None
Conditions
Interventions
Ingestion of test food containing proteoglycan for 12 weeks
Ingestion of placebo food for 12 weeks
Sponsors
TTC Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females aged 40 and over (2) Subjects who have continuous low back discomfort for 3 months or more (3) Subjects who have habit of sleeping on bedding alone (4) Subjects with narrow values on low back range of motion
Exclusion criteria
Exclusion criteria: Subjects (1) who have low back pain due to pain in other joints (2) who are suspected gouty attack with hyperuricemia (3) who have positive rheumatoid factors on the screening test or may have rheumatic pain (4) who have performed arthroplasty on the low back or need it (5) who regularly take health food which may affect joints or muscles (6) who take medicine regularly (7) who have been performed nerve block injection within a year before the screening test or need to be done in the study period (8) who get an intense exercise to make excessive load on the body (9) who have a history of disorders affecting the evaluation of effectiveness such as fracture of the low back and acute low back pain within a year before the screening test (10) who regularly use a cane, a supporter of the low back or a corset (11) who periodically conduct actions that may affect the evaluation of effectiveness (12) who are under treatment of diseases that may affect the evaluation of effectiveness (13) who have severe diseases or have a history of such serious disorders (14) who are under treatment or have a history of mental diseases (15) who have unsteady lifestyle or who work manual labor (16) who drink a lot (17) who have possibilities for emerging allergy onset related to the study (18) who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (19) who have participated in other clinical study within a month before the screening test or who intend to participate in the study period (20) who are in a pregnancy or lactation period in the study period (21) who are judged as unsuitable due to lifestyle questionnaire (22) who regularly smoke (23) who are judged as unsuitable for the study by investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| JLEQ | — |
Secondary
| Measure | Time frame |
|---|---|
| QOL questionnaire Low back range of motion Trunk muscle strength | — |
Countries
Japan
Contacts
Public ContactTakashi Nakagawa
TTC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed