NCT04179136

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-11-25
• Primary completion: 2021-07-30
• Completion: 2021-07-30
• First posted: 2019-11-27
• Last updated: 2023-10-27

Locations

1 site across 1 country: United Kingdom