Move Study in Healthy Aging People

NCT ID: NCT02276183

Last Updated: 2016-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-08-31

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.

Conditions

Joint Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm1, Nutrition intervention, test formula and activity

Group Type: EXPERIMENTAL

Nutrition intervention, test formula

Intervention Type: DIETARY_SUPPLEMENT

progressive physical activity

Intervention Type: BEHAVIORAL

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)

Interventions

Nutrition intervention, test formula

Intervention Type: DIETARY_SUPPLEMENT

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)

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital

Beijing, , China

Countries

China

Other Identifiers

13.25 NRC

Identifier Type: -

Identifier Source: org_study_id