SarcopeniaNCT06634316
Sarcopenia in Patients With Heart Failure
A study testing Mediterranean diet, Hypercaloric, hyperproteic oral nutritional supplement and Protein module in people with Sarcopenia, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Mediterranean diet, Hypercaloric, hyperproteic oral nutritional supplement and Protein module
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2024to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a previous admission due to HF in the previous 12 months
- Moderate or severe LVEF
- Both sexs
- Age >18 years old.
Who cannot join
- MDRD <15 ml/min
- End-stage liver disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Management of Sarcopenia in Patients With Heart Failure
Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients. There is a lack of evidence for supporting its use or the use of protein modules in other clinical conditions including patients with heart failure
- Conditions
- Sarcopenia
- Being tested
- Mediterranean diet, Hypercaloric, hyperproteic oral nutritional supplement, Protein module, Vitamin D supplementation, Physical exercise
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietOther
Mediterranean diet recommendations and daily physical exercise
Hypercaloric, hyperproteic oral nutritional supplementDietary supplement
Hypercaloric, hyperproteic oral supplement combined with Mediterranean diet recommendations (2 per day) and daily physical exercise
Protein moduleDietary supplement
Protein module (10g/day) combined with Mediterranean diet recommendations and daily physical exercise
Vitamin D supplementationCombination product
Calcifediol supplement administered orally in order to reach sufficiency levels (30 ng/ml)
Physical exerciseCombination product
Physical exercise adapted to patients with heart failure (Cardiac rehabilitation)
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet | Active comparator | Mediterranean diet and physical exercise Receives: Other: Mediterranean diet; Combination Product: Vitamin D supplementation; Combination Product: Physical exercise |
| Standard hypercaloric hyperproteic Oral supplement | Experimental | Standard hypercaloric hyperproteic oral supplement plus Mediterranean diet and physical exercise Receives: Other: Mediterranean diet; Dietary Supplement: Hypercaloric, hyperproteic oral nutritional supplement; Combination Product: Vitamin D supplementation; Combination Product: Physical exercise |
| Protein module | Experimental | Protein module (10g/day) plus Mediterranean diet and physical exercise Receives: Other: Mediterranean diet; Dietary Supplement: Protein module; Combination Product: Vitamin D supplementation; Combination Product: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Changes in muscle mass
Measured: 6 months
Functionality
Changes in functionality determined by the up and go test
Measured: 6 months
Secondary outcomes (2)
Albumin
Changes in serum albumin levels (g/dl)
Measured: 6 months
C-RP
Changes in serum C-RP (g/dl)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start15 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634316
- Sponsor's protocol ID
- Insuficiencia cardiaca 2
- Status last verified
- May 2025
- First submitted
- 23 Aug 2023
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Management of Sarcopenia in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT06634316
- Acronym / sponsor ID
- Insuficiencia cardiaca 2
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Oct 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.
Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients. There is a lack of evidence for supporting its use or the use of protein modules in other clinical conditions including patients with heart failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet | Active comparator | Other: Mediterranean diet, Combination Product: Vitamin D supplementation, Combination Product: Physical exerciseMediterranean diet and physical exercise |
| Standard hypercaloric hyperproteic Oral supplement | Experimental | Other: Mediterranean diet, Dietary Supplement: Hypercaloric, hyperproteic oral nutritional supplement, Combination Product: Vitamin D supplementation, Combination Product: Physical exerciseStandard hypercaloric hyperproteic oral supplement plus Mediterranean diet and physical exercise |
| Protein module | Experimental | Other: Mediterranean diet, Dietary Supplement: Protein module, Combination Product: Vitamin D supplementation, Combination Product: Physical exerciseProtein module (10g/day) plus Mediterranean diet and physical exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a previous admission due to HF in the previous 12 months
- Moderate or severe LVEF
- Both sexs
- Age >18 years old.
Key exclusion criteria (2 listed)
- MDRD <15 ml/min
- End-stage liver disease.
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 |
|---|---|---|
| Mediterranean dietMediterranean diet recommendations and daily physical exercise | Other | Mediterranean diet, Protein module, Standard hypercaloric hyperproteic Oral supplement |
| Hypercaloric, hyperproteic oral nutritional supplementHypercaloric, hyperproteic oral supplement combined with Mediterranean diet recommendations (2 per day) and daily physical exercise | Dietary supplement | Standard hypercaloric hyperproteic Oral supplement |
| Protein moduleProtein module (10g/day) combined with Mediterranean diet recommendations and daily physical exercise | Dietary supplement | Protein module |
| Vitamin D supplementationCalcifediol supplement administered orally in order to reach sufficiency levels (30 ng/ml) | Combination product | Mediterranean diet, Protein module, Standard hypercaloric hyperproteic Oral supplement |
| Physical exercisePhysical exercise adapted to patients with heart failure (Cardiac rehabilitation) | Combination product | Mediterranean diet, Protein module, Standard hypercaloric hyperproteic Oral supplement |
Primary outcome
Muscle mass
Time frame: 6 months
Changes in muscle mass
Functionality
Time frame: 6 months
Changes in functionality determined by the up and go test
2 secondary outcomes
Albumin
Time frame: 6 months
C-RP
Time frame: 6 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 6 May 2025.
- Individual participant dataSharing planned: Undecided
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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 Mediterranean diet, Hypercaloric, hyperproteic oral nutritional supplement and Protein module in people with Sarcopenia, run by Maimónides Biomedical Research Institute of Córdoba 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 4 inclusion and 2 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 6 May 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. 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?
Muscle mass (time frame: 6 months). The study lists 2 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 6 May 2025.