by the principal investigator) 3) Men and women 4) Subjects who have a discomfort in the knee joints of both feet or one foot. 5) Subjects whose question I in the JKOM questionnaire is more than 20 mm. 6) Subjects who can use smartphone.(who can use electronic diaries) 7) Subjects who do not intend to change or do not change everyday lifestyle habits during the study period. 8) Subjects who can continue to take test food for 8 weeks. 9) Subjects who can provide their written informed consent.
Exclusion criteria
Exclusion criteria: 1) Currently in treatment with medical products. 2) Currently under exercise and diet treatment. 3) Currently visiting hospital for treatment of knee pain. 4) More than 2 of KL (Kellgren-Lawrence) classification grade. 5) Diagnosed with hyperuricemia and the possible occurrence of an attack of gout. 6) Diagnosed with severe disorders such as diabetes, a circulatory disease, a hepatic disease, a renal disease and a cardiac disease, or previous history. 7) Positive at rheumatoid factor, or may cause pain from rheumatism. 8) Undergone or need knee surgery. 9) Need for pharmacological articular treatments during the study. 10) Undergone a hyaluronic acid injection within two weeks before the selection or a steroid injection within three months before the selection. 11) Diagnosed with bone or joint-related diseases such as a fracture and a sprain within the past three months. 12) Regular intake of health food that contains hyaluronic acid, glucosamine, chondroitin sulfuric acid, quercetin glycoside, vitamin D, or an amino-acid drug, or have the intention of consuming the health food during the study. 13) Regular intake of a medical products with an influence on the evaluation of the study (particularly, a medical products that contains glucosamine, chondroitin sulfuric acid, vitamin D or an amino-acid drug, or a medical products for the treatment of osteoporosis). 14) Excessive alcohol (over 60 g per day) intake. 15) Regular use of a cane. 16) Medical history of drug or food allergy. 17) Having the potential to become pregnant during the study or currently pregnant (including a possibility of being pregnant) or nursing. 18) Currently or history of drug abuse. 19) More than 30 kg / m2 of BMI. 20) Participated in other clinical trials within a month from the date of obtaining consent, or during the study. 21) Matched with exclusion criteria, since submission of an informed consent. 22) Unsuitable for enrollment in the opinion of the principal or sub investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Japanese Knee Osteoarthritis Measure (JKOM) | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaire The 25-question geriatric locomotive function scale Assess high sensitivity C-reactive protein Hematologic test, Blood biochemical test Urine analysis Adverse events Number of occurrences of side effects Height, weight, BMI, blood pressure, pulse rate Other associated symptoms | — |
Countries
Japan
Contacts
Public ContactMarie Kosehira
Omnica Co.,Ltd Research Dept.
Outcome results
None listed