Grape Seed Extract for High Blood Pressure

(GSEBP Trial)

Overseen By Indika Edirisinghe

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology

Must not be taking: Blood pressure, Anti-diabetes, Anti-inflammatory

Disqualifiers: Diabetes, Cardiac, Liver, Kidney, others

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the grape seed extract supplement, MegaNatural BP, can lower blood pressure and improve heart health by reducing inflammation. Participants will take either the grape seed supplement or a placebo (a pill with no active ingredients) to compare effects. The trial seeks individuals with slightly elevated blood pressure (120-140/under 90) and higher than normal blood sugar levels (but not diabetes). As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially enhance personal health.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications that could interfere with the study, such as blood pressure lowering medications, anti-diabetes medications, and certain anti-inflammatory medications like ibuprofen or aspirin.

Is there any evidence suggesting that MegaNatural BP GSE is likely to be safe for humans?

Research has shown that MegaNatural BP grape seed extract (GSE) has been tested in several clinical trials to assess its effects on blood pressure and heart health. In these studies, participants took 150mg of the extract daily. The results indicated that both systolic and diastolic blood pressure numbers were lower after taking GSE compared to a placebo. Importantly, no major side effects were reported, indicating that the treatment was generally well-tolerated. This suggests that MegaNatural BP GSE might be a safe option for those interested in naturally managing their blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MegaNatural BP® Grape Seed Extract (GSE) for high blood pressure because it offers a natural alternative to traditional medications like ACE inhibitors, beta-blockers, and diuretics. Unlike these standard treatments, which can have a range of side effects and work by altering hormone levels or heart function, GSE is derived from grape seeds and is believed to improve blood pressure by enhancing blood vessel function and reducing oxidative stress. This unique mechanism, along with its natural origin, makes it a promising option for those seeking a more holistic approach to managing high blood pressure.

What evidence suggests that MegaNatural BP GSE might be an effective treatment for high blood pressure?

Research has shown that MegaNatural BP, a grape seed extract, can help lower blood pressure. One study found that adults with slightly high blood pressure experienced a 5.6% drop in systolic blood pressure after taking the extract for 12 weeks. Another study discovered that MegaNatural BP helped maintain both systolic and diastolic blood pressure within normal ranges over eight weeks. Additional research indicates that this extract benefits heart health, particularly in maintaining healthy blood vessel function. In this trial, participants will receive either a GSE Capsule containing MegaNatural BP or a Placebo Capsule. These findings suggest that MegaNatural BP grape seed extract may effectively manage blood pressure and support heart health. ^{1 3 4 6 7}

Who Is on the Research Team?

Britt Burton-Freeman

Principal Investigator

708-563-8276

Are You a Good Fit for This Trial?

This trial is for individuals with prediabetes and high blood pressure. Participants should be interested in testing a grape seed extract supplement to see if it can improve their heart health by reducing blood pressure and inflammation.

Inclusion Criteria

Elevated blood pressure of 120-140 mmHg (systolic) and less than 90 mmHg (diastolic) at screening visit

Able to provide informed consent

Able to comply with study procedures including dietary restrictions, consumption of study foods, record keeping, sample collection, and study visit schedule

Exclusion Criteria

History of eating disorders diagnosed by a health professional

Substance abuse within the last 2 years

I do not have any health conditions that would stop me from completing a study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Pre-Study / Pre-Intervention

Participants receive detailed instructions on study procedures and are fitted with an ambulatory blood pressure device

1 visit

1 visit (in-person)

Treatment

Participants take 150mg of MegaNatural BP GSE daily and attend study visits for blood pressure monitoring and blood sample collection

6 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MegaNatural BP® GSE

Trial Overview The study tests the effects of MegaNatural BP, a specific grape seed extract (GSE), at a dose of 150mg daily against a placebo. It aims to determine whether this GSE can positively affect blood vessel function and reduce cardiometabolic risk factors.

How Is the Trial Designed?

Group I: GSE Capsule Experimental Treatment 1 Intervention

150mg Grapeseed Extract MegaNatural BP

Group II: Placebo Capsule Placebo Group 1 Intervention

Placebo supplement in place of GSE capsule

Who Is Running the Clinical Trial?

Clinical Nutrition Research Center, Illinois Institute of Technology

Lead Sponsor

Trials

55

Recruited

3,000+

Published Research Related to This Trial

In a study involving Wistar rats on a high-fat, high-carbohydrate diet, low-molecular-weight grape-seed polyphenol extract (LM-GSPE) effectively reduced blood pressure and improved lipid metabolism, indicating its potential as a treatment for hypertension and metabolic syndrome.

Doses of 25 and 100 mg/kg per day of LM-GSPE were sufficient to lower blood pressure and improve lipid profiles, while a higher dose of 200 mg/kg per day was needed to significantly reduce body weight and waist perimeter.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic administration of grape-seed polyphenols attenuates the development of hypertension and improves other cardiometabolic risk factors associated with the metabolic syndrome in cafeteria diet-fed rats. Pons, Z., Margalef, M., Bravo, FI., et al.[2018]

In a 4-week study involving subjects with metabolic syndrome, grape seed extracts (GSE) significantly lowered both systolic and diastolic blood pressure compared to a placebo.

No significant changes were observed in serum lipids or blood glucose levels, indicating that GSE may be a beneficial addition to lifestyle modifications for managing blood pressure in metabolic syndrome patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of grape seed extract on blood pressure in subjects with the metabolic syndrome. Sivaprakasapillai, B., Edirisinghe, I., Randolph, J., et al.[2022]

In a 12-week study involving 36 middle-aged adults with pre-hypertension, grape seed extract (GSE) significantly reduced systolic blood pressure by 5.6% and diastolic blood pressure by 4.7% after 6 weeks compared to placebo, indicating its efficacy as a functional ingredient for blood pressure control.

GSE was found to be safe for consumption, and those with higher initial blood pressure experienced nearly double the reduction, suggesting that GSE could be particularly beneficial for individuals with more severe pre-hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of grape seed extract beverage on blood pressure and metabolic indices in individuals with pre-hypertension: a randomised, double-blinded, two-arm, parallel, placebo-controlled trial. Park, E., Edirisinghe, I., Choy, YY., et al.[2022]

Grape seed extract significantly reduces both systolic and diastolic blood pressure, with a weighted mean difference of -6.077 mmHg for systolic and -2.803 mmHg for diastolic pressure based on a meta-analysis of 16 clinical trials involving 810 participants.

The blood pressure-lowering effects of grape seed extract are particularly pronounced in younger individuals, obese subjects, and patients with metabolic syndrome, suggesting that these groups may benefit the most from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of grape seed extract treatment on blood pressure changes: A meta-analysis of 16 randomized controlled trials. Zhang, H., Liu, S., Li, L., et al.[2021]

A 3-month study on rats showed that dietary concentrations of up to 2.5% grape seed extract (GSE) and grape skin extract (GSKE) did not result in any significant toxic effects, establishing a no-observed-adverse effect level (NOAEL) for these extracts.

The study indicates that proanthocyanidins in GSE and GSKE are safe for consumption at the tested levels, supporting their use as functional food ingredients with antioxidant properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subchronic 3-month oral toxicity study of grape seed and grape skin extracts. Bentivegna, SS., Whitney, KM.[2019]

MegaNatural®-BP grape seed extract was tested in two human studies, with one showing a potential benefit in maintaining normal blood pressure when taken at 300 mg/day for 6 weeks, while the other study found no effect over 8 weeks.

The evidence was insufficient to confirm a clear cause-and-effect relationship between MegaNatural®-BP consumption and blood pressure maintenance, and no plausible mechanism of action was established for its effects in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MegaNatural®-BP grape seed extract and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. [2021]

Citations

1. plthealth.com plthealth.com/product-catalog/meganatural-bp

PLT Health MegaNatural-BP At eight weeks, MegaNatural®-BP was found to help maintain blood pressure levels (systolic and diastolic) within the normal range. * Robinson M, Lu B, ...

2. withpower.com withpower.com/trial/phase-impaired-glucose-tolerance-7-2024-bf14f

Grape Seed Extract for High Blood Pressure (GSEBP Trial) In a 12-week study involving 36 middle-aged adults with pre-hypertension, grape seed extract (GSE) significantly reduced systolic blood pressure by 5.6% and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06555952

NCT06555952 | MegaNatural BP® GSE on Blood Pressure ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8350889/

MegaNatural®‐BP grape seed extract and maintenance of ... The Panel considers that this study performed in adults with normal and high normal blood pressure showed an effect of MegaNatural®‐BP given at ...

5. polyphenolics.com polyphenolics.com/wp-content/uploads/2017/04/3-MegaNatural-BP-Brochure.pdf

MegaNatural®-BP: The patented grape seed extract with ... In fact, three placebo- controlled human clinical trials conducted by researchers at the Department of Preventative Cardiology, University of California Davis ...

6. efsa.europa.eu efsa.europa.eu/en/efsajournal/pub/6776

BP grape seed extract and maintenance of normal ... - EFSA The evidence provided is insufficient to establish a cause and effect relationship between the consumption of MegaNatural®‐BP and maintenance of normal blood ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0026049509002455

Effect of grape seed extract on blood pressure in subjects ... Both the systolic and diastolic blood pressures were lowered after treatment with GSE as compared with placebo. There were no significant changes in serum ...