Clinical trial NCT02276183: Move Study in Healthy Aging People
Official title: Effects of a Test Formula Milk Powder Combined With a Physical Activity Program on Mobility in Healthy Aging Subjects With Joint Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Pain
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-10-28
Enrollment: 55
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in muscle extension isokinetic strength and 4 min speed step
timeFrame: Baseline and visit 7
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References: