- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03566758
Muscle Mass and Nutritional Risk in Older Adults
April 24, 2019 updated by: University of Florida
The Association Between Muscle Mass and Nutritional Risk by COAST in Older Adults
This study aims to compare the COAST (comprehensive older adult screening tool) to muscle mass as determined by BIA (bioelectric impedance analysis) and thus, determine if the COAST is a valid predictor of muscle loss in older adults.
This study follows a comparison of COAST to MNA and will further test the validity of the COAST nutrition screening tool.
Study Overview
Status
Completed
Conditions
Detailed Description
The association between muscle mass, as determined by BIA (bioelectric impedance analysis), and the recently developed COAST (Comprehensive Older Adult Screening Tool) has not been studied.
Therefore, the main objective of this study is to test the correlations between muscle mass, measured by BIA, and COAST.
The population to be studied will be older adults (n=150).
Participants will be included if they are 60 years or older, willing to have weight, height, handgrip and body composition measured, willing to provided demographic information and answer questions related to their nutritional and health status.
Individuals will be excluded if they have had recent surgery to the hands, severe rheumatoid arthritis in both hands or have a pacemaker or other implanted device.
Participants will be recruited from community groups in Florida.
Participants muscle mass will be measured using BIA.
Also, their handgrip strength will be tested using a dynamometer.
Weight and height will be measured and demographic information will be collected.
In addition, the participants will be given COAST (5 questions related to their nutritional and health status).
The associations among BIA, handgrip strength and the COAST will be analyzed.
Study Type
Observational
Enrollment (Actual)
136
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
-
-
Florida
-
Gainesville, Florida, United States, 32611
- Food Science and Human Nutrition Department
-
-
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
Ages Eligible for Study
60 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Older adults
Description
Inclusion Criteria:
- 60 -100 years of age
- willing to weight, height, handgrip and body composition measured, willing to provide demographic information and answer questions related to their nutritional and health status
Exclusion Criteria:
- recent surgery to the hands, severe rheumatoid arthritis in both hands or have a pacemaker or other implanted device.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COAST (Comprehensive Older Adult Screening Tool) score
Time Frame: baseline only
|
Ability of the COAST score to predict depleted muscle mass.
A five question survey, scored from 0 to 8 points; 8 being the maximum score.
|
baseline only
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
June 11, 2018
Primary Completion (Actual)
December 27, 2018
Study Completion (Actual)
April 23, 2019
Study Registration Dates
First Submitted
June 12, 2018
First Submitted That Met QC Criteria
June 21, 2018
First Posted (Actual)
June 25, 2018
Study Record Updates
Last Update Posted (Actual)
April 25, 2019
Last Update Submitted That Met QC Criteria
April 24, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- IRB201801247
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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