- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04685382
Association of Protein Intake With Sarcopenia Among Institutionalized Elderly
Study Overview
Status
Conditions
Detailed Description
Data were collected using interview with subjects or with care giver to know the basic characteristic of subjects. Anthropometric measurements were done body weight in kilograms was measured using SECA scale. Body height in meters was predicted by knee height measurement using knee height caliper. Body mass index (BMI) was calculated as weight per height square. Fat free mass was examined using bioelectrical impedance analyzer Tanita type SC-330. Independency was assessed using Barthel index. Protein intake was measured using 2x24 hour food recall and analyzed using a computer program Nutrisurvey 2007, data were compare to Recommended Dietary Allowances established for Indonesian 2018. Handgrip muscle strength was examined using Jamar handgrip dynamometer. Physical performance was measured using Short Physical Performance Battery test. Sarcopenia was diagnosed using Asian Working Group on Sarcopenia.
All data collected were analyzed using Statistical Package for the Social Science (SPSS) version 20 for windows. Nominal data were described using frequency, n (%). Normality of data was tested using Kolmogorov-Smirnov test with normal distribution (p>0.05) described using mean and SD while not normal distribution (p<0.05) described using median and range minimum-maximum. The investigators used Independent T-test analysis to investigate the association.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Fiastuti Witjaksono
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Inclusion criteria were being male or female
- aged more than 60 years old
- signed inform consent form and literate with help from companion
Exclusion Criteria:
- subjects with history of cancer
- history of upper and lower extremities weakness
- history of chronic heart failure disease
- chronic obstructive pulmonary disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protein intake of the subject
Time Frame: After signing the consent
|
to assessed protein intake of the subject using 2x24 hour food recall and analyzed using a computer program Nutrisurvey 2007, data were compare to Recommended Dietary Allowances established for Indonesian 2018
|
After signing the consent
|
Distribution of sarcopenia subject in the institutionalized elderly
Time Frame: After signing the consent
|
to investigate the distribution of sarcopenia subject using Asian Working Group Of Sarcopenia for diagnostic (fat Free Mass, handgrip strength,physical performance) Sarcopenia categorized low muscle mass (fat free mass) and either low muscular strength or low physical performance
|
After signing the consent
|
Characteristic of fat free mass subject
Time Frame: After signing the consent
|
to examine fat free mas of the subject using bioelectrical impedance analyzer Tanita type SC-330 and classified by Asian gender and aged Male : Normal 53,30±4,79 kg Female : Normal 37,96±3,41 kg
|
After signing the consent
|
Characteristic of handgrip strength subject
Time Frame: After signing the consent
|
to assessed handgrip strength of the subject using Jamar handgrip dynamometer, assessment criteria based on the Asian Working Group on Sarcopenia Male : Normal > 26 kg Female : > 18 kg
|
After signing the consent
|
Characteristic of physical performance subject
Time Frame: After signing the consent
|
to examine physical performance (lower extremity strength) using Short Physical Performance Battery test.
Classified using Asian Working Group on Sarcopenia Good physical performance score ≥9
|
After signing the consent
|
Association of protein intake with sarcopenia
Time Frame: immediately after the procedure
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to investigate the association of protein intake with sarcopenia.
After protein intake and sarcopenia analysis were completed.
The investigators used Independent T-test to analyzed the association protein intake between sarcopenia subject compare to non-sarcopenia subject
|
immediately after the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutritional status of the subjects
Time Frame: After signing the consent
|
to investigate nutritional status using anthropometric measurements were done body weight in kilograms was measured using SECA scale. Body height in meters was predicted by knee height measurement using knee height caliper. Body mass index (BMI) was calculated as weight per height square (kg/m2). Nutritional status categorized using WHO Asia Pacific body mass index. Categorized: < 18,5 kg/m2 : underweight 18,5-22,9 kg/m2: normal 23-24,9 kg/m2: overweight >25 kg/m2: obese 1 ≥30 kg/m2 : obese 2 |
After signing the consent
|
Barthel index of the subject
Time Frame: After signing the consent
|
to know independency of the subject using barthel index scoring Scoring: Independent : 20 Mild Dependency : 12-19 Moderate Dependency : 9-11 Severe Dependency : 5-8 Total : 0-4 Independent, n (%) Mild Dependency, n (%) Moderate Dependency, n (%) Severe Dependency, n (%) |
After signing the consent
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fiastuti Witjaksono, Department of Nutrition, Faculty of Medicine of Universitas Indonesia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-04-0421
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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