Heart FailureNCT07731048
High-Protein Diet and HMB Supplementation in Patients With Heart Failure
A study testing β-Hydroxy-β-Methylbutyrate (HMB) and Individualized Dietary Counseling in people with Heart Failure, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to evaluate the effects of a high-protein diet with or without HMB supplementation compared with a normoprotein diet on clinical, nutritional, and functional outcomes in patients with heart failure. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- β-Hydroxy-β-Methylbutyrate (HMB) and Individualized Dietary Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2026to 30 Nov 2027
- 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
- Adults aged 18 years or older;
- Male or female;
- Diagnosis of chronic heart failure for at least 3 months, established according to the Brazilian Guidelines for Chronic and Acute Heart Failure and confirmed by medical records.
Who cannot join
- Chronic kidney disease stage 3b or higher;
- Listed for heart transplantation;
- Hospitalization for decompensated heart failure within the previous 3 months;
- Active cancer treatment or cancer treatment within the previous 5 years;
- History of alcohol or illicit drug abuse within the previous 12 months;
- Chronic use of anti-inflammatory drugs, anticonvulsants, corticosteroids, or immunosuppressive agents;
Show all 10Show fewer
- Pregnancy or breastfeeding;
- Wheelchair use preventing anthropometric assessment;
- Current use of protein supplements;
- Participation in another randomized clinical trial with interventions that may interfere with the primary outcome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital de Clínicas de Porto Alegre (Clinical Research Center)
Porto Alegre, Rio Grande do Sul
Ingrid S Knobloch, PhD Canditate, +55 51 3359 6275, iknobloch@hcpa.edu.br
About this study
Official title: Effect of a High-Protein Diet and β-Hydroxy-β-Methylbutyrate Supplementation in Comparison to a Normo-protein Diet on Muscle Mass, Strength, and Physical Function in Patients With Heart Failure: Protocol of a Three-Arm, Parallel-Group, Superiority Randomized Clinical Trial
The goal of this clinical trial is to evaluate the effects of a high-protein diet with or without HMB supplementation compared with a normoprotein diet on clinical, nutritional, and functional outcomes in patients with heart failure. The main questions it aims to answer are:
- Does a normocaloric high-protein diet improve muscle mass, muscle strength, and physical function compared with a normocaloric normoprotein diet after 8 weeks?
- Does adding 3 g/day of β-hydroxy-β-methylbutyrate (HMB) to a normocaloric high-protein diet provide additional benefits for muscle mass, muscle strength, and physical function compared with a normocaloric high-protein diet alone?
- Do these nutritional interventions improve renal function, inflammatory and clinical biomarkers, functional status, and quality of life after 8 weeks?
Read more
Researchers will compare three groups (normocaloric normoprotein diet, normocaloric high-protein diet, and normocaloric high-protein diet plus HMB supplementation) to determine the effects of these interventions on clinical, nutritional, and functional outcomes.
Participants will:
- Be randomly assigned to one of the three study groups
- Receive individualized dietary counseling according to their assigned intervention
- Receive one study sachet daily containing either an HMB-enriched nutritional supplement (providing 3 g/day of HMB) or a matched placebo, according to the assigned study group
- Undergo assessments of muscle mass, muscle strength, physical function, renal function, inflammatory and clinical biomarkers, and quality of life at baseline, 4 weeks, and 8 weeks
- Conditions
- Heart Failure
- Being tested
- β-Hydroxy-β-Methylbutyrate (HMB), Placebo, Individualized Dietary Counseling
- Keywords
- High-Protein Diet, β-Hydroxy-β-Methylbutyrate, Muscle Mass, Muscle Strength, Physical Function, Dietary Intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β-Hydroxy-β-Methylbutyrate (HMB)Dietary supplement
Participants will receive one daily sachet of a powdered nutritional supplement enriched with 3 g of β-hydroxy-β-methylbutyrate (HMB) for 8 weeks. The supplement will be dissolved in water and consumed once daily.
PlaceboDietary supplement
Participants will receive one daily placebo sachet identical in appearance, flavor, and packaging to the HMB supplement for 8 weeks
Individualized Dietary CounselingBehavioural
Participants will receive individualized dietary counseling from a registered dietitian. Energy intake will be prescribed at 20-30 kcal/kg/day to maintain body weight. According to randomization, participants will receive either a normoprotein diet (1.0 g protein/kg/day) or a high-protein diet (1.5 g protein/kg/day), based on the DASH dietary pattern and the Brazilian Dietary Guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Normocaloric Normal-Protein Diet (NCNP) | Active comparator | Participants will receive an individualized normocaloric normoprotein diet providing 1.0 g protein/kg/day, 55% of total energy from carbohydrates, and 30% from lipids for 8 weeks. Energy intake (20-30 kcal/kg/day) will be individualized to maintain body weight. Dietary counseling will be based on the DASH dietary pattern and the Brazilian Dietary Guidelines. Participants will also receive one daily placebo sachet. Receives: Dietary Supplement: Placebo; Behavioral: Individualized Dietary Counseling |
| Normocaloric High-Protein Diet (NCHP) | Experimental | Participants will receive an individualized normocaloric high-protein diet providing 1.5 g protein/kg/day, 50% of total energy from carbohydrates, and 30% from lipids for 8 weeks. Energy intake (20-30 kcal/kg/day) will be individualized to maintain body weight. Dietary counseling will be based on the DASH dietary pattern and the Brazilian Dietary Guidelines. Participants will also receive one daily placebo sachet. Receives: Dietary Supplement: Placebo; Behavioral: Individualized Dietary Counseling |
| Normocaloric High-Protein Diet + HMB (NCHP+HMB) | Experimental | Participants will receive an individualized normocaloric high-protein diet providing 1.5 g protein/kg/day, 50% of total energy from carbohydrates, and 30% from lipids for 8 weeks. Energy intake (20-30 kcal/kg/day) will be individualized to maintain body weight. Dietary counseling will be based on the DASH dietary pattern and the Brazilian Dietary Guidelines. Participants will also receive one daily HMB-enriched nutritional supplement providing 3 g/day of β-hydroxy-β-methylbutyrate (HMB). Receives: Dietary Supplement: β-Hydroxy-β-Methylbutyrate (HMB); Behavioral: Individualized Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Muscle Mass
Muscle mass will be assessed using complementary anthropometric measurements, bioelectrical impedance analysis (BIA), and muscle ultrasound. Anthropometric assessment will include mid-upper arm circumference, mid-arm muscle circumference, calf circumference, and adductor pollicis muscle thickness. BIA will be used to estimate skeletal muscle mass and skeletal muscle index (SMI). Muscle ultrasound will assess quadriceps muscle thickness, cross-sectional area, echogenicity, pennation angle, and fascicle length. All measurements will be performed by trained assessors using standardized procedures, and established sex-specific cutoffs will be used to classify reduced muscle mass when applicable.
Measured: Baseline, Week 4, and Week 8
Secondary outcomes (7)
Change from Baseline in Muscle strength
Muscle strength will be assessed using handgrip strength for upper-limb strength and the Five Times Sit-to-Stand Test (5STS) for lower-limb strength. Handgrip strength will be measured bilaterally using a Jamar® hydraulic dynamometer. Three measurements will be obtained for each hand, and the highest value will be used for analysis. Established sex-specific cutoffs will be used to classify low muscle strength. Lower-limb strength will be evaluated using the Five Times Sit-to-Stand Test, with test completion time recorded and validated cutoffs used to identify reduced lower-limb muscle strength.
Measured: Baseline, Week 4, and Week 8
Change from Baseline in Physical function
Physical function will be assessed using the Timed Up and Go Test. Participants will be instructed to stand up from a standard chair, walk 3 meters, turn around, return to the chair, and sit down. Reduced physical function will be defined as a completion time ≥ 20 s.
Measured: Baseline, Week 4, and Week 8
Change from Baseline in Renal function
Renal function will be assessed by measuring serum creatinine using a standardized laboratory assay and estimating glomerular filtration rate (eGFR) using the CKD-EPI 2021 creatinine equation. Changes in serum creatinine and eGFR will be used to evaluate the effect of the intervention on renal function.
Measured: Baseline and Week 8
Change from Baseline in High-Sensitivity C-Reactive Protein
Systemic inflammation will be assessed by measuring high-sensitivity C-reactive protein (hs-CRP) using an immunoturbidimetric assay. Changes in hs-CRP concentrations will be used to evaluate the effect of the intervention on systemic inflammation.
Measured: Baseline and Week 8
Change from Baseline in New York Heart Association (NYHA) Functional Class
Functional status will be assessed using the New York Heart Association (NYHA) functional classification. Changes in NYHA functional class will be used to evaluate the effect of the intervention on heart failure severity and functional status.
Measured: Baseline and Week 8
Change from Baseline in B-Type Natriuretic Peptide (BNP)
Heart failure severity will be assessed by measuring B-type natriuretic peptide (BNP) using a standardized immunoassay. Changes in BNP concentrations will be used to evaluate the effect of the intervention on heart failure severity.
Measured: Baseline and Week 8
Change from Baseline in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score
Health-related quality of life will be assessed using the validated Minnesota Living with Heart Failure Questionnaire (MLHFQ), a 21-item disease-specific questionnaire that evaluates the impact of heart failure on physical, emotional, social, and mental aspects of daily life. Total and domain scores will be calculated, with higher scores indicating poorer health-related quality of life. Changes in MLHFQ scores will be used to evaluate the effect of the intervention on health-related quality of life.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriela C Souza, RD, PhD, Principal investigator, Hospital de Clínicas de Porto Alegre (HCPA)Flávia M Silva, RD, PhD, Study chair, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731048
- Sponsor's protocol ID
- 2026-0072
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data underlying the published results will be made available upon reasonable request. Only the data necessary to reproduce the published analyses will be shared, subject to approval by the study investigators and applicable institutional requirements. Data that could compromise participant confidentiality will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a High-Protein Diet and β-Hydroxy-β-Methylbutyrate Supplementation in Comparison to a Normo-protein Diet on Muscle Mass, Strength, and Physical Function in Patients With Heart Failure: Protocol of a Three-Arm, Parallel-Group, Superiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07731048
- Acronym / sponsor ID
- 2026-0072
- Conditions
- Heart Failure
- Keywords
- High-Protein Diet, β-Hydroxy-β-Methylbutyrate, Muscle Mass, Muscle Strength, Physical Function, Dietary Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 28 Jul 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.
The goal of this clinical trial is to evaluate the effects of a high-protein diet with or without HMB supplementation compared with a normoprotein diet on clinical, nutritional, and functional outcomes in patients with heart failure. The main questions it aims to answer are:
- Does a normocaloric high-protein diet improve muscle mass, muscle strength, and physical function compared with a normocaloric normoprotein diet after 8 weeks?
- Does adding 3 g/day of β-hydroxy-β-methylbutyrate (HMB) to a normocaloric high-protein diet provide additional benefits for muscle mass, muscle strength, and physical function compared with a normocaloric high-protein diet alone?
- Do these nutritional interventions improve renal function, inflammatory and clinical biomarkers, functional status, and quality of life after 8 weeks?
Researchers will compare three groups (normocaloric normoprotein diet, normocaloric high-protein diet, and normocaloric high-protein diet plus HMB supplementation) to determine the effects of these interventions on clinical, nutritional, and functional outcomes.
Participants will:
- Be randomly assigned to one of the three study groups
- Receive individualized dietary counseling according to their assigned intervention
- Receive one study sachet daily containing either an HMB-enriched nutritional supplement (providing 3 g/day of HMB) or a matched placebo, according to the assigned study group
- Undergo assessments of muscle mass, muscle strength, physical function, renal function, inflammatory and clinical biomarkers, and quality of life at baseline, 4 weeks, and 8 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normocaloric Normal-Protein Diet (NCNP) | Active comparator | Dietary Supplement: Placebo, Behavioral: Individualized Dietary CounselingParticipants will receive an individualized normocaloric normoprotein diet providing 1.0 g protein/kg/day, 55% of total energy from carbohydrates, and 30% from lipids for 8 weeks. Energy intake (20-30 kcal/kg/day) will be individualized to maintain body weight. Dietary counseling will be based on the DASH dietary pattern and the Brazilian Dietary Guidelines. Participants will also receive one daily placebo sachet. |
| Normocaloric High-Protein Diet (NCHP) | Experimental | Dietary Supplement: Placebo, Behavioral: Individualized Dietary CounselingParticipants will receive an individualized normocaloric high-protein diet providing 1.5 g protein/kg/day, 50% of total energy from carbohydrates, and 30% from lipids for 8 weeks. Energy intake (20-30 kcal/kg/day) will be individualized to maintain body weight. Dietary counseling will be based on the DASH dietary pattern and the Brazilian Dietary Guidelines. Participants will also receive one daily placebo sachet. |
| Normocaloric High-Protein Diet + HMB (NCHP+HMB) | Experimental | Dietary Supplement: β-Hydroxy-β-Methylbutyrate (HMB), Behavioral: Individualized Dietary CounselingParticipants will receive an individualized normocaloric high-protein diet providing 1.5 g protein/kg/day, 50% of total energy from carbohydrates, and 30% from lipids for 8 weeks. Energy intake (20-30 kcal/kg/day) will be individualized to maintain body weight. Dietary counseling will be based on the DASH dietary pattern and the Brazilian Dietary Guidelines. Participants will also receive one daily HMB-enriched nutritional supplement providing 3 g/day of β-hydroxy-β-methylbutyrate (HMB). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older;
- Male or female;
- Diagnosis of chronic heart failure for at least 3 months, established according to the Brazilian Guidelines for Chronic and Acute Heart Failure and confirmed by medical records.
Key exclusion criteria (10 listed)
- Chronic kidney disease stage 3b or higher;
- Listed for heart transplantation;
- Hospitalization for decompensated heart failure within the previous 3 months;
- Active cancer treatment or cancer treatment within the previous 5 years;
- History of alcohol or illicit drug abuse within the previous 12 months;
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 |
|---|---|---|
| β-Hydroxy-β-Methylbutyrate (HMB)Participants will receive one daily sachet of a powdered nutritional supplement enriched with 3 g of β-hydroxy-β-methylbutyrate (HMB) for 8 weeks. The supplement will be dissolved in water and consumed once daily. | Dietary supplement | Normocaloric High-Protein Diet + HMB (NCHP+HMB) |
| PlaceboParticipants will receive one daily placebo sachet identical in appearance, flavor, and packaging to the HMB supplement for 8 weeks | Dietary supplement | Normocaloric High-Protein Diet (NCHP), Normocaloric Normal-Protein Diet (NCNP) |
| Individualized Dietary CounselingParticipants will receive individualized dietary counseling from a registered dietitian. Energy intake will be prescribed at 20-30 kcal/kg/day to maintain body weight. According to randomization, participants will receive either a normoprotein diet (1.0 g protein/kg/day) or a high-protein diet (1.5 g protein/kg/day), based on the DASH dietary pattern and the Brazilian Dietary Guidelines. | Behavioural | Normocaloric High-Protein Diet (NCHP), Normocaloric High-Protein Diet + HMB (NCHP+HMB), Normocaloric Normal-Protein Diet (NCNP) |
Primary outcome
Change from Baseline in Muscle Mass
Time frame: Baseline, Week 4, and Week 8
Muscle mass will be assessed using complementary anthropometric measurements, bioelectrical impedance analysis (BIA), and muscle ultrasound. Anthropometric assessment will include mid-upper arm circumference, mid-arm muscle circumference, calf circumference, and adductor pollicis muscle thickness. BIA will be used to estimate skeletal muscle mass and skeletal muscle index (SMI). Muscle ultrasound will assess quadriceps muscle thickness, cross-sectional area, echogenicity, pennation angle, and fascicle length. All measurements will be performed by trained assessors using standardized procedures, and established sex-specific cutoffs will be used to classify reduced muscle mass when applicable.
7 secondary outcomes
Change from Baseline in Muscle strength
Time frame: Baseline, Week 4, and Week 8
Change from Baseline in Physical function
Time frame: Baseline, Week 4, and Week 8
Change from Baseline in Renal function
Time frame: Baseline and Week 8
Change from Baseline in High-Sensitivity C-Reactive Protein
Time frame: Baseline and Week 8
Change from Baseline in New York Heart Association (NYHA) Functional Class
Time frame: Baseline and Week 8
Change from Baseline in B-Type Natriuretic Peptide (BNP)
Time frame: Baseline and Week 8
Change from Baseline in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score
Time frame: Baseline and Week 8
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 28 Jul 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data underlying the published results will be made available upon reasonable request. Only the data necessary to reproduce the published analyses will be shared, subject to approval by the study investigators and applicable institutional requirements. Data that could compromise participant confidentiality will not be shared.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Gabriela C Souza, RD, PhD principal investigator
Hospital de Clínicas de Porto Alegre (HCPA)
Flávia M Silva, RD, PhD study chair
Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing β-Hydroxy-β-Methylbutyrate (HMB) and Individualized Dietary Counseling in people with Heart Failure, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 28 Jul 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 Brazil. 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?
Contact Ingrid S Knobloch, PhD Candidate (+55 51 3359 6275, iknobloch@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Muscle Mass (time frame: Baseline, Week 4, and Week 8). 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 28 Jul 2026.