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Completed

NCT Number: NCT04179136

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.

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Key information

Conditions

Healthy Volunteers

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

King's College London

London, SE1 9NH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lignan capsules contain 300 mg flaxseed (SDG) extract

Dietary Supplement

lignan capsules contain 300 mg flaxseed (SDG) extract

Placebo treatment matching intervention

Dietary Supplement

Placebo treatment matching intervention

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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.

Other outcomes

  1. 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)

  2. 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)

  3. 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.

  4. 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.

  5. Homeostatic model assessment

    Time frame: Baseline vs 8 weeks post-consumption

    To assess insulin resistance (IR) using homeostatic model assessment (HOMA).

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 27, 2019
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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