Actively Recruiting

Phase Not Applicable
Age: 40Years - 60Years
All Genders
NCT06555952

MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors

Led by Clinical Nutrition Research Center, Illinois Institute of Technology · Updated on 2025-07-15

80

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Inflammation and stressors can interfere with the function of the lining of blood vessels and insulin activity, therefore, investigators are aiming to see how the Grape seed Extract (GSE) called MegaNatural BP can help with limiting the effects of these factors. This research will study the effects of taking 150mg of MegaNatural BP GSE per day on blood pressure levels along with influences on heart health through assessing the function of the blood vessel lining and levels of inflammation.

CONDITIONS

Official Title

MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors

Who Can Participate

Age: 40Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 40 and 60 years
  • Body mass index (BMI) less than 30 kg/m2
  • Elevated blood pressure with systolic 120-140 mmHg and diastolic less than 90 mmHg at screening
  • Fasting blood glucose between 100-125 mg/dL or HbA1c between 5.7% and 6.4%
  • Not taking medications that affect blood pressure or diabetes
  • Able to give informed consent
  • Able to follow study procedures including dietary restrictions, study food consumption, diaries, and study visits
  • Able to maintain usual physical activity
  • Able to avoid alcohol and vigorous exercise 24 hours before and during study visits
Not Eligible

You will not qualify if you...

  • Known or suspected allergies or intolerance to study foods or interventions
  • Diagnosis of diabetes or liver, kidney, heart, gastrointestinal, metabolic, or respiratory diseases
  • Physical or mental conditions or major surgeries that limit participation or affect study results
  • Women who are pregnant, planning pregnancy, or breastfeeding
  • Taking medications or supplements that may interfere with study outcomes, including anti-inflammatory drugs
  • Major trauma or surgery within past 2 months (or longer)
  • Use of antibiotics within past 2 months
  • Colonoscopy within past 3 months
  • History of eating disorders diagnosed by a health professional
  • Substance abuse within last 2 years
  • Consuming more than 4 cups of coffee or tea daily
  • Blood donation within last 3 months
  • Regular excessive exercise or being an athlete
  • Unstable weight with gain or loss of 5 kg or more in last 2 months
  • Women on unstable hormonal contraceptives or stable use less than 6 months
  • Working unusual hours such as overnight shifts
  • Following vegan or extreme dietary patterns

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinical Nutrition Research Center

Chicago, Illinois, United States, 60616

Actively Recruiting

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Research Team

I

Indika Edirisinghe

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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