SarcopeniaNCT05848960
Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia
A study testing Hypercaloric, hyperproteic oral supplement and Mediterranean diet in people with Sarcopenia, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Heart failure (HF) is a chronic disease with an increasing incidence; it represents the final stage of multiple cardiac diseases and significantly affects the QoL of the patients. Its prevalence is about 26 million people in the world, especially in elderly. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Hypercaloric, hyperproteic oral supplement and Mediterranean diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2021to 30 Jul 2023
- 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 18 to 90 years
- 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 Support With Mediterranean Diet and Hyper Caloric, Hyperproteic Oral Supplements in Heart Failure Sarcopenia
Heart failure (HF) is a chronic disease with an increasing incidence; it represents the final stage of multiple cardiac diseases and significantly affects the QoL of the patients. Its prevalence is about 26 million people in the world, especially in elderly. Sarcopenia has been directly associated with the presence of increased comorbidity in patients with HF. In this study the investigators aim to compare the clinical evolution of patients with HF after receiving nutritional support with Mediterranean diet alone or in combination with a hypercaloric, hyperproteic oral nutritional Supplement
Read the detailed description
All participants will receive general counseling, education about MedDiet and vitamin D supplementation in order to reach levels of sufficiency (25OH vitamin D>30 ng/dL) for avoiding confounding results. Participants (n=50) will be randomly allocated to MedDiet or MedDiet plus hypercaloric, hyperproteic standard oral nutritional supplement (ONS), 2 ONS per da). Participants will be evaluated at baseline, 12 and 24 weeks after nutritional support
- Conditions
- Sarcopenia
- Being tested
- Hypercaloric, hyperproteic oral supplement, Mediterranean diet
- Keywords
- Heart failure, Sarcopenia, Nutritional support
- Medical subject headings
- Sarcopenia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypercaloric, hyperproteic oral supplementDietary supplement
2 supplements per day
Mediterranean dietOther
Mediterranean diet
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet | Active comparator | Mediterranean diet Receives: Other: Mediterranean diet |
| Mediterranean diet plus hypercaloric, hyperproteic oral supplement | Experimental | Mediterranean diet plus hypercaloric, hyperproteic oral supplement Receives: Dietary Supplement: Hypercaloric, hyperproteic oral supplement; Other: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Changes in percent of muscle mass
Measured: 6 months
Left ventricular ejection fraction
Changes in left ventricular ejection fraction
Measured: 6 months
Secondary outcomes (7)
pro-BNP
Changes in pro-BNP
Measured: 6 months
Fat mass
Changes in fat mass using bioimpedance and echography
Measured: 6 months
Phase angle
Changes in phase angle using bioimpedance
Measured: 6 months
Albumin
Changes in serum albumin levels (g/l)
Measured: 6 months
Preallbumin
Changes in serum prealbumin levels (mg/dl)
Measured: 6 months
Transferrin
Changes in serum transferrin levels (mg/dl)
Measured: 6 months
CRP
Changes in CRP levels (g/l)
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 posted8 May 2023
- Study start1 Jul 2021
- Primary completion1 Jul 2023
- Study completion30 Jul 2023
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
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
- NCT05848960
- Sponsor's protocol ID
- Heart failure sarcopenia 1
- Status last verified
- May 2025
- First submitted
- 17 Apr 2023
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Support With Mediterranean Diet and Hyper Caloric, Hyperproteic Oral Supplements in Heart Failure Sarcopenia
- ClinicalTrials.gov ID
- NCT05848960
- Acronym / sponsor ID
- Heart failure sarcopenia 1
- Conditions
- Sarcopenia
- Keywords
- Heart failure, Sarcopenia, Nutritional support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 8 May 2023 (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.
Heart failure (HF) is a chronic disease with an increasing incidence; it represents the final stage of multiple cardiac diseases and significantly affects the QoL of the patients. Its prevalence is about 26 million people in the world, especially in elderly. Sarcopenia has been directly associated with the presence of increased comorbidity in patients with HF. In this study the investigators aim to compare the clinical evolution of patients with HF after receiving nutritional support with Mediterranean diet alone or in combination with a hypercaloric, hyperproteic oral nutritional Supplement
Detailed description
All participants will receive general counseling, education about MedDiet and vitamin D supplementation in order to reach levels of sufficiency (25OH vitamin D>30 ng/dL) for avoiding confounding results. Participants (n=50) will be randomly allocated to MedDiet or MedDiet plus hypercaloric, hyperproteic standard oral nutritional supplement (ONS), 2 ONS per da). Participants will be evaluated at baseline, 12 and 24 weeks after nutritional support
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet | Active comparator | Other: Mediterranean dietMediterranean diet |
| Mediterranean diet plus hypercaloric, hyperproteic oral supplement | Experimental | Dietary Supplement: Hypercaloric, hyperproteic oral supplement, Other: Mediterranean dietMediterranean diet plus hypercaloric, hyperproteic oral supplement |
Who may qualify
- Ages
- 18 to 90 years
- 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 |
|---|---|---|
| Hypercaloric, hyperproteic oral supplement2 supplements per day | Dietary supplement | Mediterranean diet plus hypercaloric, hyperproteic oral supplement |
| Mediterranean dietMediterranean diet | Other | Mediterranean diet, Mediterranean diet plus hypercaloric, hyperproteic oral supplement |
Primary outcome
Muscle mass
Time frame: 6 months
Changes in percent of muscle mass
Left ventricular ejection fraction
Time frame: 6 months
Changes in left ventricular ejection fraction
7 secondary outcomes
pro-BNP
Time frame: 6 months
Fat mass
Time frame: 6 months
Phase angle
Time frame: 6 months
Albumin
Time frame: 6 months
Preallbumin
Time frame: 6 months
Transferrin
Time frame: 6 months
CRP
Time frame: 6 months
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 6 May 2025.
- Individual participant dataSharing planned: No
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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 Hypercaloric, hyperproteic oral supplement and Mediterranean diet 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: finished, 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?
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?
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.