NCT04907097

Effect of MOF on Exercise Blood Pressure

Effect of Monomeric and Oligomeric Flavanols on Exercise Blood Pressure and Vascular Function in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to establish an effect of monomeric and oligomeric flavanols supplementation on exercise blood pressure and vascular function in healthy volunteers.

Detailed description

Exaggerated exercise blood pressure (BP) response in healthy subjects is recognized as a risk factor of hypertension and cardiovascular events. Pathogenetically exaggerated BP response is attributed to compromised vascular(endothelial) functions as well as oxidative stress and inflammation. Monomeric and oligomeric flavanols (MOF) are dietary components with well-characterized beneficial effects on the redox homeostasis, endothelial function and microvascular health. The objectives of the study will be to evaluate the effects of MOF in comparison to placebo on exercise blood pressure, endothelial function, inflammatory and redox status in healthy prehypertensive volunteers. In addition, the study will aim to assess the impact of MOF supplementation on the exercise-induced renin-angiotensin-aldosterone system (RAAS) activation and extracellular matrix remodelling. After being informed about the study and potential risks all volunteers signing informed consent form will undergo screening to determine eligibility for the study. Eligible subjects will be randomized in the double-blind manner to monomeric and oligomeric flavanols /placebo or placebo/monomeric and oligomeric flavanols sequence (cross-over design) in a 1:1 ratio. Monomeric and oligomeric flavanols are derived from grape seeds extract and will be administered in a dose 200 mg per day.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Monomeric and oligomeric flavanols	Monomeric and oligomeric flavanols will be derived from Vitis vinifera seeds extract.
OTHER	Placebo	Placebo capsuled will be used as a comparator.

Timeline

• Start date: 2022-04-05
• Primary completion: 2024-05-16
• Completion: 2024-05-16
• First posted: 2021-05-28
• Last updated: 2024-06-21

Locations

1 site across 1 country: Netherlands