Effect of MOF on Exercise Blood Pressure

NCT ID: NCT04907097

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-05
• Study Completion Date: 2024-05-16

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

MOF/placebo

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).

Group Type: OTHER

Monomeric and oligomeric flavanols

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Intervention Type: OTHER

Placebo capsuled will be used as a comparator.

Placebo/MOF

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).

Group Type: OTHER

Monomeric and oligomeric flavanols

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Intervention Type: OTHER

Placebo capsuled will be used as a comparator.

Interventions

Monomeric and oligomeric flavanols

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo capsuled will be used as a comparator.

Intervention Type: OTHER

Other Intervention Names

Masquelier's original OPCs

Eligibility Criteria

Inclusion Criteria

1. Healthy men and women with normal to high-normal resting BP (SBP 120 - 139 mm Hg and DBP 80 - 89 mm Hg).

2. Age 35 - 65 years

3. BMI 20 - 32 kg/m^2

4. Hypertensive response to maximal exercise test defined as SBP ≥ 200 mm Hg (men) and ≥ 180 mm Hg (women).

Exclusion Criteria

1. Active engagement in the weight loss programs, also including slimming diets.

2. Active smoking or abstinence from smoking for less than one year.

3. Use of medications that reduce BP and/or can potentially influence other study outcomes (ACE-inhibitors, angiotensin receptor blockers, diuretics, painkillers, etc).

4. Intake of polyphenol-containing supplements for two month before and during the whole course of the study.

5. History of diabetes, cardiovascular, respiratory, renal, gastrointestinal, hepatic or other diseases and conditions, which potentially can compromise participation in this study.

6. Intense sporting (>10 h/week) and/or participation in the competition at the professional level.

7. Pregnancy or breastfeeding.

8. Participation in a clinical trial within 4 weeks prior to inclusion into this study.

9. Vaccination against Covid-19 within two months before the screening/randomization visit or expected vaccination against Covid-19 during the study

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VieCuri Medical Centre

OTHER

Sponsor Role: collaborator

CEP Group Holding B.V.

UNKNOWN

Sponsor Role: collaborator

Campus Venlo

UNKNOWN

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Khrystyna Semen

Professor assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khrystyna O. Semen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor assistant

Locations

VieCuri Medical Center

Venlo, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

NL77344.068.21

Identifier Type: -

Identifier Source: org_study_id