Clinical trial NCT04179136: The Role of Gut Microbiome on Cardiovascular Health Benefits of Dietary Lignans (CardioFlax Study).
Official title: The Role of Gut Microbiome on Cardiovascular Health Benefits of Dietary Lignans ( CardioFlax Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Cardiovascular system Polyphenols
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 45
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded randomized control trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in flow-mediated dilation (FMD)
timeFrame: Baseline vs 8 weeks post-consumption
Secondary outcomes:
measure: Change in flow-mediated dilation (FMD)
timeFrame: Day 0, Day1 post-consumption
measure: Change in office blood pressure
timeFrame: Day 0, Day 1 and 8 weeks post-consumption
measure: Change in pulse wave velocity (PWV)
timeFrame: Baseline vs 8 weeks post-consumption
measure: Change in augmentation Index (AIx)
timeFrame: Baseline vs 8 weeks post-consumption
measure: Change in Total cholesterol
timeFrame: Baseline vs 8 weeks post-consumption
measure: Change in blood inflammatory markers (IL-6)
timeFrame: Baseline vs 8 weeks post-consumption
measure: Change in glucose marker
timeFrame: Baseline vs 8 weeks post-consumption
measure: Change in blood lipid (HDL cholesterol ) concentrations
timeFrame: Baseline vs 8 weeks post-consumption
measure: Change in blood lipid (LDL cholesterol )concentrations
timeFrame: Baseline vs 8 weeks post-consumption
measure: Change in blood lipid (triglycerides) concentrations
timeFrame: Baseline vs 8 weeks post-consumption
measure: Change in blood inflammatory markers (CRP)
timeFrame: Baseline vs 8 weeks post-consumption
measure: Change in insulin markers
timeFrame: Baseline vs 8 weeks post-consumption
measure: Change in glucose (HbA1c) markers
timeFrame: Baseline vs 8 weeks post-consumption
Other outcomes:
measure: Change in metabolic (poly)phenol metabolite concentrations
timeFrame: Baseline, 24 hand 8 weeks post-consumption
measure: Change in metabolic (poly)phenol metabolite concentrations
timeFrame: Baseline vs 8 weeks post-consumption
measure: Gut microbiome composition
timeFrame: Baseline vs 8 weeks post-consumption
measure: Menopausal symptoms
timeFrame: Baseline vs 8 weeks post-consumption
measure: Homeostatic model assessment
timeFrame: Baseline vs 8 weeks post-consumption
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Dr.Ana Rodriguez-Mateos, PhD
role: PRINCIPAL_INVESTIGATOR
References: