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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04179136
• Other study ID #: CardioFlax study
• Status: Completed
• Phase: N/A
• Start date: November 25, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: November 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• lignan capsules contain 300 mg flaxseed (SDG) extract
lignan capsules contain 300 mg flaxseed (SDG) extract
• Placebo treatment matching intervention
Placebo treatment matching intervention

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in metabolic (poly)phenol metabolite concentrations	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
Other	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
Other	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
Other	Homeostatic model assessment	To assess insulin resistance (IR) using homeostatic model assessment (HOMA).	Baseline vs 8 weeks post-consumption
Primary	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
Secondary	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
Secondary	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.	Day 0, Day 1 and 8 weeks post-consumption
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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