Move Study in Healthy Aging People

Not Applicable

Completed

• Conditions: Joint Pain
• Interventions: Dietary Supplement: Nutrition intervention, test formula; Behavioral: progressive physical activity

• Registration Number: NCT02276183
• Lead Sponsor: Société des Produits Nestlé (SPN)

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 available

Study Timeline

• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-28
• Study Start: 2015-04
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-24
• Last Update Posted: 2016-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm1, Nutrition intervention, test formula and activity	Nutrition intervention, test formula	-
Arm1, Nutrition intervention, test formula and activity	progressive physical activity	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in muscle extension isokinetic strength and 4 min speed step	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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China