Valid Malnutrition ConditionNCT07443722
The Beneficial Effects of Nutritional Supplements on the Malnutrition and Sarcopenia Risk in Elderly Living Alone
A study testing milk drinks in people with Valid Malnutrition Condition and Valid Sarcopenia, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Valid Malnutrition Condition, Valid Sarcopenia, Valid Frailty
- What is being tested?
- milk drinks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- milk drinks
- Keywords
- meal delivery service, nutritional status, mobility, quality of life, depression, elderly people living alone
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milk drinksDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| malnourished older adults living alone | Experimental | Not described Receives: Dietary Supplement: milk drinks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mini Nutritional Assessment (MNA) score
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.
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Change in body weight
Body weight is measured using a calibrated digital scale and expressed in kilograms (kg).
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Change in body mass index (BMI)
BMI is calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in skeletal muscle mass
Skeletal muscle mass is measured using a calibrated digital body composition analyzer based on bioelectrical impedance analysis (BIA) and expressed in percentage (%).
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Changes in calf circumference
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).
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Changes in muscle strength
Muscle strength is assessed using handgrip dynamometry and expressed in kilograms (kg).
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Change in five-times chair stand test time
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).
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Change in gait speed
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).
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Changes in daily total energy intake
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).
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Change in daily protein intake
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).
Measured: Baseline, 3months, 6 months, 9 months, 12 months
Change in daily carbohydrate intake
Daily carbohydrate intake is estimated using a 24-hour dietary recall and expressed in grams per day (g/day).
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in daily fat intake
Daily fat intake is estimated using a 24-hour dietary recall and expressed in grams per day (g/day).
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Short-Form Geriatric Depression Scale (GDS-5) score
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.
Measured: Baseline, 6 months and 12 months
Secondary outcomes (1)
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) score
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.
Measured: Baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Sep 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valid Malnutrition ConditionStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suh-Ching, Yang, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443722
- Sponsor's protocol ID
- N202507097
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Beneficial Effects of Nutritional Supplements on the Malnutrition and Sarcopenia Risk in Elderly Living Alone
- ClinicalTrials.gov ID
- NCT07443722
- Acronym / sponsor ID
- N202507097
- Keywords
- meal delivery service, nutritional status, mobility, quality of life, depression, elderly people living alone
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| malnourished older adults living alone | Experimental | Dietary Supplement: milk drinks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| milk drinksWithout 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. | Dietary supplement | malnourished older adults living alone |
Primary outcome
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.
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).
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).
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 (%).
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).
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).
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).
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).
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).
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).
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).
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).
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.
1 secondary outcome
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) score
Time frame: Baseline, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing milk drinks in people with Valid Malnutrition Condition and Valid Sarcopenia, run by Taipei Medical University at 1 site in Taiwan.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Mini Nutritional Assessment (MNA) score (time frame: Baseline, 3 months, 6 months, 9 months and 12 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2026.