Move Study in Healthy Aging People

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

Tracking Information

• First Submitted Date: October 21, 2014
• First Posted Date: October 28, 2014
• Last Update Posted Date: November 28, 2016
• Study Start Date: April 2015
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2014)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Joint Pain

Intervention

• 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)

Study Arms

Experimental: Arm1, Nutrition intervention, test formula and activity

Interventions:

• Dietary Supplement: Nutrition intervention, test formula
• Behavioral: progressive physical activity

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: October 27, 2014): 55
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02276183
• Other Study ID Numbers: 13.25 NRC
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Nestlé
• Study Sponsor: Nestlé
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Nestlé
• Verification Date: November 2016