Association of Protein Intake With Sarcopenia Among Institutionalized Elderly

Sarcopenia Clinical Trial

Official title:

Association of Protein Intake With Sarcopenia Among Institutionalized Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04685382
• Other study ID #: 19-04-0421
• Status: Completed
• Start date: May 20, 2019
• Est. completion date: May 30, 2019

Study information

• Verified date: December 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study has purpose to investigated the association of protein intake with sarcopenia in the institutionalized elderly at south tangerang

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Inclusion criteria were being male or female

2. aged more than 60 years old

3. signed inform consent form and literate with help from companion

Exclusion Criteria:

1. subjects with history of cancer

2. history of upper and lower extremities weakness

3. history of chronic heart failure disease

4. chronic obstructive pulmonary disease

Related Conditions & MeSH terms

• Protein Deficiency
• Sarcopenia

Locations

Country	Name	City	State
Indonesia	Fiastuti Witjaksono	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein intake of the subject	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
Primary	Distribution of sarcopenia subject in the institutionalized elderly	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
Primary	Characteristic of fat free mass subject	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
Primary	Characteristic of handgrip strength subject	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
Primary	Characteristic of physical performance subject	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
Primary	Association of protein intake with sarcopenia	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	Nutritional status of the subjects	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
Secondary	Barthel index of the subject	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