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

NCT04179136 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-10-27

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

lignan capsules contain 300 mg flaxseed (SDG) extract

lignan capsules contain 300 mg flaxseed (SDG) extract

DIETARY_SUPPLEMENT

Placebo treatment matching intervention

Placebo treatment matching intervention

Sponsors & Collaborators

Principal Investigators

  • Dr.Ana Rodriguez-Mateos, PhD · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2021-07-30
Completion
2021-07-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04179136 on ClinicalTrials.gov