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Move Study in Healthy Aging People

Primary Purpose

Joint Pain

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nutrition intervention, test formula
progressive physical activity
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Joint Pain

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm1, Nutrition intervention, test formula and activity

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 21, 2014
Last Updated
November 24, 2016
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT02276183
Brief Title
Move Study in Healthy Aging People
Official Title
Effects of a Test Formula Milk Powder Combined With a Physical Activity Program on Mobility in Healthy Aging Subjects With Joint Discomfort
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm1, Nutrition intervention, test formula and activity
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition intervention, test formula
Intervention Type
Behavioral
Intervention Name(s)
progressive physical activity
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline in muscle extension isokinetic strength and 4 min speed step
Description
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.
Time Frame
Baseline and visit 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

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Move Study in Healthy Aging People

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