Endothelial DysfunctionLFN-NABNCT04041115
Effect of Non-alcoholic Beer in Cirrhosis
A study testing Non-alcoholic beer in people with Endothelial Dysfunction and Nutritional Status, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Trial summary
The implementation of nutritional strategies targeting several variables at once could benefit patients with cirrhosis. Non-alcoholic beer has different compounds derived from hops that exert antioxidant, anti-inflammatory and nutritional properties. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Endothelial Dysfunction, Nutritional Status, Quality of Life
- What is being tested?
- Non-alcoholic beer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to 15 Aug 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver Cirrhosis of any aetiology (liver biopsy or a combination of clinical and biochemical variables plus evidence of portal hypertension); without decompensation during the past month; serum creatinine <1.5 mg%; able to attend the appointed visits and willing to participate in the study.
Who cannot join
- Severe concomitant cardiopulmonary diseases; decompensated type 2 Diabetes Mellitus, insulin use or proliferative diabetic retinopathy; orthopedic or osteomuscular limitations; any type of cancer; primary sclerosing cholangitis and inflammatory bowel disease.
About this study
Official title: Effect of a Multifactorial Intervention (Non-alcoholic Beer, Diet and Exercise) on Endothelial Function, Nutritional Status and Quality of Life in Patients With Cirrhosis
The implementation of nutritional strategies targeting several variables at once could benefit patients with cirrhosis. Non-alcoholic beer has different compounds derived from hops that exert antioxidant, anti-inflammatory and nutritional properties. The aim of this study is to evaluate the effect of diet + exercise and non-alcoholic beer on nutritional status, endothelial function and quality of life in patients with cirrhosis.
- Conditions
- Endothelial Dysfunction, Nutritional Status, Quality of Life
- Being tested
- Non-alcoholic beer, control
- Keywords
- cirrhosis, nutrition, sarcopenia, non-alcoholic beer
- Medical subject headings
- Fibrosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-alcoholic beerDietary supplement
Treatment consisted of 330ml non-alcoholic beer per day, plus an individualized dietary program and an exercise program with a pedometer-based bracelet to reach at least 5000 steps/day during 2 + 8 weeks.
controlOther
Treatment consisted of 330ml of water, plus an individualized dietary program and an exercise program with a pedometer-based bracelet to reach at least 5000 steps/day during 2 + 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | personalized nutritional therapy + aerobic exercise Receives: Other: control |
| Non-alcoholic Beer | Active comparator | non-alcoholic beer + personalized nutritional therapy + aerobic exercise Receives: Dietary Supplement: Non-alcoholic beer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
improvement in impedance-derived phase angle (PhA)
Measured: 8 weeks
Endothelial function
improvement in flow-mediated dilation (brachial artery)
Measured: 8 weeks
Endothelial dysfunction
improvement in serum markers of endothelial function (v.gr. nitric oxide, NO; prostacyclin, PGI2, etc.)
Measured: 8 weeks
Quality of life questionnaire
Improvement in quality of life questionnaire CLDQ (chronic liver disease questionnaire)
Measured: 8 weeks
Changes in the heterogeneity of gut Microbiota
Changes in the heterogeneity of fecal microbiota in terms of bacterial diversity will be assessed
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study startJan 2016
- Primary completionDec 2018
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo U. Macías-Rodríguez, M.D., Ph.D., Study director, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041115
- Sponsor's protocol ID
- MICTLAN-2
- Acronym
- LFN-NAB
- Status last verified
- Mar 2019
- First submitted
- 26 Apr 2019
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multifactorial Intervention (Non-alcoholic Beer, Diet and Exercise) on Endothelial Function, Nutritional Status and Quality of Life in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT04041115
- Acronym / sponsor ID
- LFN-NAB / MICTLAN-2
- Conditions
- Endothelial Dysfunction, Nutritional Status, Quality of Life
- Keywords
- cirrhosis, nutrition, sarcopenia, non-alcoholic beer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 1 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.
The implementation of nutritional strategies targeting several variables at once could benefit patients with cirrhosis. Non-alcoholic beer has different compounds derived from hops that exert antioxidant, anti-inflammatory and nutritional properties. The aim of this study is to evaluate the effect of diet + exercise and non-alcoholic beer on nutritional status, endothelial function and quality of life in patients with cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: controlpersonalized nutritional therapy + aerobic exercise |
| Non-alcoholic Beer | Active comparator | Dietary Supplement: Non-alcoholic beernon-alcoholic beer + personalized nutritional therapy + aerobic exercise |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Liver Cirrhosis of any aetiology (liver biopsy or a combination of clinical and biochemical variables plus evidence of portal hypertension); without decompensation during the past month; serum creatinine <1.5 mg%; able to attend the appointed visits and willing to participate in the study.
Key exclusion criteria (1 listed)
- Severe concomitant cardiopulmonary diseases; decompensated type 2 Diabetes Mellitus, insulin use or proliferative diabetic retinopathy; orthopedic or osteomuscular limitations; any type of cancer; primary sclerosing cholangitis and inflammatory bowel 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 |
|---|---|---|
| Non-alcoholic beerTreatment consisted of 330ml non-alcoholic beer per day, plus an individualized dietary program and an exercise program with a pedometer-based bracelet to reach at least 5000 steps/day during 2 + 8 weeks. | Dietary supplement | Non-alcoholic Beer |
| controlTreatment consisted of 330ml of water, plus an individualized dietary program and an exercise program with a pedometer-based bracelet to reach at least 5000 steps/day during 2 + 8 weeks. | Other | Control |
Primary outcome
Nutritional status
Time frame: 8 weeks
improvement in impedance-derived phase angle (PhA)
Endothelial function
Time frame: 8 weeks
improvement in flow-mediated dilation (brachial artery)
Endothelial dysfunction
Time frame: 8 weeks
improvement in serum markers of endothelial function (v.gr. nitric oxide, NO; prostacyclin, PGI2, etc.)
Quality of life questionnaire
Time frame: 8 weeks
Improvement in quality of life questionnaire CLDQ (chronic liver disease questionnaire)
Changes in the heterogeneity of gut Microbiota
Time frame: 8 weeks
Changes in the heterogeneity of fecal microbiota in terms of bacterial diversity will be assessed
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 1 Sep 2022.
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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.
Ricardo U. Macías-Rodríguez, M.D., Ph.D. study director
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Questions about this trial
What is this clinical trial studying?
A study testing Non-alcoholic beer in people with Endothelial Dysfunction and Nutritional Status, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
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 1 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 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Nutritional status (time frame: 8 weeks). The study lists 5 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 1 Sep 2022.