NCT04029818

Brief Summary

The aim of the present study is to evaluate the ability of Bifidobacterium BSL\_PS404 in reducing LDL-cholesterol levels in healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 cardiovascular-diseases

Timeline
Completed

Started May 2019

Shorter than P25 for phase_1 cardiovascular-diseases

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

May 24, 2019

Completed
2 months 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
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

November 15, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

July 22, 2019

Last Update Submit

November 14, 2019

Conditions

Cardiovascular DiseasesLDL-cholesterol

Keywords

LDL-cholesterolProbiotics

Outcome Measures

Primary Outcomes (1)

  • LDL-cholesterol

    Levels of LDL-cholesterol in plasma

    8 weeks

Secondary Outcomes (6)

  • Total cholesterol

    8 weeks

  • HDL-cholesterol

    8 weeks

  • Triglycerides

    8 weeks

  • Glucose

    8 weeks

  • Blood pressure

    8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Probiotic

EXPERIMENTAL

Volunteers will take a capsule with Bifidobacterium BSL\_PS404 (3x109 cfu) daily.

Biological: Bifidobacterium BSL_PS404

Placebo

PLACEBO COMPARATOR

Volunteers will take a capsule with maltodextrin daily.

Biological: Placebo

Interventions

Bifidobacterium BSL_PS404BIOLOGICAL

Each participant will consume 1 capsule daily at lunch for 8 weeks.

Probiotic
PlaceboBIOLOGICAL

Each participant will consume 1 capsule daily at lunch for 8 weeks.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Levels of LDL-cholesterol between 100 and 190 mg/dL.
  • Accept freely to participate in the study and sign the informed consent document.

You may not qualify if:

  • Be pregnant.
  • Have planned to carry out a dietary intervention or exercise practice with the aim of losing weight in the coming weeks.
  • Having a serious illness.
  • Having diabetes.
  • Having a cerebrovascular disease.
  • Being allergic to any group of antibiotics.
  • Take probiotics in the form of supplements at least 4 weeks before.
  • Take antibiotics at least 4 weeks before.
  • Being taking products or drugs to control cholesterol levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital San Cecilio

Granada, Andalusia, 18016, Spain

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Miguel Quesada, MD, PhD

    Medical specialist in Endocrinology, Hospital San Cecilio de Granada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
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

May 24, 2019

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

November 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)