NCT04685382

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2019

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

10 days

First QC Date

December 14, 2020

Last Update Submit

December 21, 2020

Conditions

Keywords

Protein IntakeSarcopeniaInstitutionalized elderly

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Nutritional status of the subjects

    After signing the consent

  • Barthel index of the subject

    After signing the consent

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects were recruited using proportional random sampling method

You may qualify if:

  • aged more than 60 years old
  • signed inform consent form and literate with help from companion

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fiastuti Witjaksono

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

SarcopeniaProtein Deficiency

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Fiastuti Witjaksono

    Department of Nutrition, Faculty of Medicine of Universitas Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. dr. Fiastuti Witjaksono, MKM, MS, Sp.GK (K)

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 28, 2020

Study Start

May 20, 2019

Primary Completion

May 30, 2019

Study Completion

May 30, 2019

Last Updated

December 28, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations