The Role of Gut Microbiome on Cardiovascular Health Benefits of Dietary Lignans (CardioFlax Study).

October 26, 2023 updated by: King's College London

The Role of Gut Microbiome on Cardiovascular Health Benefits of Dietary Lignans ( CardioFlax Study).

The aim of this study is to investigate the effects of gut microbial metabolism of flaxseed lignans on cardiovascular health. Enterolactone is the main gut microbial metabolite of lignans. The study population will be stratified in low and high enterolactone producers and will investigate whether high producers will have greater benefits than low producers, and whether low producers may become high producers after daily consumption of lignans over 8 weeks. The investigators will evaluate changes in endothelial function, blood pressure, arterial stiffness, insulin resistance, lipid profile and gut microbiome composition after 8 weeks daily consumption of flaxseed lignans.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Epidemiological studies have shown inverse relation between enterolactone levels and cardiovascular mortality. Participants will be stratified from first phase (NCT03573414) and then randomly allocated to treatment or placebo. Outcomes are measured at baseline and after 8 weeks post consumption.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9NH
        • King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy women aged 20-70 years
  • BMI between 18 and 35 kg/m2
  • Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
  • Are able to understand the nature of the study
  • Able to give signed written informed consent
  • Signed informed consent form

Exclusion Criteria:

  • Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
  • Hypertensive, as defined as SBP superior or equal to 140 mmHg, and CBP superior or equal to 90 mmHg
  • Participants with BMI superior to 35 kg/m2, and BMI below 18 kg/m2
  • Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies
  • Abnormal heart rhythm (lower or higher than 60-100 bmp)
  • Allergies to flaxseed or other significant food allergy
  • Subjects under medication that can affect the cardiovascular system or on vitamin/dietary supplements.
  • Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
  • Subjects who reported participant in another study within one month before the study start
  • Smoker Subjects
  • Pregnant women or planning to become pregnant in the next 6 months
  • Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High enterolactone producer's (intervention)
lignan capsules contain 300 mg flaxseed (SDG) extract
Dietary supplement: lignan capsules contain 300 mg flaxseed (SDG) extract
lignan capsules contain 300 mg flaxseed (SDG) extract
Placebo Comparator: High enterolactone producer's (Control)
Placebo treatment matching intervention
Dietary supplement: Placebo treatment matching intervention
Placebo treatment matching intervention
Active Comparator: Low enterolactone producer's (intervention)
lignan capsules contain 300 mg flaxseed (SDG) extract
Dietary supplement: lignan capsules contain 300 mg flaxseed (SDG) extract
lignan capsules contain 300 mg flaxseed (SDG) extract
Placebo Comparator: Low enterolactone producer's (Control)
Placebo treatment matching intervention
Dietary supplement: Placebo treatment matching intervention
Placebo treatment matching intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in flow-mediated dilation (FMD)
Time Frame: Baseline vs 8 weeks post-consumption
To investigate the effect of daily consumption of 300 mg of flaxseed (SDG) extract vs Placebo for 8 weeks on endothelium-dependent flow mediated dilation (FMD) of the brachial artery (0, 8 weeks)
Baseline vs 8 weeks post-consumption

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in flow-mediated dilation (FMD)
Time Frame: Day 0, Day1 post-consumption
To investigate the acute effect of 300 mg of flaxseed (SDG) extract vs Placebo on endothelium-dependent flow mediated dilation (FMD) of the brachial artery after 24- hour post-consumption.
Day 0, Day1 post-consumption
Change in office blood pressure
Time Frame: Day 0, Day 1 and 8 weeks post-consumption
To investigate the effect of 300 mg flaxseed lignans (SDG) extract vs Placebo on peripheral systolic and diastolic blood pressure, and heart rate after 8 weeks daily consumption.
Day 0, Day 1 and 8 weeks post-consumption
Change in pulse wave velocity (PWV)
Time Frame: Baseline vs 8 weeks post-consumption
To determine the effect of 300 mg of lignans (SDG) vs Placebo on pulse wave velocity (PWV ) using a Sphygmocor device, after 8 weeks daily consumption
Baseline vs 8 weeks post-consumption
Change in augmentation Index (AIx)
Time Frame: Baseline vs 8 weeks post-consumption
To determine the effect of 300 mg of lignans (SDG) vs Placebo on augmentation index (PWA) using a Sphygmocor device, after 8 weeks daily consumption
Baseline vs 8 weeks post-consumption
Change in Total cholesterol
Time Frame: Baseline vs 8 weeks post-consumption
To investigate the effect of 300 mg Lignans (SDG) extract vs Placebo on blood lipids Total cholesterol after 8 weeks daily consumption
Baseline vs 8 weeks post-consumption
Change in blood inflammatory markers (IL-6)
Time Frame: Baseline vs 8 weeks post-consumption
To investigate the effect of 300 mg lignans (SDG) extract vs Placebo on inflammation markers (IL-6) after 8 weeks daily consumption.
Baseline vs 8 weeks post-consumption
Change in glucose marker
Time Frame: Baseline vs 8 weeks post-consumption
To investigate the effect of 300 mg lignans (SDG) extract vs Placebo on glucose levels (glucose) after 8 weeks daily consumption.
Baseline vs 8 weeks post-consumption
Change in blood lipid (HDL cholesterol ) concentrations
Time Frame: Baseline vs 8 weeks post-consumption
o investigate the effect of 300 mg Lignans (SDG) extract vs Placebo on blood lipids (HDL)after 8 weeks daily consumption
Baseline vs 8 weeks post-consumption
Change in blood lipid (LDL cholesterol )concentrations
Time Frame: Baseline vs 8 weeks post-consumption
o investigate the effect of 300 mg Lignans (SDG) extract vs Placebo on blood lipids( LDL cholesterol) after 8 weeks daily consumption
Baseline vs 8 weeks post-consumption
Change in blood lipid (triglycerides) concentrations
Time Frame: Baseline vs 8 weeks post-consumption
o investigate the effect of 300 mg Lignans (SDG) extract vs Placebo on blood lipids (triglycerides) after 8 weeks daily consumption
Baseline vs 8 weeks post-consumption
Change in blood inflammatory markers (CRP)
Time Frame: Baseline vs 8 weeks post-consumption
To investigate the effect of 300 mg lignans (SDG) extract vs Placebo on inflammation markers ( CRP) after 8 weeks daily consumption.
Baseline vs 8 weeks post-consumption
Change in insulin markers
Time Frame: Baseline vs 8 weeks post-consumption
To investigate the effect of 300 mg lignans (SDG) extract vs Placebo on glucose levels (insulin) after 8 weeks daily consumption.
Baseline vs 8 weeks post-consumption
Change in glucose (HbA1c) markers
Time Frame: Baseline vs 8 weeks post-consumption
To investigate the effect of 300 mg lignans (SDG) extract vs Placebo on glucose levels (HbA1c) after 8 weeks daily consumption.
Baseline vs 8 weeks post-consumption

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in metabolic (poly)phenol metabolite concentrations
Time Frame: Baseline, 24 hand 8 weeks post-consumption
To determine the plasma levels of polyphenol metabolites after acute and chronic consumption of flaxseed lignans (SDG).Measured by liquid chromotography-mass spectrometry (LC/MS)
Baseline, 24 hand 8 weeks post-consumption
Change in metabolic (poly)phenol metabolite concentrations
Time Frame: Baseline vs 8 weeks post-consumption
To determine the urine levels of polyphenol metabolites baseline and chronic consumption of flaxseed lignans (SDG). Measured by liquid chromotography-mass spectrometry (LC/MS)
Baseline vs 8 weeks post-consumption
Gut microbiome composition
Time Frame: Baseline vs 8 weeks post-consumption
To investigate changes in gut microbiota composition and diversity after 8 weeks consumption of flaxseed lignans (SDG) extract.
Baseline vs 8 weeks post-consumption
Menopausal symptoms
Time Frame: Baseline vs 8 weeks post-consumption
To investigate the effect of 300 mg flaxseed lignans (SDG) extract vs Placebo on menopausal symptoms using menopausal questionnaire for women over 45 years.
Baseline vs 8 weeks post-consumption
Homeostatic model assessment
Time Frame: Baseline vs 8 weeks post-consumption
To assess insulin resistance (IR) using homeostatic model assessment (HOMA).
Baseline vs 8 weeks post-consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr.Ana Rodriguez-Mateos, PhD, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CardioFlax study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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