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SarcopeniaNCT04685382

Association of Protein Intake With Sarcopenia Among Institutionalized Elderly

An observational study of Sarcopenia and Protein Deficiency, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Protein Deficiency
How many people
100 participants
Where
1 siteIndonesia
Study dates
20 May 2019to 30 May 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Subjects were recruited using proportional random sampling method

Who may be able to join

  • Inclusion criteria were being male or female
  • aged more than 60 years old
  • signed inform consent form and literate with help from companion

Who cannot join

  • subjects with history of cancer
  • history of upper and lower extremities weakness
  • history of chronic heart failure disease
  • chronic obstructive pulmonary disease

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Fiastuti Witjaksono

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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

Read the 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.

Keywords
Protein Intake, Sarcopenia, Institutionalized elderly
Medical subject headings
Sarcopenia, Protein Deficiency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: After signing the consent

  2. 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

    Measured: After signing the consent

  3. 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

    Measured: After signing the consent

  4. 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

    Measured: After signing the consent

  5. 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

    Measured: After signing the consent

  6. 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

    Measured: immediately after the procedure

Secondary outcomes (2)

  1. 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

    Measured: After signing the consent

  2. 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 (%)

    Measured: After signing the consent

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2020
  2. Study start20 May 2019
  3. Primary completion30 May 2019
  4. Study completion30 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04685382
Sponsor's protocol ID
19-04-0421
Status last verified
Dec 2020
First submitted
14 Dec 2020
Last updated
28 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Protein Deficiency, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Protein intake of the subject (time frame: After signing the consent). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04685382.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.

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