NCT04907097

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

April 5, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

2.1 years

First QC Date

May 25, 2021

Last Update Submit

June 20, 2024

Conditions

Healthy

Keywords

Vascular functionMonomeric and oligomeric flavanolsGrape seeds extractExercise blood pressureInflammation

Outcome Measures

Primary Outcomes (2)

  • Change in systolic blood pressure from before to peak value during the submaximal exercise test

    Excessive increase in systolic blood pressure during exercise is a well-characterized risk-factor of cardiovascular disease and is related to signs of sub clinical endothelial dysfunction.

    Day 28±3, Day 84±3

  • Change in mean blood pressure from before to peak value during the submaximal exercise test

    Increase in mean blood pressure during exercise is related to signs of endothelial dysfunction.

    Day 28±3, Day 84±3

Secondary Outcomes (7)

  • Carotid-femoral pulse wave velocity

    Day 28±3, Day 84±3

  • Biomarkers of RAAS activation

    Day 28±3, Day 84±3

  • Biomarkers of inflammation

    Day 28±3, Day 84±3

  • Biomarkers of oxidative stress

    Day 28±3, Day 84±3

  • Biomarkers of endothelial function

    Day 28±3, Day 84±3

  • +2 more secondary outcomes

Study Arms (2)

MOF/placebo

OTHER

During period 1 (4 weeks) participants will receive monomeric and oligomeric flavanols and during period 2 (4 weeks) placebo. Wash out period between two interventions will be 4 weeks. The daily dose of monomeric and oligomeric flavanols will be 200 mg (2 capsules once a day) and for placebo (2 capsules once a day).

Dietary Supplement: Monomeric and oligomeric flavanolsOther: Placebo

Placebo/MOF

OTHER

During period 1 (4 weeks) participants will receive placebo and during period 2 (4 weeks) monomeric and oligomeric flavanols. The wash out period between two interventions will be 4 weeks. The daily dose of placebo will be 2 capsules once a day and for monomeric and oligomeric flavanols 200 mg (2 capsules once a day).

Dietary Supplement: Monomeric and oligomeric flavanolsOther: Placebo

Interventions

Monomeric and oligomeric flavanolsDIETARY_SUPPLEMENT

Monomeric and oligomeric flavanols will be derived from Vitis vinifera seeds extract.

Also known as: Masquelier's original OPCs
MOF/placeboPlacebo/MOF
PlaceboOTHER

Placebo capsuled will be used as a comparator.

MOF/placeboPlacebo/MOF

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and women with normal to high-normal resting BP (SBP 120 - 139 mm Hg and DBP 80 - 89 mm Hg).
  • Age 35 - 65 years
  • BMI 20 - 32 kg/m\^2
  • Hypertensive response to maximal exercise test defined as SBP ≥ 200 mm Hg (men) and ≥ 180 mm Hg (women).

You may not qualify if:

  • Active engagement in the weight loss programs, also including slimming diets.
  • Active smoking or abstinence from smoking for less than one year.
  • Use of medications that reduce BP and/or can potentially influence other study outcomes (ACE-inhibitors, angiotensin receptor blockers, diuretics, painkillers, etc).
  • Intake of polyphenol-containing supplements for two month before and during the whole course of the study.
  • History of diabetes, cardiovascular, respiratory, renal, gastrointestinal, hepatic or other diseases and conditions, which potentially can compromise participation in this study.
  • Intense sporting (\>10 h/week) and/or participation in the competition at the professional level.
  • Pregnancy or breastfeeding.
  • Vaccination against Covid-19 within two months before the screening/randomization visit or expected vaccination against Covid-19 during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VieCuri Medical Center

Venlo, Limburg, 5912 BL, Netherlands

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Khrystyna O. Semen, MD, PhD

    Professor assistant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor assistant

Study Record Dates

First Submitted

May 25, 2021

First Posted

May 28, 2021

Study Start

April 5, 2022

Primary Completion

May 16, 2024

Study Completion

May 16, 2024

Last Updated

June 21, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)