Grape Seed Extract for High Blood Pressure

(GSEBP Trial)

Overseen By Indika Edirisinghe

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of 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.

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.

What data supports the effectiveness of the treatment MegaNatural BP GSE for high blood pressure?

Research shows that grape seed extract can help lower blood pressure, especially in people with pre-hypertension or metabolic syndrome. Some studies found that taking grape seed extract significantly reduced both systolic (the top number) and diastolic (the bottom number) blood pressure. ^{1 2 3 4 5}

Is grape seed extract safe for humans?

Grape seed extract has been found to be safe in humans, as studies have shown no significant adverse effects when used as a supplement. Additionally, a study on rats found no toxic effects at high doses, supporting its safety for human consumption. ^{1 2 3 4 6}

How does the treatment MegaNatural BP® GSE differ from other treatments for high blood pressure?

MegaNatural BP® GSE is unique because it uses grape seed extract, which contains natural compounds that may help lower blood pressure. Unlike some medications, it is a natural supplement that can be taken as part of a lifestyle modification program, and it has shown potential benefits in improving blood pressure in people with pre-hypertension and metabolic syndrome. ^{1 2 3 4 5}

Research Team

Britt Burton-Freeman

Principal Investigator

708-563-8276

Eligibility Criteria

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

I am not on medications that could affect the study results.

Able to provide informed consent

Exclusion Criteria

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

History of eating disorders diagnosed by a health professional

Substance abuse within the last 2 years

Trial Timeline

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

Treatment Details

Interventions

• MegaNatural BP® GSE (Antioxidant)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. United States 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]

2. United States pubmed.ncbi.nlm.nih.gov

The impact of grape seed extract treatment on blood pressure changes: A meta-analysis of 16 randomized controlled trials. [2021]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of grape seed extract on blood pressure in subjects with the metabolic syndrome. [2022]

5. England 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. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Subchronic 3-month oral toxicity study of grape seed and grape skin extracts. [2019]