Move Study in Healthy Aging People

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.

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Key information

Conditions

Joint Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition intervention, test formula

Dietary Supplement

progressive physical activity

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)

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Oct 28, 2014
Registry last updated: Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed