Healthy subjects
Conditions
Interventions
Consumption of the test food to the subjects after breakfast, two drops a day for 12 weeks.
Consumption of the test food to the subjects after breakfast, two drops a day for 12 weeks.
Sponsors
IMEQRD CO., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects ranging in age from 40 to 69. (2) Subjects having chronic pain/discomfort on the knee since 6 months ago. (3) Subjects who gave informed consent to participate in this trial after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: Subjects with [] [1] some symptoms just like a muscular pain on a daily basis. [2] some kind of medical treatment. [3] diet/exercise therapies under the instruction of a medical doctor. [4] therapies at an orthopedic or a pain-clinic. [5] the grade II (and over) on a basis of KL (Kellgren-Lawrence) classification. [6] previous history of some kind of knee-treatment (e.g., artificial knee replacement), or any necessity to treat their knee joint. [7] a planning application of their knee-joint to some kind of drug-therapy. [8] injections of hyaluronic acid to their knee-joint within two weeks before the agreement for the trial, or steroid to their's within three months before the agreement. [9] previous history of diseases relating to the knee joint, such as a bone fracture, a sprain, etc. [10] health-specific/functional/health foods that might affect the test results. [11] the help of a stick on a daily basis. [12] not less than 30 kg/m2 BMI. [13] pregnancy, possible one, or lactation. [14] previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. [15] excessive alcohol intake. [16] extremely irregular life rhythms, midnight work or irregular shift work. [17] previous medical history of drug and/or food allergy. [18] the other clinical tests with some kind of medicines/foods, or taking part in those tests within four weeks after the current trial. [19] donation of over 200 mL of their whole blood and/or blood components within a month to the current trial. (20) Males who donated over 400 mL of their whole blood within the last three months to the current trial. (21) Females who donated over 400 mL of their whole blood within the last four months to the current trial. (22) Males who are going to be collected over 1200 mL within the last twelve months. (23) Females who are going to be collected over 800 mL within the last twelve months. (24) Others who have been determined as ineligible for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Visual Analog Scale (VAS)- questionnaire scores about some kind of knee-joint discomfort. 2. Japanese Knee Osteoarthritis Measure (JKOM)-questionnaire scores. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. EuroQOL 5 dimensions 5-level (EQ-5D-5L)-questionnaire scores about quality of life. 2. Activity of Daily Living (ADL)-test 3. Adverse events, and incidence rate of side effects | — |
Countries
Japan
Contacts
Public ContactMitsuhiro Fujimoto
CPCC Company Limited Planning & Sales Department
Outcome results
None listed