- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07443722
The Beneficial Effects of Nutritional Supplements on the Malnutrition and Sarcopenia Risk in Elderly Living Alone
February 26, 2026 updated by: Suh-Ching, Yang, Taipei Medical University
This study aims to examine the effects of meal delivery services on the nutritional status and mobility of malnourished older adults living alone at a foundation in Taoyuan.
Participants will continue their usual diet and consume a daily oral nutrition supplement (ONS) of their preferred type (instant powder with milk or soy milk), provided monthly by social workers for 12 months.
Nutritional assessments will be conducted every three months, including the Mini Nutritional Assessment (MNA), anthropometric measures, and 24-hour dietary recall.
Mobility will be evaluated using grip strength, walking speed, chair stand test, and calf circumference.
Psychological outcomes will be assessed every six months using a quality-of-life questionnaire and the short form of the Geriatric Depression Scale.
This study is expected to determine whether regular meal delivery services can improve nutritional status, mobility, quality of life, and depressive symptoms among elderly individuals living alone.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
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
-
-
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Taipei, Taiwan, 110
- Taipei Medical University
-
-
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
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Mini Nutritional Assessment (MNA) score < 23.5, Body mass index (BMI) < 25 kg/m², Calf circumference: < 34 cm for men and < 33 cm for women, Handgrip strength: < 28 kg for men and < 18 kg for women
Exclusion Criteria:
- Presence of swallowing difficulties (dysphagia), Chronic renal failure, Bedridden and unable to ambulate, Older adults with chronic conditions-such as hypertension, cardiovascular disease, or poorly controlled diabetes-who are deemed unsuitable after professional assessment
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
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: malnourished older adults living alone
|
Without adjusting their daily diet, they take oral nutrition supplements (ONS) once a day according to their favorite combination.
The items include: instant powder with milk drinks or soy milk, which are distributed by social workers every month for a total of 12 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mini Nutritional Assessment (MNA) score
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
|
Nutritional status is assessed using the Mini Nutritional Assessment (MNA).
The total MNA score ranges from 0 to 30, with lower scores indicating poorer nutritional status.
The score is expressed as a total point value.
|
Baseline, 3 months, 6 months, 9 months and 12 months
|
|
Change in body weight
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
|
Body weight is measured using a calibrated digital scale and expressed in kilograms (kg).
|
Baseline, 3 months, 6 months, 9 months and 12 months
|
|
Change in body mass index (BMI)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
|
BMI is calculated as body weight in kilograms divided by height in meters squared (kg/m²).
|
Baseline, 3 months, 6 months, 9 months, 12 months
|
|
Change in skeletal muscle mass
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
|
Skeletal muscle mass is measured using a calibrated digital body composition analyzer based on bioelectrical impedance analysis (BIA) and expressed in percentage (%).
|
Baseline, 3 months, 6 months, 9 months, 12 months
|
|
Changes in calf circumference
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
|
Calf circumference is used as a surrogate indicator of muscle mass.
Calf circumference is measured at the widest point of the non-dominant calf using a non-elastic measuring tape and expressed in centimeters (cm).
|
Baseline, 3 months, 6 months, 9 months and 12 months
|
|
Changes in muscle strength
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
|
Muscle strength is assessed using handgrip dynamometry and expressed in kilograms (kg).
|
Baseline, 3 months, 6 months, 9 months and 12 months
|
|
Change in five-times chair stand test time
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
|
Lower extremity muscle strength will be assessed using the five-times chair stand test.
The time required to complete five consecutive chair rises will be recorded in seconds (s).
|
Baseline, 3 months, 6 months, 9 months and 12 months
|
|
Change in gait speed
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
|
Usual gait speed is assessed using a standardized 6-meter walk test.
Participants will be instructed to walk at their usual pace, and walking speed will be expressed in meters per second (m/s).
|
Baseline, 3 months, 6 months, 9 months and 12 months
|
|
Changes in daily total energy intake
Time Frame: Baseline, 3 months, 6 months, 9 months and 12 months
|
Daily energy intake is estimated using a 24-hour dietary recall and analyzed using nutrition analysis software.
Energy intake will be expressed in kilocalories per day (kcal/day).
|
Baseline, 3 months, 6 months, 9 months and 12 months
|
|
Change in daily protein intake
Time Frame: Baseline, 3months, 6 months, 9 months, 12 months
|
Daily protein intake is estimated using a 24-hour dietary recall and analyzed using nutrition analysis software.
Protein intake is expressed in grams per day (g/day).
|
Baseline, 3months, 6 months, 9 months, 12 months
|
|
Change in daily carbohydrate intake
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
|
Daily carbohydrate intake is estimated using a 24-hour dietary recall and expressed in grams per day (g/day).
|
Baseline, 3 months, 6 months, 9 months, 12 months
|
|
Change in daily fat intake
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
|
Daily fat intake is estimated using a 24-hour dietary recall and expressed in grams per day (g/day).
|
Baseline, 3 months, 6 months, 9 months, 12 months
|
|
Change in Short-Form Geriatric Depression Scale (GDS-5) score
Time Frame: Baseline, 6 months and 12 months
|
Depressive symptoms is assessed using the 5-item Short-Form Geriatric Depression Scale (GDS-5).
The total score ranges from 0 to 5, with higher scores indicating more severe depressive symptoms.
Scores is expressed as total points.
|
Baseline, 6 months and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) score
Time Frame: Baseline, 6 months and 12 months
|
Quality of life is assessed using the Taiwan version of the World Health Organization Quality of Life-BREF (WHOQOL-BREF).
The instrument includes 26 items covering four domains (physical health, psychological health, social relationships, and environment).
Domain scores is transformed to a scale ranging from 0 to 100, with higher scores indicating better quality of life.
|
Baseline, 6 months and 12 months
|
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)
September 1, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
February 18, 2026
First Submitted That Met QC Criteria
February 26, 2026
First Posted (Actual)
March 2, 2026
Study Record Updates
Last Update Posted (Actual)
March 2, 2026
Last Update Submitted That Met QC Criteria
February 26, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N202507097
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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