Move Study in Healthy Aging People

Study Overview
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Brief Summary
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Bone and muscle losses occur during ageing leading to increased risk of osteoporosis (there are more than 200 million people affected by osteoporosis worldwide), sarcopenia, loss of functionality and mobility. From around 45-50 years onwards, there is a progressive loss of muscle mass and strength (sarcopenia). This is partially due to an impairment of muscle protein synthesis in response to dietary proteins. Insufficient dietary protein may contribute to age-related loss of lean body mass (LBM) and strength which ultimately affects body movement. Key ingredients in selected investigational product are:Milk proteins, Calcium, Vitamin D, Vitamin C, Glucosamine Sulfate, Zinc. They have effects to improve physical mobility and functionality. The investigators expect improved effects of a nutritional intervention combined with a physical activity program on mobility in healthy aging subjects with joint discomfort.

Official Title
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Effects of a Test Formula Milk Powder Combined With a Physical Activity Program on Mobility in Healthy Aging Subjects With Joint Discomfort

Conditions
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Joint Pain

Intervention / Treatment
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* Dietary Supplement: Nutrition intervention, test formula
* Behavioral: progressive physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Target 45-65 y old Suffering from (knee) pain. VAS on pain assessment <= 4 on a range 0 to 10 20<BMI<28 Time since menopause above 2y iPAQ (International Physical Activity Questionnaire) score <600 Exclusion Criteria: OA diagnosed Medicine treatment Chronic pain killers treatment for more than 7 consecutive days with a washout period of 2 weeks between 2 periods of treatment Under corticoid, hormone (adrenal, thyroid) treatment Traditional herbal medicine: in particular with claims on strengthening tendons and bones. This point will be included in FFQ (see annex) and evaluate. Subjects with chronic tablets supplementation ( calcium or drinking milk over 5 day wk-1 will be excluded, vitamin D, GS, or any with effect on bone and joints ) (set up a FFQ to specially investigate intakes of calcium tablets, milk and animal foods) Pregnancy Subject with knee/joint surgery/replacement and CLA (Cross Ligament) injury History of relevant digestive disease, organic disease of heart, liver or kidney, severe function disorder of liver or kidney, metabolic/endocrine , neurological disease (e.g., Parkinson disease, stroke) with residual impairment, vertigo Anaemia Unable to carry out functional tests and questionnaires correctly (KOOS, physical activity) Lower or upper extremity surgery or fracture in the last 3 months Currently participating or having participated in another clinical trial in the three previous months

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm1, Nutrition intervention, test formula and activity<br> | Dietary Supplement: Nutrition intervention, test formula<br> <br> Behavioral: progressive physical activity<br>* Tai Chi; dynamic strength training (knee extension, knee flexion, hip extension, side leg raise, plantar flexion); flexibility warm up and cool down (shoulder and upper arm stretch, hamstrings stretch, calf stretch, ankle stretch); aerobic fitness training(walking on even flat ground); balance training(standing on one foot; heel-to-toe walk; toe stand)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in muscle extension isokinetic strength and 4 min speed step | Change from baseline and muscle(quadriceps)extension isokinetic strength (peak torque) and 4 min speed step will be measured as the change of musculoskeletal functionality and mobitliy. | Baseline and visit 7 |