Move Study in Healthy Aging People

November 24, 2016 updated by: Nestlé

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm1, Nutrition intervention, test formula and activity
Dietary supplement: Nutrition intervention, test formula
Behavioral: 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and visit 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nestlé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13.25 NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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