Immune ResponseNCT04029558
Effect of a Combination of Plant Extracts (BSL_EP024) on the Immune Response
A study testing Combination of Plant Extracts (BSL_EP025) in people with Immune Response, run by Biosearch S.A. at 1 site in Spain.
Trial summary
The aim of the present trial is to study the effect of the combination of plant extracts (BSL_EP024) in the activation of the immune response. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Response
- What is being tested?
- Combination of Plant Extracts (BSL_EP025)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jun 2019to 3 Jul 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult between 18 and 55 years.
- Accept freely to participate in the study and sign the informed consent document.
Who cannot join
- Be under pharmacological treatments that may affect the immune response (anti-inflammatory drugs of chronic or frequent use, antiallergic treatments).
- Have allergy to some plant extracts
- Suffer from gastric problems or ulcers.
- Receive treatment with anticoagulant activity.
- Have a low expectation of adherence to the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Nutritional Intervention, Randomized, Double Blind and Controlled Parallel Groups to Evaluate the Effect of the Consumption of the Combination of Plant Extracts (BSL_EP024) on the Immune Response in Adults
The aim of the present trial is to study the effect of the combination of plant extracts (BSL_EP024) in the activation of the immune response.
Read the detailed description
More than 90% of the diseases are related, directly or indirectly, with immune alterations. Traditionally, protection against infections and improvement of the immune response has been addressed by natural means through the use of plant extracts. This activity has been attributed to phenolic compounds.
The aim of the present study is to evaluate the effect of the combination of plant extracts (BSL_EP024) on immunological response parameters.
- Conditions
- Immune Response
- Being tested
- Combination of Plant Extracts (BSL_EP025), Placebo
- Keywords
- Immune response, Plant extracts, Dietary supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Plant Extracts (BSL_EP025)Dietary supplement
Each participant will consume 2 capsules daily at lunch for 8 weeks.
PlaceboDietary supplement
Each participant will consume 2 capsules daily at lunch for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Combination of plant extracts (BSL_EP024) | Experimental | The volunteers will take two capsules daily with a combination of plant extracts (BSL_EP024) Receives: Dietary Supplement: Combination of Plant Extracts (BSL_EP025) |
| Placebo | Placebo comparator | The volunteers will take two capsules daily with maltodextrin. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgM
Immunoglobulin M plasma levels
Measured: 4 weeks
IgA
Immunoglobulin A plasma levels
Measured: 4 weeks
IgG
Immunoglobulin G plasma levels
Measured: 4 weeks
Secondary outcomes (3)
IL-2
Plasma levels of interleukin-2
Measured: 4 weeks
IL-8
Plasma levels of interleukin-8
Measured: 4 weeks
TNF-alpha
Plasma levels of tumor necrosis factor alpha
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start3 Jun 2019
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ResponseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miguel Quesada, MD, PhD, Study chair, Medical specialist in Endocrinology, Hospital San Cecilio de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029558
- Sponsor's protocol ID
- C024
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Nutritional Intervention, Randomized, Double Blind and Controlled Parallel Groups to Evaluate the Effect of the Consumption of the Combination of Plant Extracts (BSL_EP024) on the Immune Response in Adults
- ClinicalTrials.gov ID
- NCT04029558
- Acronym / sponsor ID
- C024
- Conditions
- Immune Response
- Keywords
- Immune response, Plant extracts, Dietary supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 23 Jul 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 aim of the present trial is to study the effect of the combination of plant extracts (BSL_EP024) in the activation of the immune response.
Detailed description
More than 90% of the diseases are related, directly or indirectly, with immune alterations. Traditionally, protection against infections and improvement of the immune response has been addressed by natural means through the use of plant extracts. This activity has been attributed to phenolic compounds.
The aim of the present study is to evaluate the effect of the combination of plant extracts (BSL_EP024) on immunological response parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination of plant extracts (BSL_EP024) | Experimental | Dietary Supplement: Combination of Plant Extracts (BSL_EP025)The volunteers will take two capsules daily with a combination of plant extracts (BSL_EP024) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe volunteers will take two capsules daily with maltodextrin. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult between 18 and 55 years.
- Accept freely to participate in the study and sign the informed consent document.
Key exclusion criteria (5 listed)
- Be under pharmacological treatments that may affect the immune response (anti-inflammatory drugs of chronic or frequent use, antiallergic treatments).
- Have allergy to some plant extracts
- Suffer from gastric problems or ulcers.
- Receive treatment with anticoagulant activity.
- Have a low expectation of adherence to the study protocol.
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 |
|---|---|---|
| Combination of Plant Extracts (BSL_EP025)Each participant will consume 2 capsules daily at lunch for 8 weeks. | Dietary supplement | Combination of plant extracts (BSL_EP024) |
| PlaceboEach participant will consume 2 capsules daily at lunch for 8 weeks. | Dietary supplement | Placebo |
Primary outcome
IgM
Time frame: 4 weeks
Immunoglobulin M plasma levels
IgA
Time frame: 4 weeks
Immunoglobulin A plasma levels
IgG
Time frame: 4 weeks
Immunoglobulin G plasma levels
3 secondary outcomes
IL-2
Time frame: 4 weeks
IL-8
Time frame: 4 weeks
TNF-alpha
Time frame: 4 weeks
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 18 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Miguel Quesada, MD, PhD study chair
Medical specialist in Endocrinology, Hospital San Cecilio de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of Plant Extracts (BSL_EP025) in people with Immune Response, run by Biosearch S.A. 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 5 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 18 Nov 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?
IgM (time frame: 4 weeks). The study lists 3 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 18 Nov 2019.