Dietary Capsaicin for High Blood Pressure

Overseen By Stephen Ives, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Skidmore College

Must not be taking: Immune suppressants

Disqualifiers: Pregnancy, Severe illness, Food allergies, others

Compensation: Varies

Number of Visits: 24

Duration: 6 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have uncontrolled hypertension or are taking immune suppressants, you may be excluded from participating.

What data supports the effectiveness of the treatment Dietary Capsaicin for high blood pressure?

Research on rats with a specific type of high blood pressure showed that dietary capsaicin, found in chili peppers, can lower blood pressure by helping blood vessels relax. This effect is likely due to increased production of nitric oxide, a molecule that helps widen blood vessels. ^{1 2 3 4 5}

Is dietary capsaicin safe for humans?

Research on animals suggests that dietary capsaicin is generally safe, with no major adverse effects observed in studies, although high doses may affect body weight and organ size. However, there are reports of capsaicin causing complex cardiovascular effects and even a hypertensive crisis in some cases, indicating that its safety may depend on the dose and individual response. ^{1 6 7 8 9}

How does dietary capsaicin treatment for high blood pressure differ from other treatments?

Dietary capsaicin is unique because it uses a natural compound found in chili peppers to potentially lower blood pressure, unlike traditional medications that often involve synthetic drugs. This approach is part of a broader interest in using nutraceuticals (foods with health benefits) for managing blood pressure, especially in people with slightly elevated levels who may not need prescription medications. ^{2 10 11 12 13}

What is the purpose of this trial?

The investigators long-term goal is to better understand novel interventions to promote cardiovascular health in humans. The goal of the proposed research is to investigate whether there is sex-specificity in the effects of dietary capsaicin on mechanisms regulating nitric oxide (NO) bioavailability, its effect on key markers of cardiovascular (CV) health, including BP, macro- and microvascular function, and arterial stiffness. This knowledge will provide critical insight into the effects of dietary capsaicin on CV health and will guide future trials.

Eligibility Criteria

This trial is for non-smoking men and women over 18 with high blood pressure, but otherwise healthy. It's not for those with heartburn, stomach issues, food allergies, trouble swallowing pills, or a severe sensitivity to spicy foods. People with serious illnesses or uncontrolled hypertension can't join. Women who are pregnant, trying to conceive, breastfeeding or without a period (not due to birth control) are also excluded.

Exclusion Criteria

I have heartburn, hiatal hernia, gastritis, or peptic ulcer disease.

Participants with food allergies

I have trouble swallowing or taking pills.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week dietary capsaicin intervention to assess its effects on cardiovascular health

6 weeks

Baseline, 24 hours, and 6-week visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dietary Capsaicin

Trial Overview The study tests if dietary capsaicin affects cardiovascular health differently in men and women by looking at nitric oxide levels and markers like blood pressure and arterial stiffness. Participants will take dietary capsules containing capsaicin.

Participant Groups

Group I: Dietary Capsaicin Experimental Treatment 1 Intervention

Over-the-counter dose of 2 x 440 mg capsules (880 mg, Capsicum Pepper Blend, Daily Manufacturing, Rockwell, North Carolina, USA)

Group II: Placebo Placebo Group 1 Intervention

The placebo will be 2 x 400-500 mg fiber (800 mg psyllium husk) capsules which were chosen to be of similar appearance (size, coloration, and texture).

Who Is Running the Clinical Trial?

Skidmore College

Lead Sponsor

Trials

20

Recruited

1,100+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Findings from Research

In a study involving 2-kidney, 1-clip hypertensive rats, dietary capsaicin significantly reduced both systolic and mean arterial blood pressure compared to a control diet, suggesting its potential as a dietary intervention for hypertension.

The blood pressure-lowering effect of capsaicin appears to be mediated by enhanced phosphorylation of endothelial nitric oxide synthase (eNOS) and protein kinase B (Akt), indicating a mechanism involving increased nitric oxide production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary capsaicin-mediated attenuation of hypertension in a rat model of renovascular hypertension. Segawa, Y., Hashimoto, H., Maruyama, S., et al.[2020]

A systematic review of 7 trials involving 363 subjects found that capsinoids and fermented red pepper paste (FRPP) significantly reduced diastolic blood pressure (DBP) by an average of 1.90 mmHg, but did not significantly affect systolic blood pressure (SBP).

FRPP supplementation showed a significant reduction in SBP, particularly in studies lasting 12 weeks or more and with sample sizes greater than 50, indicating its potential effectiveness in managing blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of capsinoids and fermented red pepper paste supplementation on blood pressure: A systematic review and meta-analysis of randomized controlled trials. Amini, MR., Sheikhhossein, F., Bazshahi, E., et al.[2022]

Capsaicin, the active component in chili peppers, shows potential for weight management based on animal studies, but it is not a standalone solution for obesity.

Emerging evidence suggests that capsaicin may help restore a healthy gut microbiota, which could contribute to overall health, although it should not be viewed as a miracle weight-loss remedy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capsaicin for Weight Control: "Exercise in a Pill" (or Just Another Fad)? Szallasi, A.[2022]

In Dahl salt-sensitive (DS) rats, a high-salt diet significantly increased blood pressure, indicating that these rats are more susceptible to hypertension compared to Dahl salt-resistant (DR) rats.

The TRPV1 receptor plays a protective role against salt-induced hypertension; its activation and expression are impaired in DS rats, while in DR rats, TRPV1 activation helps to lower blood pressure in response to high salt intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel mechanism contributing to development of Dahl salt-sensitive hypertension: role of the transient receptor potential vanilloid type 1. Wang, Y., Wang, DH.[2018]

Regular consumption of chili peppers, which contain capsaicin, is associated with a lower risk of cardiovascular disease and potentially longer life, suggesting a beneficial impact on metabolic health.

Despite the association with reduced mortality, dietary capsaicin does not appear to significantly affect blood glucose or lipid levels, indicating that its health benefits may be linked to changes in gut microbiota rather than direct metabolic improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Capsaicin: A Spicy Way to Improve Cardio-Metabolic Health? Szallasi, A.[2023]

Acute ingestion of large amounts of chili peppers, which contain capsaicin, can lead to a hypertensive crisis, as observed in a patient, suggesting a significant impact on blood pressure.

Experimental studies in anesthetized rats indicate that the hypertensive response from capsaicin is not mediated by adrenergic or angiotensin mechanisms, but may involve direct action on vascular smooth muscle or activation of endothelin, highlighting a unique pathway for capsaicin's effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms underlying the hypertensive response induced by capsaicin. Dutta, A., Deshpande, SB.[2022]

The study evaluated the safety of a new formulation of capsaicinoids-rich red chili pepper extract (Capsifen®) using fenugreek-derived fiber, showing no adverse effects in Wistar rats at various doses over 14 days, except for some weight loss at higher doses.

The Low-observed-adverse-effect level (LOAEL) for Capsifen was determined to be 500 mg/kg body weight per day, indicating that this dosage is safe for consumption without significant negative health impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety assessment of a fenugreek dietary fiber-based formulation of capsaicinoids-rich red chili (Capsicum annum) extract (Capsifen®): Acute and sub-chronic studies. Joseph, A., Nm, J., Kumar, S., et al.[2020]

Capsaicin produces a complex, dose-dependent effect on blood pressure and heart rate in male Wistar rats, with an initial drop in both followed by a transient and sustained increase in blood pressure when injected intravenously.

The cardiovascular responses to capsaicin are influenced by the method of administration, as a slow infusion leads to sustained blood pressure increases and tachycardia, indicating that the effects of capsaicin can vary significantly based on dosage and delivery speed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The acute effects of capsaicin on the cardiovascular system. Chahl, LA., Lynch, AM.[2018]

Dietary capsaicin significantly reduces heart enlargement, improves cardiac function, and decreases fibrosis in mice subjected to pressure overload, but these protective effects depend on the presence of the TRPV1 receptor.

In TRPV1 knockout mice, the beneficial effects of capsaicin on cardiac health were absent, indicating that TRPV1 is essential for capsaicin's protective role against cardiac hypertrophy and fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary capsaicin ameliorates pressure overload-induced cardiac hypertrophy and fibrosis through the transient receptor potential vanilloid type 1. Wang, Q., Ma, S., Li, D., et al.[2022]

Recent randomized controlled trials have demonstrated that certain dietary patterns and food items can significantly lower blood pressure, which is important for managing hypertension in both individuals and populations.

Specific studies, such as the DASH trials and others, highlight the effectiveness of dietary changes like salt restriction and weight control as alternatives to medication, while also noting that regular coffee consumption may raise blood pressure in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent developments concerning diet and hypertension. Beilin, LJ., Burke, V., Puddey, IB., et al.[2019]

Elevated blood pressure is a significant risk factor for stroke and coronary heart disease, particularly when systolic/diastolic levels exceed 140/90 mmHg, highlighting the importance of managing hypertension.

Recent studies suggest that nutraceuticals and functional foods, such as the DASH diet, garlic, and fish oil, may serve as effective alternative therapies for prehypertensive patients, offering a natural approach to lowering blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-hypertensive nutraceuticals and functional foods. Chen, ZY., Peng, C., Jiao, R., et al.[2009]

The Japanese cuisine-based DASH (J-DASH) diet significantly lowered home blood pressure (BP) and reduced BP variability in participants with untreated high-normal BP or stage 1 hypertension over a 6-month study involving 40 participants.

The J-DASH diet was found to be feasible and more effective than usual diets in managing blood pressure, indicating its potential as a dietary intervention for hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Japanese Cuisine-Based Antihypertensive Diet and Fish Oil on Blood Pressure and Its Variability in Participants with Untreated Normal High Blood Pressure or Stage I Hypertension: A Feasibility Randomized Controlled Study. Umemoto, S., Onaka, U., Kawano, R., et al.[2022]

A 14-day inpatient trial with 9 volunteers showed that switching from a high-sodium, low-potassium diet to the DASH diet led to a significant decrease in blood pressure, with an average reduction of 3.7 mmHg systolic and 2.3 mmHg diastolic.

The study revealed that this dietary change caused an initial increase in serum aldosterone levels, which then decreased while still on the DASH diet, indicating a complex hormonal response that contributes to blood pressure reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum aldosterone and urine electrolytes dynamics in response to DASH diet intervention - An inpatient mechanistic study. Bielopolski, D., Qureshi, A., Bentur, OS., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Dietary capsaicin-mediated attenuation of hypertension in a rat model of renovascular hypertension. [2020]

2. England pubmed.ncbi.nlm.nih.gov

The effects of capsinoids and fermented red pepper paste supplementation on blood pressure: A systematic review and meta-analysis of randomized controlled trials. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Capsaicin for Weight Control: "Exercise in a Pill" (or Just Another Fad)? [2022]

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

A novel mechanism contributing to development of Dahl salt-sensitive hypertension: role of the transient receptor potential vanilloid type 1. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Capsaicin: A Spicy Way to Improve Cardio-Metabolic Health? [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Mechanisms underlying the hypertensive response induced by capsaicin. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Safety assessment of a fenugreek dietary fiber-based formulation of capsaicinoids-rich red chili (Capsicum annum) extract (Capsifen®): Acute and sub-chronic studies. [2020]

8. Hungary pubmed.ncbi.nlm.nih.gov

The acute effects of capsaicin on the cardiovascular system. [2018]

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

Dietary capsaicin ameliorates pressure overload-induced cardiac hypertrophy and fibrosis through the transient receptor potential vanilloid type 1. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Recent developments concerning diet and hypertension. [2019]

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

Anti-hypertensive nutraceuticals and functional foods. [2009]

12. Japan pubmed.ncbi.nlm.nih.gov

Effects of a Japanese Cuisine-Based Antihypertensive Diet and Fish Oil on Blood Pressure and Its Variability in Participants with Untreated Normal High Blood Pressure or Stage I Hypertension: A Feasibility Randomized Controlled Study. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Serum aldosterone and urine electrolytes dynamics in response to DASH diet intervention - An inpatient mechanistic study. [2022]