Healthy Volunteers
Conditions
Keywords
Cardiovascular system Polyphenols
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTlignan capsules contain 300 mg flaxseed (SDG) extract
lignan capsules contain 300 mg flaxseed (SDG) extract
DIETARY_SUPPLEMENTPlacebo treatment matching intervention
Placebo treatment matching intervention
Sponsors
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double blinded randomized control trial
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in flow-mediated dilation (FMD) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in augmentation Index (AIx) | 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 |
| Change in blood lipid (triglycerides) concentrations | 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 |
| Change in blood inflammatory markers (CRP) | 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. |
| Change in insulin markers | 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. |
| Change in glucose (HbA1c) markers | 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. |
| Change in blood inflammatory markers (IL-6) | 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. |
| Change in glucose marker | 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. |
| Change in flow-mediated dilation (FMD) | 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. |
| Change in office blood pressure | 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. |
| Change in pulse wave velocity (PWV) | 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 |
| Change in Total cholesterol | 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 |
| Change in blood lipid (HDL cholesterol ) concentrations | 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 |
| Change in blood lipid (LDL cholesterol )concentrations | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Menopausal symptoms | 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. |
| Homeostatic model assessment | Baseline vs 8 weeks post-consumption | To assess insulin resistance (IR) using homeostatic model assessment (HOMA). |
| Gut microbiome composition | Baseline vs 8 weeks post-consumption | To investigate changes in gut microbiota composition and diversity after 8 weeks consumption of flaxseed lignans (SDG) extract. |
| Change in metabolic (poly)phenol metabolite concentrations | 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) |
Countries
United Kingdom
Outcome results
None listed