Overweight and ObesityNCT05069298
Effect of Silibinin(A) as a Potential Anti-obesity Agent
A study testing Silibinin A in people with Overweight and Obesity and Hypercholesterolemia, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Our preliminary reports have found in silico and in vitro that the milk thistle derivative Silibinin(A) is able to inhibit pancreatic lipase, in a similar way that the classical anti-obesity drug orlistat. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Hypercholesterolemia, Hypertriglyceridemia
- What is being tested?
- Silibinin A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jan 2023to 21 Dec 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI > 24,9
- Voluntarily participate in the study
Who cannot join
- significant cognitive impairment
- psychiatric disorders
- chronic pharmacological treatment that may affect the effectiveness of the dietary intervention (corticosteroids, thyroid hormones, oral antidiabetic agents or lipid-lowering drugs)
- chronic disease that may interfere with dietary therapy (cancer, renal or hepatic impairment, chronic gastrointestinal conditions)
- acute disease episodes during the study
- subjects who followed a hypocaloric diet at the allocation time or in the 3 months prior to the beginning of the study
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Milk Thistle Derivative Silibinin(A) as a Potential Anti-obesity Agent
Our preliminary reports have found in silico and in vitro that the milk thistle derivative Silibinin(A) is able to inhibit pancreatic lipase, in a similar way that the classical anti-obesity drug orlistat.
Therefore, the investigators want to carry out the present trial in order to confirm that Silibinin(A) is able to in vivo inhibit pancreatic lipase, which will reduce the fat absorption and therefore will decrease the amount of energy from food intake.
Considering that milk thistle has been extensively studied in humans as liver-protector, the investigators consider that the use of human subjects will be of great interest to accelerate the employment of this compound to improve the effectiveness of dietary treatment in overweight/obese subjects.
- Being tested
- Silibinin A
- Medical subject headings
- Overweight, Obesity, Hypercholesterolemia, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silibinin ADietary supplement
Also called Milk thistle derivative
The compound will be administered following a 300 mg / 3 day schedule, before each main meal.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION | Experimental | Silibinin (A) for three months, with an administration regimen of 3 oral doses of 300 mg per day, before each main meal. Receives: Dietary Supplement: Silibinin A |
| CONTROL | Placebo comparator | Similar treatment regimen, but with a placebo. Receives: Dietary Supplement: Silibinin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of total body weight loss
Change in body weight from baseline to the end of study period (3 months).
Measured: 3 months
Secondary outcomes (6)
Plasma total cholesterol
Change in plasma total cholesterol levels from baseline to the end of study period (3 months).
Measured: 3 months
Plasma low density level cholesterol (cLDL)
Change in plasma cLDL levels from baseline to the end of study period (3 months).
Measured: 3 months
Plasma triglycerides
Change in plasma triglyceride levels from baseline to the end of study period (3 months).
Measured: 3 months
Body mass index (BMI)
Change in BMI from baseline to the end of study period.
Measured: 3 months
Body fat percentage
Change in body fat from baseline to the end of study period.
Measured: 3 months
Waist circumference
Change in waist circumference from baseline to the end of study period.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start12 Jan 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion21 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Jose Hernández Morante, Universidad Católica San Antonio de Murcia
- Investigators
- Juan José Hernández Morante, PhD, Principal investigator, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069298
- Sponsor's protocol ID
- BIO-HPC_1
- Status last verified
- Jun 2023
- First submitted
- 29 May 2021
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data derived from the present trial will be located in public domain databases, concretely in the Mendeley data repository (https://data.mendeley.com/). Nevertheless, all data will be available by request to the main researcher, Dr. Juan José Hernández Morante (e-mail:jjhernandez@ucam.edu).
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Milk Thistle Derivative Silibinin(A) as a Potential Anti-obesity Agent
- ClinicalTrials.gov ID
- NCT05069298
- Acronym / sponsor ID
- BIO-HPC_1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 21 Dec 2023 (estimated)
- First posted
- 6 Oct 2021 (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.
Our preliminary reports have found in silico and in vitro that the milk thistle derivative Silibinin(A) is able to inhibit pancreatic lipase, in a similar way that the classical anti-obesity drug orlistat.
Therefore, the investigators want to carry out the present trial in order to confirm that Silibinin(A) is able to in vivo inhibit pancreatic lipase, which will reduce the fat absorption and therefore will decrease the amount of energy from food intake.
Considering that milk thistle has been extensively studied in humans as liver-protector, the investigators consider that the use of human subjects will be of great interest to accelerate the employment of this compound to improve the effectiveness of dietary treatment in overweight/obese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION | Experimental | Dietary Supplement: Silibinin ASilibinin (A) for three months, with an administration regimen of 3 oral doses of 300 mg per day, before each main meal. |
| CONTROL | Placebo comparator | Dietary Supplement: Silibinin ASimilar treatment regimen, but with a placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI > 24,9
- Voluntarily participate in the study
Key exclusion criteria (7 listed)
- significant cognitive impairment
- psychiatric disorders
- chronic pharmacological treatment that may affect the effectiveness of the dietary intervention (corticosteroids, thyroid hormones, oral antidiabetic agents or lipid-lowering drugs)
- chronic disease that may interfere with dietary therapy (cancer, renal or hepatic impairment, chronic gastrointestinal conditions)
- acute disease episodes during the study
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 |
|---|---|---|
| Silibinin AAlso: Milk thistle derivativeThe compound will be administered following a 300 mg / 3 day schedule, before each main meal. | Dietary supplement | CONTROL, INTERVENTION |
Primary outcome
Percentage of total body weight loss
Time frame: 3 months
Change in body weight from baseline to the end of study period (3 months).
6 secondary outcomes
Plasma total cholesterol
Time frame: 3 months
Plasma low density level cholesterol (cLDL)
Time frame: 3 months
Plasma triglycerides
Time frame: 3 months
Body mass index (BMI)
Time frame: 3 months
Body fat percentage
Time frame: 3 months
Waist circumference
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Webpage of the research group and contact info.Link provided by the sponsor.
- Webpage of other collaboratorsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The data derived from the present trial will be located in public domain databases, concretely in the Mendeley data repository (https://data.mendeley.com/). Nevertheless, all data will be available by request to the main researcher, Dr. Juan José Hernández Morante (e-mail:jjhernandez@ucam.edu).
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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.
Juan José Hernández Morante, PhD principal investigator
Catholic University of Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silibinin A in people with Overweight and Obesity and Hypercholesterolemia, run by Universidad Católica San Antonio de Murcia 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. 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?
Results are not available in the source record.
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?
Percentage of total body weight loss (time frame: 3 months). 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 23 Jun 2023.