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

NCT04179136 | Completed

• 1 other identifier: CardioFlax study
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Cardiovascular system Polyphenols

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in flow-mediated dilation (FMD)

  Day 0, Day1 post-consumption

• Change in office blood pressure

  Day 0, Day 1 and 8 weeks post-consumption

• Change in pulse wave velocity (PWV)

  Baseline vs 8 weeks post-consumption

• Change in augmentation Index (AIx)

  Baseline vs 8 weeks post-consumption

• Change in Total cholesterol

  Baseline vs 8 weeks post-consumption

Other Outcomes (5)

• Change in metabolic (poly)phenol metabolite concentrations

  Baseline, 24 hand 8 weeks post-consumption

• Change in metabolic (poly)phenol metabolite concentrations

  Baseline vs 8 weeks post-consumption

• Gut microbiome composition

  Baseline vs 8 weeks post-consumption

Study Arms (4)

High enterolactone producer's (intervention)

ACTIVE COMPARATOR

lignan capsules contain 300 mg flaxseed (SDG) extract

Dietary Supplement: lignan capsules contain 300 mg flaxseed (SDG) extract

High enterolactone producer's (Control)

PLACEBO COMPARATOR

Placebo treatment matching intervention

Dietary Supplement: Placebo treatment matching intervention

Low enterolactone producer's (intervention)

ACTIVE COMPARATOR

lignan capsules contain 300 mg flaxseed (SDG) extract

Dietary Supplement: lignan capsules contain 300 mg flaxseed (SDG) extract

Low enterolactone producer's (Control)

PLACEBO COMPARATOR

Placebo treatment matching intervention

Dietary Supplement: Placebo treatment matching intervention

Interventions

lignan capsules contain 300 mg flaxseed (SDG) extract DIETARY_SUPPLEMENT

lignan capsules contain 300 mg flaxseed (SDG) extract

High enterolactone producer's (intervention); Low enterolactone producer's (intervention)

Placebo treatment matching intervention DIETARY_SUPPLEMENT

Placebo treatment matching intervention

High enterolactone producer's (Control); Low enterolactone producer's (Control)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College London

London, SE1 9NH, United Kingdom

Location

MeSH Terms

Interventions

Lignans; Linseed Oil; secoisolariciresinol

Intervention Hierarchy (Ancestors)

Benzyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Dr.Ana Rodriguez-Mateos, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blinded randomized control trial

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 27, 2019
• Study Start: November 25, 2019
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: October 27, 2023

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)