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Bone & Joint Health Clinical Trials

Scientific Background

Bone and joint health are critically important to overall health and quality of life. The bony skeleton serves both a structural function, providing mobility, support and protection for the body, and a reservoir function, as a storehouse for essential minerals. Joints, the location where two or more bones or any rigid parts of the skeleton connect with each other, form a mechanical support to the skeleton and allow a variety of movements in different ranges between the rigid skeletal elements. Several factors contribute to the maintenance of skeletal health including gender, age, body size (weight and height), race and genetics which cannot be altered and other modifiable factors such as hormonal status, lifestyle (nutrition, smoking, alcohol consumption, physical activity) and perhaps the microbiome?

The human skeleton is a dynamic organ; it is continually undergoing renewal through a cycle of bone resorption and formation know as bone remodelling. Bone cells play a crucial role in maintaining a balance between resorption (osteoclasts) and formation (osteoblasts) during bone remodelling. When this balance is disrupted, bone diseases such as osteoporosis may result. Osteoporosis is a silent and asymptomatic disease characterised by a systemic impairment of bone mass and microarchitecture that results in fragility fractures. With an ageing population, the medical and socioeconomic effect of osteoporosis will continue to increase.

In conjunction with, or as an alternative to, traditional pharmacotherapies, there is an urgent need to develop and implement affordable nutritional approaches (including functional foods) for the prevention, treatment and managements of bone and joint disease such as osteoporosis and osteoarthritis (a painful and degenerative joint disease). For example, at present there is a wide range of nutraceuticals including bioactive peptides which show promising results for management of osteoporosis. However, their dosage regimen, safety and efficacy need to be evaluated in well-designed and in-depth clinical trials.

What Atlantia offer

Atlantia Food Clinical Trials has extensive experience in conducting human dietary intervention studies across a variety of health areas including those related to bone and joint health such as sarcopenia, osteopenia, arthritis, etc.

We have conducted trials on a variety of investigational food products (IP), ranging from probiotics, prebiotics, fibers and a range of other substrates, including botanical extracts, minerals, vitamins, peptides and short chain fatty acids (SCFA).

We have a large database of healthy subjects striated across gender and age, and also a considerable patient database.

Our expert research team will work with sponsor(s) to design and conduct a study most suitable for their IP, agreeing and applying the most suitable diagnostics. We can statistically power your study to ensure that your objectives are achieved and reported in accordance with EFSA  and FDA guidelines.

Measurements & Indications

Bone & Joint Health Assessment (OBJECTIVE)
Physical performance & functional capacity: hand grip strength (sarcopenia), knee extension & flexion measured by goniometry
Bone mass and bone mineral density (BMD) using dual-emission X-ray absorptiometry (DEXA); osteoarthritis: X-RAY & Kellgren-Lawrence Gradient Scale
Inflammatory markers: interleukins (IL) -1B1, erythrocyte sedimentation rate (ESR), hsCRP, serum osteocalcin, serum hyaluronic acid (HA), serum keratin sulphate, transforming growth factor beta (TGF-B)
Bone & Joint Health Assessment (SUBJECTIVE)
Osteoarthritis: Western Ontario & McMaster Universities Arthritis Index (WOMAC) to assess joint pain, stiffness & physical function; Knee Injury and Osteoarthritis Outcome Score (KOOS): to assess pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life following knee injury
Pain Intensity: Visual Analogue Scale (VAS); Numeric Rating Scale (NRS); Verbal Descriptive Scale (VDS); McGill Pain Questionnaire
Physical Performance & functional capacity: Short Physical Performance Battery (SPPB) assessing standing balance, walking speed and sit-to-stand performance
Quality of Life: Short Form (SF) 36 questionnaire; daily or weekly e-diary
MDietary Analysis: FFQ, 24 hour recall, 3 day diary

 

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Check our Resources on Bone & Joint Health