SarcopeniaNCT04073693
Characterization of the Nutritional Status in the Patient With Liver Cirrhosis
A study testing Branched chain amino acids (BRCA) in people with Sarcopenia, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial summary
In the subgroup of patients with sarcopenia, regardless of their body mass index, we want to verify the real impact of nutritional supplements with branched chain amino acids on the standard treatment based on nutritional intervention and physical exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Branched chain amino acids (BRCA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2017to 9 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic patients with sarcopenia in abdominal CT.
Who cannot join
- chronic renal failure or being on hemodialysis
- active hepatitis B or C virus infection
- active alcohol abuse
- coinfection with human immunodeficiency virus
- renal or previous liver transplantation
- history of neoplasia requiring chemotherapy or radiotherapy
Show all 9Show fewer
- hepatocellular carcinoma outside of Milan criteria
- TIPs
- unwillingness to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of the Nutritional Status in the Patient With Liver Cirrhosis and Impact of a Nutritional Intervention With Nutritional Supplements With BRCA vs. Standard Treatment in the Subgroup of Patients With Sarcopenia
In the subgroup of patients with sarcopenia, regardless of their body mass index, we want to verify the real impact of nutritional supplements with branched chain amino acids on the standard treatment based on nutritional intervention and physical exercise.
- Conditions
- Sarcopenia
- Being tested
- Branched chain amino acids (BRCA)
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branched chain amino acids (BRCA)Dietary supplement
They were with BRCA during the day apart of following the standard recommendations
| Study group | Role | What they receive |
|---|---|---|
| BRCA | Active comparator | They were in treatment with BRCA and standard treatment based on nutritional intervention and physical exercise. Receives: Dietary Supplement: Branched chain amino acids (BRCA) |
| Placebo | Placebo comparator | They only were on standard treatment based on nutritional intervention and physical exercise. Receives: Dietary Supplement: Branched chain amino acids (BRCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of muscle mass in patients with sarcopenia
To assess whether to add to dietary and physical activity recommendations, nutritional supplements with BRCA under usual clinical conditions can lead to a greater change of muscle mass in patients with sarcopenia
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 posted29 Aug 2019
- Study start1 Aug 2017
- Primary completion1 Aug 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Luis Calleja, Puerta de Hierro University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073693
- Sponsor's protocol ID
- 11.17
- Status last verified
- Aug 2019
- First submitted
- 9 Aug 2019
- Last updated
- 29 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hernandez-Conde M, Llop E, Gomez-Pimpollo L, Fernandez Carrillo C, Rodriguez L, Van Den Brule E, Perello C, Lopez-Gomez M, Abad J, Martinez-Porras JL, Fernandez-Puga N, Ferre C, Trapero M, Fraga E, Calleja JL. Adding Branched-Chain Amino Acids to an Enhanced Standard-of-Care Treatment Improves Muscle Mass of Cirrhotic Patients With Sarcopenia: A Placebo-Controlled Trial. Am J Gastroenterol. 2021 Nov 1;116(11):2241-2249. doi: 10.14309/ajg.0000000000001301.
PubMed 34074812
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Nutritional Status in the Patient With Liver Cirrhosis and Impact of a Nutritional Intervention With Nutritional Supplements With BRCA vs. Standard Treatment in the Subgroup of Patients With Sarcopenia
- ClinicalTrials.gov ID
- NCT04073693
- Acronym / sponsor ID
- 11.17
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 29 Aug 2019 (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.
In the subgroup of patients with sarcopenia, regardless of their body mass index, we want to verify the real impact of nutritional supplements with branched chain amino acids on the standard treatment based on nutritional intervention and physical exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRCA | Active comparator | Dietary Supplement: Branched chain amino acids (BRCA)They were in treatment with BRCA and standard treatment based on nutritional intervention and physical exercise. |
| Placebo | Placebo comparator | Dietary Supplement: Branched chain amino acids (BRCA)They only were on standard treatment based on nutritional intervention 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 (1 listed)
- Cirrhotic patients with sarcopenia in abdominal CT.
Key exclusion criteria (9 listed)
- chronic renal failure or being on hemodialysis
- active hepatitis B or C virus infection
- active alcohol abuse
- coinfection with human immunodeficiency virus
- renal or previous liver transplantation
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 |
|---|---|---|
| Branched chain amino acids (BRCA)They were with BRCA during the day apart of following the standard recommendations | Dietary supplement | BRCA, Placebo |
Primary outcome
Change of muscle mass in patients with sarcopenia
Time frame: 12 weeks
To assess whether to add to dietary and physical activity recommendations, nutritional supplements with BRCA under usual clinical conditions can lead to a greater change of muscle mass in patients with sarcopenia
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 29 Aug 2019.
- Derived from this study: PubMed 34074812Hernandez-Conde M, Llop E, Gomez-Pimpollo L, Fernandez Carrillo C, Rodriguez L, Van Den Brule E, Perello C, Lopez-Gomez M, Abad J, Martinez-Porras JL, Fernandez-Puga N, Ferre C, Trapero M, Fraga E, Calleja JL. Adding Branched-Chain Amino Acids to an Enhanced Standard-of-Care Treatment Improves Muscle Mass of Cirrhotic Patients With Sarcopenia: A Placebo-Controlled Trial. Am J Gastroenterol. 2021 Nov 1;116(11):2241-2249. doi: 10.14309/ajg.0000000000001301.
- 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 Branched chain amino acids (BRCA) in people with Sarcopenia, run by Puerta de Hierro University Hospital 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 9 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 29 Aug 2019. 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?
Change of muscle mass in patients with sarcopenia (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04073693, which also lists 1 linked publication.
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 29 Aug 2019.