Effect of a Combination of Plant Extracts (BSL_EP024) on the Immune Response

• Sponsor: Biosearch S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04029558
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Actual Duration (Days): 30
• Patients Per Site Per Month: 41.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Immune Response	Dietary Supplement: Combination of Plant Extracts (BSL_EP025); Dietary Supplement: Placebo	N/A

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

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jun 3, 2019
• Actual Primary Completion Date: Jul 3, 2019
• Actual Study Completion Date: Jul 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination of plant extracts (BSL_EP024) The volunteers will take two capsules daily with a combination of plant extracts (BSL_EP024)	Dietary Supplement: Combination of Plant Extracts (BSL_EP025); Each participant will consume 2 capsules daily at lunch for 8 weeks.
Placebo Comparator: Placebo The volunteers will take two capsules daily with maltodextrin.	Dietary Supplement: Placebo; Each participant will consume 2 capsules daily at lunch for 8 weeks.

Outcome Measures

Primary Outcome Measures

1. IgM [4 weeks]

   Immunoglobulin M plasma levels

2. IgA [4 weeks]

   Immunoglobulin A plasma levels

3. IgG [4 weeks]

   Immunoglobulin G plasma levels

Secondary Outcome Measures

1. IL-2 [4 weeks]

   Plasma levels of interleukin-2

2. IL-8 [4 weeks]

   Plasma levels of interleukin-8

3. TNF-alpha [4 weeks]

   Plasma levels of tumor necrosis factor alpha

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy adult between 18 and 55 years.

• Accept freely to participate in the study and sign the informed consent document.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Biosearch Life	Granada	Andalucia	Spain	18004

Sponsors and Collaborators

• Biosearch S.A.

Investigators

• Study Chair: Miguel Quesada, MD, PhD, Medical specialist in Endocrinology, Hospital San Cecilio de Granada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biosearch S.A.
• ClinicalTrials.gov Identifier: NCT04029558
• Other Study ID Numbers: C024
• First Posted: Jul 23, 2019
• Last Update Posted: Nov 18, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Biosearch S.A.: Immune response; Plant extracts; Dietary supplement

Study Results

No Results Posted as of Nov 18, 2019