Probiotic InterventionPROBILIPNCT05378230
Probiotic Intervention, Bile Acids and Lipid Metabolism Metabolic Profile in Healthy Overweight Subjects.
A study testing Probiotic preparation of three Lactobacillus plantarum strains (CECT 7527, CECT 7528, CECT 7529) in people with Probiotic Intervention, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Moderate hypercholesterolemia, metabolic alterations derived from overweight or obesity, and consequently and their related cardiovascular risks can be reduced through changes in lifestyle. A growing body of evidence shows a relationship between hypercholesterolemia and dysfunction of the gut microbiota. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Probiotic Intervention
- What is being tested?
- Probiotic preparation of three Lactobacillus plantarum strains (CECT 7527, CECT 7528, CECT 7529)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 21 Feb 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass index (BMI): Between 25 and 30 Kg / m2
Who cannot join
- Eating disorders.
- Subjects with cardiovascular risk factors such as hypercholesterolemia (genetic or secondary), hypertension and diabetes, treated pharmacologically.
- History of ischemic heart disease (and / or previous angina or AMI) or arrhythmia (current or previous).
- Previous strokes and / or peripheral vascular disease.
- Alcohol consumption greater than 60 gr / day.
- Kidney failure (creatinine> 2 mg / dl).
Show all 13Show fewer
- Presence of neoplasia.
- Presence of systemic disease.
- Psychiatric illness under treatment with psychotropics.
- Unstabilized thyroid disease.
- Having followed or being following a hypocaloric diet or regularly consumed dietary supplements for weight or constipation or cholesterol control (plant sterols, soy lecithin, omega-3 fatty acids) for 2 months prior to inclusion in the study.
- Pregnancy or breastfeeding.
- In current treatment with non-steroidal anti-inflammatory drugs, antiplatelet agents, fibrates or statins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Probiotic AB-LIFE on the Amount and Profile of Bile Acids, and the Lipid and Metabolic Profile in Healthy Overweight Subjects.
Moderate hypercholesterolemia, metabolic alterations derived from overweight or obesity, and consequently and their related cardiovascular risks can be reduced through changes in lifestyle. A growing body of evidence shows a relationship between hypercholesterolemia and dysfunction of the gut microbiota.
Gut microbiota is considered a keystone in maintaining the health condition of the host through multiple mechanisms affecting different metabolic processes, including lipid metabolism and cholesterol-related pathways. Bile acids (BA) are cholesterol-derived compounds synthesized in the liver and metabolized upon modification by gut bacteria once they reach the colon.
Read more
Conversely, BAs shape the composition and function of the intestinal microbiota. This mutual interplay between BAs and gut microbiota regulates many physiological processes, including the lipid, carbohydrate and energy metabolism of the host.
Previous studies based on Lactobacillus plantarum have shown 3 strains CECT 7527, 7528, and 7529 with the ability to adhere to the intestinal mucosa with very low toxicity, what makes them susceptible to be used as a probiotic. The lipid-lowering effect of the 3 bacteria strains was already evidenced in previous preclinical studies in animal models and clinical studies in hypercholesterolemic subjects. Up to now, however, little is known about the effects of the 3- combined Lactobacillus plantarum strains on levels and profile of bile acids in healthy overweight subjects, otherwise at low cardiovascular risk.
The aim of this study is to explore on the mechanism of action of a Lactobacillus plantarum mixture (CECT 7527, CECT 7528 and CECT 7529) and evaluate the effect of this probiotic formulation on BA profile as well as on plasma lipids and other related biomarkers when administered in a dose-dependent regime in a cohort of overweight subjects.
The probiotic product was administrated for 4 weeks with a weekly dose-regime of 2x, 3x, and 4x, respectively, in the second, third, and fourth week in relation to the first week. The effects were evaluated on: (1) level and profile of bile acids in plasma and feces, (2) plasma lipid/lipoprotein and fatty acid profile and (3) endocrine hormones, glucose metabolism and inflammatory markers in plasma.
Read the detailed description
Sample size (N=20) was calculated according results of previous studies on plasma bile acids. The study refers to healthy overweight [body mass index (BMI) 25.0-29.9 kg/m2] adult men (N=10) and women (N=10) between the ages of 25 and 60 years.
The study was approved by the Human Ethical Review Committee of the Hospital Sant Pau in Barcelona (register number: 20/029). Informed written consent was obtained from all participants before their inclusion in the study. To confirm health status, all subjects underwent a complete physical examination conducted by the study physician.
The study lasted 6 weeks that were structured in:
- 2 weeks of run-in.
- 4 weeks of intervention period divided into 4 phases of 7 days. During the intervention period, Lactobacillus plantarum capsules were consumed according to the following pattern:
- Days 0-6: 1 capsule/day
- Days 7-13: 2 capsules/day
- Days 14-20: 3 capsules/day
- Days 21-27: 4 capsules/day
The volunteers visited the center at the beginning of each phase of the intervention period (Days 0, 7, 14 and 21) and at the end of the intervention period (Day 28).
Dietary habits were collected. Compliance was monitored by weekly telephone contact with participants and interviewing them at the end of each intervention period. Blood samples were collected early at the morning after twelve-hour fasting at baseline and at the end of each intervention phase. Blood samples were used for determining all variables of the study. Stool samples were obtained at baseline and after 28 days intervention for the study of bile acids, fatty acids and microbiota.
- Conditions
- Probiotic Intervention
- Being tested
- Probiotic preparation of three Lactobacillus plantarum strains (CECT 7527, CECT 7528, CECT 7529)
- Keywords
- Microbiota, Bile acids, Lipids, Inflammation, Metabolism
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic preparation of three Lactobacillus plantarum strains (CECT 7527, CECT 7528, CECT 7529)Dietary supplement
Also called AB-LIFE
All subjects were submitted to 4 weeks intervention consisting on a dose-dependent regime of Lactobacillus plantarum AB-B (strains CECT 7527, CECT 7528, CECT 7529; AB-LIFE). Before starting the intervention period, all subjects were submitted to a 2-weeks run-in period. During the wash-in and intervention-periods, participants were instructed to maintain their habitual dietary habits and to continue their normal pattern of physical activity throughout the study period.
Treatments during the intervention period were: Week 1: 1 capsule/day taken during breakfast; Week 2: 2 capsules / day at- breakfast; Week 3: 2 capsules at breakfast and 1 at dinner; Week 4: 2capsules at breakfast and 2 capsules at dinner. Each capsule contains 1.2x10^9 cfu (colony forming units) in a 1: 1: 1 ratio of the three strains.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic mixture | Experimental | Arm that received Lactobacillus plantarum mixture (CECT 7527, CECT 7528 and CECT 7529) Receives: Dietary Supplement: Probiotic preparation of three Lactobacillus plantarum strains (CECT 7527, CECT 7528, CECT 7529) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Lipid profile at 7 days
By standardized biochemical techniques
Measured: At days 0 and 7
Change from Baseline Lipid profile at 14 days
By standardized biochemical techniques
Measured: At days 0 and 14
Change from Baseline Lipid profile at 21 days
By standardized biochemical techniques
Measured: At days 0 and 21
Change from Baseline Lipid profile at 28 days
By standardized biochemical techniques
Measured: At days 0 and 28
Change from Baseline Serum bile acids at 14 days
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Measured: At days 0 and 14
Change from Baseline Serum bile acids at 28 days
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Measured: At days 0 and 28
Change from Faecal bile acids at 28 days
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Measured: At days 0 and 28
Change from Baseline Serum fatty acids at 14 days
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Measured: At days 0 and 14
Change from Baseline Serum fatty acids at 28 days
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Measured: At days 0 and 28
Change from Baseline Faecal fatty acids at 28 days
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Measured: At days 0 and 28
Change from Baseline Serum lipoprotein profile at 14 days
By nuclear magnetic resonance (NMR)
Measured: At days 0 and 14
Change from Baseline Serum lipoprotein profile at 28 days
By nuclear magnetic resonance (NMR)
Measured: At days 0 and 28
Change from Baseline Plasmatic endocrine hormones and metabolic markers at 14 days
By Enzyme-Linked immunosorbent Assay (ELISAs)
Measured: At days 0 and 14
Change from Baseline Plasmatic endocrine hormones and metabolic markers at 28 days
By Enzyme-Linked immunosorbent Assay (ELISAs)
Measured: At days 0 and 28
Secondary outcomes (6)
Change from Baseline Plasmatic Inflammatory markers at 14 days
By standardized biochemical techniques and Multiplex for Luminex Immunoassays
Measured: At days 0 and 14
Change from Baseline Plasmatic Inflammatory markers at 28 days
By standardized biochemical techniques and Multiplex for Luminex Immunoassays
Measured: At days 0 and 28
Change from Baseline LDL susceptibility to oxidation and HDL antioxidant capacity at 14 days
By conjugated dienes measurement and by Total radical-trapping antioxidant potential (TRAP) respectively
Measured: At days 0 and 14
Change from Baseline LDL susceptibility to oxidation and HDL antioxidant capacity at 28 days
By conjugated dienes measurement and by Total radical-trapping antioxidant potential (TRAP) respectively
Measured: At days 0 and 28
Change from Baseline Serum Vitamin D and thyroid hormones (TSH, T3 & T4) at 14 days
By Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) and by chemoluminescence immunoassays respectively
Measured: At days 0 and 14
Change from Baseline Serum Vitamin D and thyroid hormones (TSH, T3 & T4) at 28 days
By Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) and by chemoluminescence immunoassays respectively
Measured: At days 0 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Sep 2020
- Primary completion28 Nov 2020
- Study completion21 Feb 2022
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 Probiotic InterventionStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention trial consisted of a single-center, one-arm study with a total duration of 8 weeks, which includes 2-weeks run-in period, 4 week intervention period and 2-weeks post-intervention or wash-out period. The intervention period was divided in 4 periods of 7 days each and the treatment consisted of increasing dose of Lactobacillus plantarum AB-B (CECT 7527, CECT 7528, CECT 7529).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AB Biotics, SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378230
- Sponsor's protocol ID
- IIBSP-PRO-2019-122
- Acronym
- PROBILIP
- Status last verified
- Jun 2022
- First submitted
- 5 May 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Padro T, Santisteban V, Huedo P, Puntes M, Aguilo M, Espadaler-Mazo J, Badimon L. Lactiplantibacillus plantarum strains KABP011, KABP012, and KABP013 modulate bile acids and cholesterol metabolism in humans. Cardiovasc Res. 2024 May 29;120(7):708-722. doi: 10.1093/cvr/cvae061.
PubMed 38525555
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Probiotic AB-LIFE on the Amount and Profile of Bile Acids, and the Lipid and Metabolic Profile in Healthy Overweight Subjects.
- ClinicalTrials.gov ID
- NCT05378230
- Acronym / sponsor ID
- PROBILIP / IIBSP-PRO-2019-122
- Conditions
- Probiotic Intervention
- Keywords
- Microbiota, Bile acids, Lipids, Inflammation, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- AB Biotics, SA
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 Nov 2020 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 18 May 2022 (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.
Moderate hypercholesterolemia, metabolic alterations derived from overweight or obesity, and consequently and their related cardiovascular risks can be reduced through changes in lifestyle. A growing body of evidence shows a relationship between hypercholesterolemia and dysfunction of the gut microbiota.
Gut microbiota is considered a keystone in maintaining the health condition of the host through multiple mechanisms affecting different metabolic processes, including lipid metabolism and cholesterol-related pathways. Bile acids (BA) are cholesterol-derived compounds synthesized in the liver and metabolized upon modification by gut bacteria once they reach the colon.
Conversely, BAs shape the composition and function of the intestinal microbiota. This mutual interplay between BAs and gut microbiota regulates many physiological processes, including the lipid, carbohydrate and energy metabolism of the host.
Previous studies based on Lactobacillus plantarum have shown 3 strains CECT 7527, 7528, and 7529 with the ability to adhere to the intestinal mucosa with very low toxicity, what makes them susceptible to be used as a probiotic. The lipid-lowering effect of the 3 bacteria strains was already evidenced in previous preclinical studies in animal models and clinical studies in hypercholesterolemic subjects. Up to now, however, little is known about the effects of the 3- combined Lactobacillus plantarum strains on levels and profile of bile acids in healthy overweight subjects, otherwise at low cardiovascular risk.
The aim of this study is to explore on the mechanism of action of a Lactobacillus plantarum mixture (CECT 7527, CECT 7528 and CECT 7529) and evaluate the effect of this probiotic formulation on BA profile as well as on plasma lipids and other related biomarkers when administered in a dose-dependent regime in a cohort of overweight subjects.
The probiotic product was administrated for 4 weeks with a weekly dose-regime of 2x, 3x, and 4x, respectively, in the second, third, and fourth week in relation to the first week. The effects were evaluated on: (1) level and profile of bile acids in plasma and feces, (2) plasma lipid/lipoprotein and fatty acid profile and (3) endocrine hormones, glucose metabolism and inflammatory markers in plasma.
Detailed description
Sample size (N=20) was calculated according results of previous studies on plasma bile acids. The study refers to healthy overweight [body mass index (BMI) 25.0-29.9 kg/m2] adult men (N=10) and women (N=10) between the ages of 25 and 60 years.
The study was approved by the Human Ethical Review Committee of the Hospital Sant Pau in Barcelona (register number: 20/029). Informed written consent was obtained from all participants before their inclusion in the study. To confirm health status, all subjects underwent a complete physical examination conducted by the study physician.
The study lasted 6 weeks that were structured in:
- 2 weeks of run-in.
- 4 weeks of intervention period divided into 4 phases of 7 days. During the intervention period, Lactobacillus plantarum capsules were consumed according to the following pattern:
- Days 0-6: 1 capsule/day
- Days 7-13: 2 capsules/day
- Days 14-20: 3 capsules/day
- Days 21-27: 4 capsules/day
The volunteers visited the center at the beginning of each phase of the intervention period (Days 0, 7, 14 and 21) and at the end of the intervention period (Day 28).
Dietary habits were collected. Compliance was monitored by weekly telephone contact with participants and interviewing them at the end of each intervention period. Blood samples were collected early at the morning after twelve-hour fasting at baseline and at the end of each intervention phase. Blood samples were used for determining all variables of the study. Stool samples were obtained at baseline and after 28 days intervention for the study of bile acids, fatty acids and microbiota.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention trial consisted of a single-center, one-arm study with a total duration of 8 weeks, which includes 2-weeks run-in period, 4 week intervention period and 2-weeks post-intervention or wash-out period. The intervention period was divided in 4 periods of 7 days each and the treatment consisted of increasing dose of Lactobacillus plantarum AB-B (CECT 7527, CECT 7528, CECT 7529).
| Arm | Type | Receives |
|---|---|---|
| Probiotic mixture | Experimental | Dietary Supplement: Probiotic preparation of three Lactobacillus plantarum strains (CECT 7527, CECT 7528, CECT 7529)Arm that received Lactobacillus plantarum mixture (CECT 7527, CECT 7528 and CECT 7529) |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass index (BMI): Between 25 and 30 Kg / m2
Key exclusion criteria (13 listed)
- Eating disorders.
- Subjects with cardiovascular risk factors such as hypercholesterolemia (genetic or secondary), hypertension and diabetes, treated pharmacologically.
- History of ischemic heart disease (and / or previous angina or AMI) or arrhythmia (current or previous).
- Previous strokes and / or peripheral vascular disease.
- Alcohol consumption greater than 60 gr / day.
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 |
|---|---|---|
| Probiotic preparation of three Lactobacillus plantarum strains (CECT 7527, CECT 7528, CECT 7529)Also: AB-LIFEAll subjects were submitted to 4 weeks intervention consisting on a dose-dependent regime of Lactobacillus plantarum AB-B (strains CECT 7527, CECT 7528, CECT 7529; AB-LIFE). Before starting the intervention period, all subjects were submitted to a 2-weeks run-in period. During the wash-in and intervention-periods, participants were instructed to maintain their habitual dietary habits and to continue their normal pattern of physical activity throughout the study period. Treatments during the intervention period were: Week 1: 1 capsule/day taken during breakfast; Week 2: 2 capsules / day at- breakfast; Week 3: 2 capsules at breakfast and 1 at dinner; Week 4: 2capsules at breakfast and 2 capsules at dinner. Each capsule contains 1.2x10^9 cfu (colony forming units) in a 1: 1: 1 ratio of the three strains. | Dietary supplement | Probiotic mixture |
Primary outcome
Change from Baseline Lipid profile at 7 days
Time frame: At days 0 and 7
By standardized biochemical techniques
Change from Baseline Lipid profile at 14 days
Time frame: At days 0 and 14
By standardized biochemical techniques
Change from Baseline Lipid profile at 21 days
Time frame: At days 0 and 21
By standardized biochemical techniques
Change from Baseline Lipid profile at 28 days
Time frame: At days 0 and 28
By standardized biochemical techniques
Change from Baseline Serum bile acids at 14 days
Time frame: At days 0 and 14
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Change from Baseline Serum bile acids at 28 days
Time frame: At days 0 and 28
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Change from Faecal bile acids at 28 days
Time frame: At days 0 and 28
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Change from Baseline Serum fatty acids at 14 days
Time frame: At days 0 and 14
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Change from Baseline Serum fatty acids at 28 days
Time frame: At days 0 and 28
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Change from Baseline Faecal fatty acids at 28 days
Time frame: At days 0 and 28
By ultra-high performance liquid chromatography - mass spectrometry (UHPLC-MS)
Change from Baseline Serum lipoprotein profile at 14 days
Time frame: At days 0 and 14
By nuclear magnetic resonance (NMR)
Change from Baseline Serum lipoprotein profile at 28 days
Time frame: At days 0 and 28
By nuclear magnetic resonance (NMR)
Change from Baseline Plasmatic endocrine hormones and metabolic markers at 14 days
Time frame: At days 0 and 14
By Enzyme-Linked immunosorbent Assay (ELISAs)
Change from Baseline Plasmatic endocrine hormones and metabolic markers at 28 days
Time frame: At days 0 and 28
By Enzyme-Linked immunosorbent Assay (ELISAs)
6 secondary outcomes
Change from Baseline Plasmatic Inflammatory markers at 14 days
Time frame: At days 0 and 14
Change from Baseline Plasmatic Inflammatory markers at 28 days
Time frame: At days 0 and 28
Change from Baseline LDL susceptibility to oxidation and HDL antioxidant capacity at 14 days
Time frame: At days 0 and 14
Change from Baseline LDL susceptibility to oxidation and HDL antioxidant capacity at 28 days
Time frame: At days 0 and 28
Change from Baseline Serum Vitamin D and thyroid hormones (TSH, T3 & T4) at 14 days
Time frame: At days 0 and 14
Change from Baseline Serum Vitamin D and thyroid hormones (TSH, T3 & T4) at 28 days
Time frame: At days 0 and 28
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 7 Jun 2022.
- Derived from this study: PubMed 38525555Padro T, Santisteban V, Huedo P, Puntes M, Aguilo M, Espadaler-Mazo J, Badimon L. Lactiplantibacillus plantarum strains KABP011, KABP012, and KABP013 modulate bile acids and cholesterol metabolism in humans. Cardiovasc Res. 2024 May 29;120(7):708-722. doi: 10.1093/cvr/cvae061.
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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 Probiotic preparation of three Lactobacillus plantarum strains (CECT 7527, CECT 7528, CECT 7529) in people with Probiotic Intervention, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 13 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 7 Jun 2022. 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?
Change from Baseline Lipid profile at 7 days (time frame: At days 0 and 7). The study lists 14 primary outcomes in all. 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 NCT05378230, 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 7 Jun 2022.