Healthy VolunteersNCT04179136
The Role of Gut Microbiome on Cardiovascular Health Benefits of Dietary Lignans (CardioFlax Study).
A study testing lignan capsules contain 300 mg flaxseed (SDG) extract in people with Healthy Volunteers, run by King's College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- lignan capsules contain 300 mg flaxseed (SDG) extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2019to 30 Jul 2021
- 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 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- lignan capsules contain 300 mg flaxseed (SDG) extract, Placebo treatment matching intervention
- Keywords
- Cardiovascular system Polyphenols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lignan capsules contain 300 mg flaxseed (SDG) extractDietary supplement
lignan capsules contain 300 mg flaxseed (SDG) extract
Placebo treatment matching interventionDietary supplement
Placebo treatment matching intervention
| Study group | Role | What they receive |
|---|---|---|
| High enterolactone producer's (intervention) | Active comparator | lignan capsules contain 300 mg flaxseed (SDG) extract Receives: Dietary Supplement: lignan capsules contain 300 mg flaxseed (SDG) extract |
| High enterolactone producer's (Control) | Placebo comparator | Placebo treatment matching intervention Receives: Dietary Supplement: Placebo treatment matching intervention |
| Low enterolactone producer's (intervention) | Active comparator | lignan capsules contain 300 mg flaxseed (SDG) extract Receives: Dietary Supplement: lignan capsules contain 300 mg flaxseed (SDG) extract |
| Low enterolactone producer's (Control) | Placebo comparator | Placebo treatment matching intervention Receives: Dietary Supplement: Placebo treatment matching intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in flow-mediated dilation (FMD)
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)
Measured: Baseline vs 8 weeks post-consumption
Secondary outcomes (13)
Change in flow-mediated dilation (FMD)
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.
Measured: Day 0, Day1 post-consumption
Change in office blood pressure
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.
Measured: Day 0, Day 1 and 8 weeks post-consumption
Change in pulse wave velocity (PWV)
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
Measured: Baseline vs 8 weeks post-consumption
Change in augmentation Index (AIx)
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
Measured: Baseline vs 8 weeks post-consumption
Change in Total cholesterol
To investigate the effect of 300 mg Lignans (SDG) extract vs Placebo on blood lipids Total cholesterol after 8 weeks daily consumption
Measured: Baseline vs 8 weeks post-consumption
Change in blood inflammatory markers (IL-6)
To investigate the effect of 300 mg lignans (SDG) extract vs Placebo on inflammation markers (IL-6) after 8 weeks daily consumption.
Measured: Baseline vs 8 weeks post-consumption
Change in glucose marker
To investigate the effect of 300 mg lignans (SDG) extract vs Placebo on glucose levels (glucose) after 8 weeks daily consumption.
Measured: Baseline vs 8 weeks post-consumption
Change in blood lipid (HDL cholesterol ) concentrations
- investigate the effect of 300 mg Lignans (SDG) extract vs Placebo on blood lipids (HDL)after 8 weeks daily consumption
Measured: Baseline vs 8 weeks post-consumption
Change in blood lipid (LDL cholesterol )concentrations
- investigate the effect of 300 mg Lignans (SDG) extract vs Placebo on blood lipids( LDL cholesterol) after 8 weeks daily consumption
Measured: Baseline vs 8 weeks post-consumption
Change in blood lipid (triglycerides) concentrations
- investigate the effect of 300 mg Lignans (SDG) extract vs Placebo on blood lipids (triglycerides) after 8 weeks daily consumption
Measured: Baseline vs 8 weeks post-consumption
Change in blood inflammatory markers (CRP)
To investigate the effect of 300 mg lignans (SDG) extract vs Placebo on inflammation markers ( CRP) after 8 weeks daily consumption.
Measured: Baseline vs 8 weeks post-consumption
Change in insulin markers
To investigate the effect of 300 mg lignans (SDG) extract vs Placebo on glucose levels (insulin) after 8 weeks daily consumption.
Measured: Baseline vs 8 weeks post-consumption
Change in glucose (HbA1c) markers
To investigate the effect of 300 mg lignans (SDG) extract vs Placebo on glucose levels (HbA1c) after 8 weeks daily consumption.
Measured: Baseline vs 8 weeks post-consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start25 Nov 2019
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Model description
- Double blinded randomized control trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Ana Rodriguez-Mateos, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179136
- Sponsor's protocol ID
- CardioFlax study
- Status last verified
- Nov 2019
- First submitted
- 21 Nov 2019
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Gut Microbiome on Cardiovascular Health Benefits of Dietary Lignans ( CardioFlax Study).
- ClinicalTrials.gov ID
- NCT04179136
- Acronym / sponsor ID
- CardioFlax study
- Conditions
- Healthy Volunteers
- Keywords
- Cardiovascular system Polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 27 Nov 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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double blinded randomized control trial
| Arm | Type | Receives |
|---|---|---|
| High enterolactone producer's (intervention) | Active comparator | Dietary Supplement: lignan capsules contain 300 mg flaxseed (SDG) extractlignan capsules contain 300 mg flaxseed (SDG) extract |
| High enterolactone producer's (Control) | Placebo comparator | Dietary Supplement: Placebo treatment matching interventionPlacebo treatment matching intervention |
| Low enterolactone producer's (intervention) | Active comparator | Dietary Supplement: lignan capsules contain 300 mg flaxseed (SDG) extractlignan capsules contain 300 mg flaxseed (SDG) extract |
| Low enterolactone producer's (Control) | Placebo comparator | Dietary Supplement: Placebo treatment matching interventionPlacebo treatment matching intervention |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
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 |
|---|---|---|
| lignan capsules contain 300 mg flaxseed (SDG) extractlignan capsules contain 300 mg flaxseed (SDG) extract | Dietary supplement | High enterolactone producer's (intervention), Low enterolactone producer's (intervention) |
| Placebo treatment matching interventionPlacebo treatment matching intervention | Dietary supplement | High enterolactone producer's (Control), Low enterolactone producer's (Control) |
Primary outcome
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)
13 secondary outcomes
Change in flow-mediated dilation (FMD)
Time frame: Day 0, Day1 post-consumption
Change in office blood pressure
Time frame: Day 0, Day 1 and 8 weeks post-consumption
Change in pulse wave velocity (PWV)
Time frame: Baseline vs 8 weeks post-consumption
Change in augmentation Index (AIx)
Time frame: Baseline vs 8 weeks post-consumption
Change in Total cholesterol
Time frame: Baseline vs 8 weeks post-consumption
Change in blood inflammatory markers (IL-6)
Time frame: Baseline vs 8 weeks post-consumption
Change in glucose marker
Time frame: Baseline vs 8 weeks post-consumption
Change in blood lipid (HDL cholesterol ) concentrations
Time frame: Baseline vs 8 weeks post-consumption
Change in blood lipid (LDL cholesterol )concentrations
Time frame: Baseline vs 8 weeks post-consumption
Change in blood lipid (triglycerides) concentrations
Time frame: Baseline vs 8 weeks post-consumption
Change in blood inflammatory markers (CRP)
Time frame: Baseline vs 8 weeks post-consumption
Change in insulin markers
Time frame: Baseline vs 8 weeks post-consumption
Change in glucose (HbA1c) markers
Time frame: Baseline vs 8 weeks post-consumption
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 27 Oct 2023.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Dr.Ana Rodriguez-Mateos, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lignan capsules contain 300 mg flaxseed (SDG) extract in people with Healthy Volunteers, run by King's College London at 1 site in United Kingdom.
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 6 inclusion and 12 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 27 Oct 2023. 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 United Kingdom. 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?
Change in flow-mediated dilation (FMD) (time frame: Baseline vs 8 weeks post-consumption). 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 27 Oct 2023.