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Move Study in Healthy Aging People

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ClinicalTrials.gov Identifier: NCT02276183
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Nestlé

Study Description
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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.


Condition or disease Intervention/treatment Phase
Joint Pain Dietary Supplement: Nutrition intervention, test formula Behavioral: progressive physical activity Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : April 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm1, Nutrition intervention, test formula and activity Dietary Supplement: Nutrition intervention, test formula
Behavioral: progressive physical activity
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)


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in muscle extension isokinetic strength and 4 min speed step [ Time Frame: Baseline and visit 7 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276183


Locations
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China
Peking University Third Hospital
Beijing, China
Sponsors and Collaborators
Nestlé
More Information
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02276183    
Other Study ID Numbers: 13.25 NRC
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations