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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High enterolactone producer's (intervention) | Active Comparator | lignan capsules contain 300 mg flaxseed (SDG) extract |
|
| High enterolactone producer's (Control) | Placebo Comparator | Placebo treatment matching intervention |
|
| Low enterolactone producer's (intervention) | Active Comparator | lignan capsules contain 300 mg flaxseed (SDG) extract |
|
| Low enterolactone producer's (Control) | Placebo Comparator | Placebo treatment matching intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lignan capsules contain 300 mg flaxseed (SDG) extract | Dietary Supplement | lignan capsules contain 300 mg flaxseed (SDG) extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline vs 8 weeks post-consumption |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0, Day1 post-consumption |
| Change in office blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Change in metabolic (poly)phenol metabolite concentrations | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr.Ana Rodriguez-Mateos, PhD | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College London | London | SE1 9NH | United Kingdom |
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| ID | Term |
|---|---|
| D017705 | Lignans |
| D008043 | Linseed Oil |
| C060283 | secoisolariciresinol |
| ID | Term |
|---|---|
| D001593 | Benzyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Double blinded randomized control trial
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| Placebo treatment matching intervention | Dietary Supplement | Placebo treatment matching intervention |
|
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) | 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) | 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 | 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) | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 |
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 | 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 | 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 | To assess insulin resistance (IR) using homeostatic model assessment (HOMA). | Baseline vs 8 weeks post-consumption |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D005224 | Fats, Unsaturated |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |