An interventional study of MegaNatural-BP SR 150Mg Tablet and Placebo Capsule in Hypertension and Pre Diabetes, sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology. Recruiting at 1 site in United States. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology · Not applicable, Interventional, and Prevention
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.
This is a research study to determine if an extract made from grape seeds might help control blood pressure. Previous research studies have found that taking this extract as a daily supplement at 300 mg per day in a capsule or a beverage may lower blood pressure in individuals with elevated blood pressure levels. The commercial name of this supplement is called MegaNatural BP®. The principal investigators of this study were part of the original research studies on GSE (both MegaNatural BP GSE and MegaNatural Gold GSE). They are now interested to determine if a lower amount of the grape seed extract might be effective in lowering people's blood pressure when its elevated. There is also some earlier information suggesting the GSE may influence how well insulin works in people's body. This may be helpful for individuals with metabolic conditions like the early stages of pre-diabetes.
The study will last for six weeks. All participants will visit the Clinical Nutrition Research Center (CNRC) seven times over the course of the study. These visits include a screening visit, two ambulatory blood pressure device fitting visits, and four study day visits throughout the six weeks. Blood will be collected to assess insulin activity measures during subject visits to the CNRC. The flexibility of subject's blood vessels will be measured using an ultrasound technique. Flexibility of vessels is important for blood pressure regulation and GSE has been known to help them become more flexible.
SCREENING VISIT
A subject's eligibility for the study is based on the list (inclusion and exclusion criteria). Clinical Research Coordinators will determine if the subject qualifies for the study at the Screening Visit by the following measurements:
PRE-STUDY / PRE-INTERVENTION VISIT (which may be performed at the same or different day as screening visit) The Pre-Study visit lasts \~30-45 minutes and the subject will meet with one of the investigators who will provide detailed instructions on procedures of the study (Blood pressure devices) and "how to prepare for each of the study days." The subject will be trained on all study procedures including, but not limited to foods to avoid during the study, medications/supplements to avoid, food diary recording, and GI-tract diary recording, fasting overnight. The participants study dates will be scheduled, and they will be provided a study booklet, including the study calendar and all instructions covered at the Pre-Study Visit.
Medications/Supplements: If the subject is taking any medications or supplements that do not interfere with the study or have been OK'd by study staff, they will take those as instructed by their doctor and will record in the diary. Clinical Research Coordinators will train the subject on what foods or supplements are OK and NOT OK during the study at the Pre-Study Visit.
Self-Characteristics and Dietary Surveys: During this visit, participants will be asked to complete online surveys that cover usual gastrointestinal (GI) symptoms and a 24-hour food recall.
Ambulatory Blood Pressure Device Fitting and Baseline BP measurement (Day 0) At the pre-study visit or another scheduled day at the participants convenience, the subject will be fitted with an ambulatory blood pressure device (ABPD) for collection of blood pressure for 24 h during their wake and sleep time. This is the most accurate assessment of their true blood pressure. They will begin wearing the device once fitted until returning the next day, which they will need to return to the clinic. As part of the 24 h device wearing, investigators will ask that the subject keeps a sleep, wake, exercise, eating diary. This helps the clinic understand the subject's data and when the blood pressure increases and decreases.
The subject will be given a frozen dinner to consume before they start fasting. This meal will be the same meal that is consumed before Visit 5.
STUDY DAY VISITS
Study Visit 1 / Day 1 Procedures
Staff collects study materials from participant
Confirmation the subject is ready to go for their study day by interview/discussion with study staff
Ultrasound for Flow mediated dilation (FMD): FMD is a procedure to test the flexibility of brachial vessels. The researcher will use an ultrasound machine to visualize the artery in the subject's arm. The sonographer, who will visual the arm artery and conduct the procedure, will add sensors to the subject's body to track their heart rate and inflate a blood pressure cuff for 5 minutes on their arm before releasing to see and measure by ultrasound how flexible the arteries are. This will take about 30 minutes. The procedure will take place again 120 min after breakfast.
Blood collection: The subject will see the Licensed Health Care Provider (LHCP) for blood sample collection. The subject has the choice of an intravenous catheter or multiple butterfly sticks. There will be eight blood draws total. Once the fasting blood draw is collected, investigators will provide the subject with a capsule and then 5 min later a breakfast in the form of a nutritionally complete liquid drink (Ensure). Blood samples will be collected over the next 3 hours via a multi-sampling protocol. The subject will then be provided capsules for daily intake over two weeks until the next visit.
Other procedures. Every effort will be made to ensure the subjects safety while participating in this study.
Anthropometrics: Researchers will measure the subject's height as well as weight and body composition. Researchers will repeat the weight measurements as shown in the table. The subject will be asked to wear light comfortable clothing when coming to the screening and study related visits.
Vital signs: Researchers will check the subjects blood pressure, heart rate and body temperature using standard clinic devices.
Demographic questionnaire, health and medication questionnaire: Subjects will be asked to provide personal information, such as name, date of birth, race, etc. They will also be asked to answer questions about demographics, health, medical history, and the medications they take.
Study Visits 2 and 3 Procedures- Pick Up Visit Visit 2 (two weeks after Visit 1) and Visit 3 (two weeks after Visit 2) will involve a weight check, blood draw for compliance and supplement refill and reconciliation.
Study Visit 4- ABPD Fitting Procedure One day before Visit 5, the subject will be expected to come into the CNRC to be fitted with an ABPD. The subject will wear the ABPD day and night and fill out the 24 hour log until returning to the clinic for the final visit 5 the next day.
The subject will be given a frozen dinner to consume before they start fasting. This meal is the same as PreStudy or before Visit 1.
Study Visit 5 Procedures Visit 5 (two weeks after Visit 3) is the final study day visit. This visit will take place the day after Visit 4. This visit will be exactly the same as Visit 1, except the LMTT will include a capsule of the dietary regimens (placebo or MN-BP) that are randomly assigned to participants. After all study procedures are completed, the participant will be given a take-home snack and compensation will be issued.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Clinical Nutrition Research Center, Illinois Institute of Technology is the lead sponsor of 61 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
150mg Grapeseed Extract MegaNatural BP
Dietary Supplement: MegaNatural-BP SR 150Mg Tablet
Placebo supplement in place of GSE capsule
Other: Placebo Capsule
GSE MegaNatural BP
given in place of GSE MegaNatural BP
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
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
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
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
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
Change in inflammatory marker C-reactive protein
additional plasma collected and saved for future analysis as study results warrant
Time frame: 6 weeks
Change in the ratio of arginine:ADMA
will be analyzed using High Performance Liquid Chromatography with mass analysis capabilities of mass spectrometry (MS)
Time frame: 6 weeks
Change in GSE metabolites profiles
will be analyzed using High Performance Liquid Chromatography with mass analysis capabilities of mass spectrometry (MS)
Time frame: 6 weeks
Plan to share: No
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