Move Study in Healthy Aging People

Joint Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276183
• Other study ID #: 13.25 NRC
• Status: Completed
• Phase: N/A
• First received: October 21, 2014
• Last updated: November 24, 2016
• Start date: April 2015
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthralgia
• 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)

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No