Malnutrition; ProteinSERIANCT06607718
Nutritional and Exercise Intervention in Older Adults Admitted to the Acute Care Unit (SERIA)
A study testing Resistance Training and Oral Nutritional Supplementation in people with Malnutrition; Protein and Older, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
This is a randomised, parallel, single-blind clinical trial. Objectives: to evaluate: the impact of the intervention on nutritional status, body composition, strength, the prevalence of sarcopenia and physical performance at discharge and three months later.. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition; Protein, Older, Sarcopenia
- What is being tested?
- Resistance Training and Oral Nutritional Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 11 May 2023to 30 Jun 2025
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients admitted to the Unidad de Agudos (Geriatric Acute Care) del Servicio de Geriatría at HU Ramón y Cajal who are at risk of malnutrition or malnutrition (defined with a MNA-SF score ≤ 11) and who sign the informed consent form.
Who cannot join
- patients with estimated discharge within 72 hours.
- Re-admissions (defined as previous admission in the Geriatric Acute Care in the last 3 months)
- Patients taking ONS for more than two weeks.at the time of admission.
- Patients suffering any illness or condition that prevents or contraindicates resistance physical exercise. and oral food intake.
- Food allergies or intolerances that contraindicate the SNO.
- Patients with advanced dementia (GDS stage 7) or palliative care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyperproteic Oral Supplementation With Vitamin D and Resistance Training in Older Patients Admitted to the Acute Unit (SERIA)
This is a randomised, parallel, single-blind clinical trial. Objectives: to evaluate: the impact of the intervention on nutritional status, body composition, strength, the prevalence of sarcopenia and physical performance at discharge and three months later..
Read the detailed description
Design: A randomised controlled clinical trial with four parallel groups is being conducted with older adults admitted to an acute geriatric unit at risk of malnutrition or with malnutrition. The participants are randomly assigned to one of the groups. Three assessment visits are being conducted: at admission, discharge, and three months later.
Setting: The study is being conducted in the Unidad de Agudos del Servicio de Geriatría at Hospital Universitario Ramón y Cajal, by the Servicio Madrileño de Salud (SERMAS).
Interventions: four groups: 1) a resistance training group (RT); 2) an oral nutritional supplementation group (ONS); 3) a combination of RT and ONS (RT+ONS); and a control group (CG). The patients in the RT group follow individualized RT sessions with a physiotherapist daily during the hospitalization and three weekly home sessions on their own after discharge. The sessions are structured according to the recommendations of the American College of Sports Medicine (ACSM), mainly RT.
Study population: A study of malnourished or at-risk outpatients in our setting was used to calculate the sample size. In that study, with an alpha error of 0.05 and a beta of 0.80, the minimum sample size was 14 participants per group. Our objective is to include, at least, 21 participants per group, resulting in a total of 84 participants.
Sociodemographic and clinical variables are being collected (e.g., age, sex, living situation, number of drugs, falls). Information about nutritional and functional status (e.g., MNA, gait speed, Barthel, Lawton, and FAC), body composition (e.g., weight, height, body mass index, appendicular muscle mass index measured by bioimpedanciometry (BIA)), ultrasound measurements of the anterior rectus (area, thickness, and penation angle), and muscle strength (hand grip test) is also collected.
The first descriptive analysis of the variables will include frequencies and percentages for categorical variables and means and standard deviations for continuous variables. Changes in nutritional status will be analysed as well as the interaction between nutrition and exercise by repeated measures ANOVA. The prevalence of sarcopenia and the influence of each component of the sarcopenia definition on physical performance, ADLs, emergency room visits, and new admissions. Additionally, a survival analysis will be performed to compare the four groups. To assess the quality of ultrasound measurement, the relationship between each ultrasound variable and the bioimpedance score, as well as the diagnostic criteria for malnutrition and sarcopenia, will be analysed. Furthermore, ultrasound measurements will be correlated with the estimation of muscle mass using bioimpedance analysis. A p-value less than 0.05 will be considered statistically significant.
The study is being conducted under the ethical standards set forth by the Comité de Ética de Investigación con Medicamentos (CEIm) of the Hospital Universitario Ramón y Cajal. Each participant is informed about the study and signs the informed consent before inclusion. The study has been designed and subsequently evaluated under Law 14/2007 on Biomedical Research, the ethical principles of the Declaration of Helsinki of the World Medical Association on Ethical Principles for Medical Research on Human Beings, as well as the other ethical principles and legal regulations applicable according to the characteristics of the study.
- Conditions
- Malnutrition; Protein, Older, Sarcopenia
- Being tested
- Resistance Training, Oral Nutritional Supplementation, Control Group
- Keywords
- Oral Nutritional Supplementation, Resistance trainning, Sarcopenia, Older adults, Acute Care
- Medical subject headings
- Kwashiorkor, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingOther
Also called RT
Resistance training for elderly patients in the acute care unit.
Oral Nutritional SupplementationDietary supplement
Also called ONS
To receive two daily packs of a hypercaloric and hyperproteic oral nutritional supplement for 3 months.
Control GroupOther
Also called CG
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training (RT) | Experimental | They are performing programmed physical exercise started on the day of admission, focusing on muscle strength gain, and they are being taught how to continue exercising three times a week after discharge from hospital. Lower limb strength exercises (squats and knee extensions) and upper limb strength exercises (elbow flexion, lateral and frontal raises, and tractions) were performed. A progression of the load are being made by increasing one set per month and 2 to 4 repetitions per month depending on the patient's capabilities. Receives: Other: Resistance Training |
| Oral Nutritional Supplementation (ONS) | Experimental | They are receiving a hypercaloric, hyperproteic, oral nutritional supplement with vitamin D and CaHMB (ß-hydroxy-ß-methylbutyrate) (Ensure Plus Advance®), at a dose of two packets per day in two or more doses for 3 months. Receives: Dietary Supplement: Oral Nutritional Supplementation |
| Control Group (CG) | Sham comparator | They are being treated according to standard clinical practice, which includes information from the health professionals on the ward on recommended dietary and exercise guidelines. When the treating team considers the use of an oral nutritional supplement to be indicated, it is being prescribed. Receives: Other: Control Group |
| Resistance Training (RT) and Oral Nutritional Supplementation (ONS) | Experimental | They receive joint treatment Receives: Other: Resistance Training; Dietary Supplement: Oral Nutritional Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Nutritional Assessment (MNA)
Screening tool to help identify malnourished elderly people or those at risk of malnutrition on a scale of 0 to 30. The higher the value, the better the nutritional status of the older adult.
Measured: 12 weeks
Secondary outcomes (10)
Hand grip test
Measurement of hand grip strength using a hand-held dynamometer.
Measured: 12 weeks
Body Mass Index (BMI)
Is a mathematical ratio that associates the mass and the size of an individual BMI = weight / height ^2
Measured: 12 weeks
Appendicular Skeletal Muscle mass Index (ASMI)
It is the sum of muscle masses of the four limbs measured with BIA.
Measured: 12 weeks
4-m-test
It consists of assessing the patient's usual walking speed over a distance of 4 metres.
Measured: 12 weeks
Barthel's index
Test to assess the patient's ability to perform basic activities of daily living on a scale of 0 to 100. The higher the value, the greater the independence of the older adult.
Measured: 12 weeks
Lawton-Brody scale
Test to assess the patient's ability to perform instrumental activities of daily living on a scale of 0 to 8. The higher the score, the greater the functional capacity of the older adult.
Measured: 12 weeks
Functional Ambulation Classification (FAC)
Test to assess a person's ability to walk with a score from 0 to 5. The higher the score, the greater the walking independence.
Measured: 12 weeks
Cross-sectional area
An ultrasound is performed in the middle of the anterior rectus, measuring from the patella to the anteroinferior iliac spine. Through a cross section the image is frozen and the area of the volume of the anterior rectum at that point is traced. The area is noted in cm^2.
Measured: 12 weeks
Thickness
An ultrasound is performed in the middle of the anterior rectus, measuring from the patella to the anteroinferior iliac spine. Through a cross section the image is frozen and a straight line of the thickness of the center of the anterior rectus is drawn at that point. The distance is noted in mm.
Measured: 12 weeks
Penile angle of a muscle
An ultrasound is performed in the middle of the anterior rectus, measuring from the patella to the anteroinferior iliac spine. Unlike the other measurements, the ultrasound image is taken in the longitudinal section. The penile angle of a muscle is the orientation of the muscle fibers in relation to the connective tissue/tendon. It is taken by fixing one side of the angle on the connective tissue and the other side on the orientation of the muscle fibers. The value is noted in degrees.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start11 May 2023
- Primary completion30 Jan 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition; ProteinStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, controlled, pragmatic study with blinded outcome measurement.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatriz Montero-Errasquín, Dra., Principal investigator, Hospital Ramon y Cajal.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607718
- Sponsor's protocol ID
- 041/23
- Acronym
- SERIA
- Status last verified
- Aug 2025
- First submitted
- 4 Sep 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal information will be shared. At the time of enrolment, each participant will be given a code. The full database of outcome variables will also not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperproteic Oral Supplementation With Vitamin D and Resistance Training in Older Patients Admitted to the Acute Unit (SERIA)
- ClinicalTrials.gov ID
- NCT06607718
- Acronym / sponsor ID
- SERIA / 041/23
- Conditions
- Malnutrition; Protein, Older, Sarcopenia
- Keywords
- Oral Nutritional Supplementation, Resistance trainning, Sarcopenia, Older adults, Acute Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 23 Sep 2024 (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 is a randomised, parallel, single-blind clinical trial. Objectives: to evaluate: the impact of the intervention on nutritional status, body composition, strength, the prevalence of sarcopenia and physical performance at discharge and three months later..
Detailed description
Design: A randomised controlled clinical trial with four parallel groups is being conducted with older adults admitted to an acute geriatric unit at risk of malnutrition or with malnutrition. The participants are randomly assigned to one of the groups. Three assessment visits are being conducted: at admission, discharge, and three months later.
Setting: The study is being conducted in the Unidad de Agudos del Servicio de Geriatría at Hospital Universitario Ramón y Cajal, by the Servicio Madrileño de Salud (SERMAS).
Interventions: four groups: 1) a resistance training group (RT); 2) an oral nutritional supplementation group (ONS); 3) a combination of RT and ONS (RT+ONS); and a control group (CG). The patients in the RT group follow individualized RT sessions with a physiotherapist daily during the hospitalization and three weekly home sessions on their own after discharge. The sessions are structured according to the recommendations of the American College of Sports Medicine (ACSM), mainly RT.
Study population: A study of malnourished or at-risk outpatients in our setting was used to calculate the sample size. In that study, with an alpha error of 0.05 and a beta of 0.80, the minimum sample size was 14 participants per group. Our objective is to include, at least, 21 participants per group, resulting in a total of 84 participants.
Sociodemographic and clinical variables are being collected (e.g., age, sex, living situation, number of drugs, falls). Information about nutritional and functional status (e.g., MNA, gait speed, Barthel, Lawton, and FAC), body composition (e.g., weight, height, body mass index, appendicular muscle mass index measured by bioimpedanciometry (BIA)), ultrasound measurements of the anterior rectus (area, thickness, and penation angle), and muscle strength (hand grip test) is also collected.
The first descriptive analysis of the variables will include frequencies and percentages for categorical variables and means and standard deviations for continuous variables. Changes in nutritional status will be analysed as well as the interaction between nutrition and exercise by repeated measures ANOVA. The prevalence of sarcopenia and the influence of each component of the sarcopenia definition on physical performance, ADLs, emergency room visits, and new admissions. Additionally, a survival analysis will be performed to compare the four groups. To assess the quality of ultrasound measurement, the relationship between each ultrasound variable and the bioimpedance score, as well as the diagnostic criteria for malnutrition and sarcopenia, will be analysed. Furthermore, ultrasound measurements will be correlated with the estimation of muscle mass using bioimpedance analysis. A p-value less than 0.05 will be considered statistically significant.
The study is being conducted under the ethical standards set forth by the Comité de Ética de Investigación con Medicamentos (CEIm) of the Hospital Universitario Ramón y Cajal. Each participant is informed about the study and signs the informed consent before inclusion. The study has been designed and subsequently evaluated under Law 14/2007 on Biomedical Research, the ethical principles of the Declaration of Helsinki of the World Medical Association on Ethical Principles for Medical Research on Human Beings, as well as the other ethical principles and legal regulations applicable according to the characteristics of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomised, controlled, pragmatic study with blinded outcome measurement.
| Arm | Type | Receives |
|---|---|---|
| Resistance Training (RT) | Experimental | Other: Resistance TrainingThey are performing programmed physical exercise started on the day of admission, focusing on muscle strength gain, and they are being taught how to continue exercising three times a week after discharge from hospital. Lower limb strength exercises (squats and knee extensions) and upper limb strength exercises (elbow flexion, lateral and frontal raises, and tractions) were performed. A progression of the load are being made by increasing one set per month and 2 to 4 repetitions per month depending on the patient's capabilities. |
| Oral Nutritional Supplementation (ONS) | Experimental | Dietary Supplement: Oral Nutritional SupplementationThey are receiving a hypercaloric, hyperproteic, oral nutritional supplement with vitamin D and CaHMB (ß-hydroxy-ß-methylbutyrate) (Ensure Plus Advance®), at a dose of two packets per day in two or more doses for 3 months. |
| Control Group (CG) | Sham comparator | Other: Control GroupThey are being treated according to standard clinical practice, which includes information from the health professionals on the ward on recommended dietary and exercise guidelines. When the treating team considers the use of an oral nutritional supplement to be indicated, it is being prescribed. |
| Resistance Training (RT) and Oral Nutritional Supplementation (ONS) | Experimental | Other: Resistance Training, Dietary Supplement: Oral Nutritional SupplementationThey receive joint treatment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the Unidad de Agudos (Geriatric Acute Care) del Servicio de Geriatría at HU Ramón y Cajal who are at risk of malnutrition or malnutrition (defined with a MNA-SF score ≤ 11) and who sign the informed consent form.
Key exclusion criteria (6 listed)
- patients with estimated discharge within 72 hours.
- Re-admissions (defined as previous admission in the Geriatric Acute Care in the last 3 months)
- Patients taking ONS for more than two weeks.at the time of admission.
- Patients suffering any illness or condition that prevents or contraindicates resistance physical exercise. and oral food intake.
- Food allergies or intolerances that contraindicate the SNO.
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 |
|---|---|---|
| Resistance TrainingAlso: RTResistance training for elderly patients in the acute care unit. | Other | Resistance Training (RT), Resistance Training (RT) and Oral Nutritional Supplementation (ONS) |
| Oral Nutritional SupplementationAlso: ONSTo receive two daily packs of a hypercaloric and hyperproteic oral nutritional supplement for 3 months. | Dietary supplement | Oral Nutritional Supplementation (ONS), Resistance Training (RT) and Oral Nutritional Supplementation (ONS) |
| Control GroupAlso: CGNo intervention | Other | Control Group (CG) |
Primary outcome
Mini Nutritional Assessment (MNA)
Time frame: 12 weeks
Screening tool to help identify malnourished elderly people or those at risk of malnutrition on a scale of 0 to 30. The higher the value, the better the nutritional status of the older adult.
10 secondary outcomes
Hand grip test
Time frame: 12 weeks
Body Mass Index (BMI)
Time frame: 12 weeks
Appendicular Skeletal Muscle mass Index (ASMI)
Time frame: 12 weeks
4-m-test
Time frame: 12 weeks
Barthel's index
Time frame: 12 weeks
Lawton-Brody scale
Time frame: 12 weeks
Functional Ambulation Classification (FAC)
Time frame: 12 weeks
Cross-sectional area
Time frame: 12 weeks
Thickness
Time frame: 12 weeks
Penile angle of a muscle
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No. No personal information will be shared. At the time of enrolment, each participant will be given a code. The full database of outcome variables will also not be shared.
Related trials for Malnutrition; Protein
Active, not recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
Recruiting
Suitability of a High-energy, Low-protein Formula (Renalive® LP)
CKD, Low Protein Dietary Intake
Active, not recruiting
Choline to Improve Malnutrition and Enhance Cognition
Severe Acute Malnutrition, Cognitive Impairment
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.
Beatriz Montero-Errasquín, Dra. principal investigator
Hospital Ramon y Cajal.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training and Oral Nutritional Supplementation in people with Malnutrition; Protein and Older, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 6 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 7 Aug 2025. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Mini Nutritional Assessment (MNA) (time frame: 12 weeks). 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 7 Aug 2025.