Health Trials

MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors

ConditionsHypertensionPre Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorClinical Nutrition Research Center, Illinois Institute of Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

40-60 years of age

BMI < 30kg/m2

elevated blood pressure 120-140 mmHg (systolic) / <90 mmHg (diastolic) at screening visit

Has fasting blood glucose concentration between 100-125 mg/dL or HbA1c 5.7-6.4%.

Disqualifiers

Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or interventions

Men and women with diabetes or have documented liver, kidney, cardiac, gastrointestinal, metabolic or respiratory diseases.

Men and women with documented physical or mental disease/condition or major surgery as revealed by history or physical examination, which might limit participation in or completion of the study or, that, in the opinion of the investigator, could interfere with the interpretation of the study results.

Women who are known to be pregnant or who are intending to become pregnant over the course of the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • MegaNatural-BP SR 150Mg Tablet

    Dietary supplement

    GSE MegaNatural BP

  • Placebo Capsule

    Other intervention

    given in place of GSE MegaNatural BP

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: GSE CapsuleExperimental treatment 1 intervention
Group B: Placebo CapsulePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Difference in change of systolic blood pressure

After 6 weeks of 150mg GSE MegaNatural BP per day the base level blood pressure should change

Time frame
6 weeks
2

Difference in change of diastolic blood pressure

After 6 weeks of 150mg GSE MegaNatural BP per day the base level blood pressure should change

Time frame
6 weeks

Secondary outcomes

1

Change in vessel flexibility

Change in vessel flexibility as measured by flow mediated vasodilation acutely and chronically after GSE MegaNatural BP

Time frame
6 weeks
2

Change in fasting and postprandial glucose

Change in fasting and postprandial glucose as measured by absolute values and calculated insulin sensitivity using homeostasis model assessment of fasting insulin senisitivity (HOMA-%S) and B-cell function (HOMA-%) and assessment of peripheral insulin sensitivity using Matsuda index.

Time frame
6 weeks
3

Change in fasting and postprandial insulin

Change in fasting and postprandial insulin as measured by absolute values and calculated insulin sensitivity using homeostasis model assessment of fasting insulin senisitivity (HOMA-%S) and B-cell function (HOMA-%) and assessment of peripheral insulin sensitivity using Matsuda index.

Time frame
6 weeks
4

Change in inflammatory marker C-reactive protein

additional plasma collected and saved for future analysis as study results warrant

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinical Nutrition Research Center, Illinois Institute of Technology

Lead sponsor

Source ClinicalTrials.gov
Apply now