Move Study in Healthy Aging People

NCT02276183 | Completed

• 1 other identifier: 13.25 NRC
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Arm1, Nutrition intervention, test formula and activity

EXPERIMENTAL

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

Interventions

Nutrition intervention, test formula DIETARY_SUPPLEMENT

Arm1, Nutrition intervention, test formula and activity

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)

Arm1, Nutrition intervention, test formula and activity

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Target 45-65 y old
• Suffering from (knee) pain. VAS on pain assessment \<= 4 on a range 0 to 10
• \<BMI\<28
• Time since menopause above 2y
• iPAQ (International Physical Activity Questionnaire) score \<600

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Arthralgia

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 28, 2014
• Study Start: April 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

CN (1)