NCT04029558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
Last Updated

November 18, 2019

Status Verified

July 1, 2019

Enrollment Period

1 month

First QC Date

July 22, 2019

Last Update Submit

November 14, 2019

Conditions

Immune Response

Keywords

Immune responsePlant extractsDietary supplement

Outcome Measures

Primary Outcomes (3)

  • IgM

    Immunoglobulin M plasma levels

    4 weeks

  • IgA

    Immunoglobulin A plasma levels

    4 weeks

  • IgG

    Immunoglobulin G plasma levels

    4 weeks

Secondary Outcomes (3)

  • IL-2

    4 weeks

  • IL-8

    4 weeks

  • TNF-alpha

    4 weeks

Study Arms (2)

Combination of plant extracts (BSL_EP024)

EXPERIMENTAL

The volunteers will take two capsules daily with a combination of plant extracts (BSL\_EP024)

Dietary Supplement: Combination of Plant Extracts (BSL_EP025)

Placebo

PLACEBO COMPARATOR

The volunteers will take two capsules daily with maltodextrin.

Dietary Supplement: Placebo

Interventions

Combination of Plant Extracts (BSL_EP025)DIETARY_SUPPLEMENT

Each participant will consume 2 capsules daily at lunch for 8 weeks.

Combination of plant extracts (BSL_EP024)
PlaceboDIETARY_SUPPLEMENT

Each participant will consume 2 capsules daily at lunch for 8 weeks.

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult between 18 and 55 years.
  • Accept freely to participate in the study and sign the informed consent document.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biosearch Life

Granada, Andalusia, 18004, Spain

Location

Study Officials

  • Miguel Quesada, MD, PhD

    Medical specialist in Endocrinology, Hospital San Cecilio de Granada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 23, 2019

Study Start

June 3, 2019

Primary Completion

July 3, 2019

Study Completion

July 3, 2019

Last Updated

November 18, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)