Randomized, controlled, double-blind intervention study of four parallel branches depending on the product consumed, to analyze the efficacy of an Omega-3 based product on the mobility and functionality of the evaluated joint.
The duration of the study will be 60 days (8 weeks). Each day they will have to consume the product under investigation. Subjects who meet the selection criteria will be randomized into each of the study groups (A, B, C o D, depending on the group in which they have been randomized). Each day the subjects will have to fill in a diary regarding pain and concomitant medication. They will make a total of two visits to the research laboratory and will perform the tests pre-established in the protocol. In addition, a follow-up telephone call will be made after 30 days of consume. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
130
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Product with identical characteristics to the experimental product. Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
Catholic University of Murcia
Murcia, Spain
Change in Pain from baseline at 8 weeks
Visual analog scale from 0 to 10. The higher the value, the more pain.
Time frame: The evolution of pain after consumption during 8 weeks will be measured.
Quality of life test: WOMAC test
The quality of life of the subjects will be measured with the WOMAC test. It is a 24-item test that will measure the degree of pain: nothing, little, enough and a lot, when performing activities in daily life.
Time frame: Change in initial quality of life at 8 weeks.
Change in Pain from baseline at 8 weeks
Visual analog scale from 0 to 10. The higher the value, the more pain.
Time frame: Pain will be measured with a daily scale, from baseline to 8 weeks.
Functional test
The balance and mobility of the subjects will be measured with the Timed Up and Go Test
Time frame: The test will be measured at baseline and after 8 weeks of consumption.
Muscle function
Isokinetic and isometric dynamometry
Time frame: The test will be measured at baseline and after 8 weeks of consumption.
Change in concomitant analgesic medication
The change in the need for the use of analgesic medications will be evaluated
Time frame: The test will be measured at baseline and after 8 weeks of consumption. It will also be evaluated on a daily basis
Sleep efficiency
Measured by accelerometry, with Actigraph wGT3X-BT
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Time frame: The test will be measured at baseline and after 8 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
Sleep quality
Measured by Pittsburgh test
Time frame: It will be measured twice, once at baseline or at the end of the study after 8 weeks of use
Omega-3 Bioavailability
Measured by omega quant
Time frame: It will be measured twice, once at baseline or at the end of the study after 8 weeks.
Liver safety variables
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
Time frame: It will be measured twice, once at baseline or at the end of the study after 8 weeks.
Physical activity
It is a control variable. Measured by accelerometry, with Actigraph wGT3X-BT
Time frame: The test will be measured at baseline and after 8 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
Physical activity control
It is a control variable. Measured by fitbit
Time frame: The test will be measured at baseline and after 8 weeks of consumption.
Body composition
It is a control variable. Measured by bioimpedance
Time frame: The test will be measured at baseline and after 8 weeks of consumption.
Waist - hip circumference
It is a control variable.
Time frame: The test will be measured at baseline and after 8 weeks of consumption.