Peanuts for Brain and Heart Health

Overseen By Alison Mancera, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Arlington

Disqualifiers: Peanut allergy, Hypertensive crisis, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether increased peanut consumption can improve brain and heart health. Peanuts possess beneficial properties, such as reducing inflammation and combating harmful substances in the body. Participants will either increase their peanut intake or maintain their current diet. Individuals with a peanut allergy, those experiencing a hypertensive crisis, or those with certain other specified conditions are not eligible to participate. The study targets Black or White individuals without peanut allergies and with a parent of the same race, focusing on potential daily health benefits from peanuts. As an unphased trial, it offers a unique opportunity to contribute to understanding the broader health benefits of peanuts.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that increased peanut consumption is safe for humans?

Research shows that peanuts can be safely included in most diets. One study found that regularly eating peanuts links to a lower risk of stroke and heart disease. Specifically, people who ate four to five peanuts a day had a 16% lower risk of experiencing any type of stroke. Another study found that peanuts might help reduce inflammation, which connects to heart disease and diabetes.

Peanuts are often given to young children to help prevent allergies, suggesting they are generally well-tolerated. While these findings highlight the health benefits of peanuts, they also reassure about their safety for daily consumption. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for brain and heart health that often involve pharmaceuticals or specific lifestyle changes, the treatment under study here is simply the consumption of peanuts. Peanuts are unique because they are rich in polyphenols, which have anti-inflammatory and antioxidant properties. Researchers are excited about this treatment because it offers a natural, food-based approach that could provide health benefits without the side effects associated with medications. Additionally, this approach is accessible and easy to incorporate into daily life, which could improve adherence and overall health outcomes.

What evidence suggests that increased peanut consumption could be effective for brain and heart health?

Research shows that eating peanuts regularly might benefit the brain and heart. In this trial, participants in the "Peanut Consumption" arm will consume peanuts, which are rich in polyphenols and possess anti-inflammatory and antioxidant properties. Studies have found that people who eat peanuts have a lower risk of strokes and heart disease. Specifically, one study found that eating more peanuts was linked to fewer total and ischemic strokes, caused by blocked blood flow to the brain. Another study noted that eating nuts like peanuts can lower the risk of heart-related illnesses by up to 21%. However, some research indicates that peanuts do not significantly change certain heart disease risk factors, so more research is needed to fully understand their impact. Participants in the "Non-peanut consumption" arm will not consume any additional supplements in their diet. ^{1 2 6 7 8}

Who Is on the Research Team?

Robert M Brothers, PhD

Principal Investigator

University of Texas at Arlington

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-50 who identify as white or black, with at least one parent of the same race/ethnicity. It's not for those with peanut allergies, in hypertensive crisis, pregnant or breastfeeding women, people allergic to spandex/lycra, or anyone who donated a lot of blood recently.

Inclusion Criteria

I am either a man or a woman.

Individuals that self-identify as white or black and who have at least one biological parent who identifies as their own self-identified race/ethnicity

Exclusion Criteria

Breast feeding

Individuals with peanut allergy

Individuals in hypertensive crisis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume peanuts daily to assess impact on neurocognitive and cardiovascular health

8 weeks

Baseline and follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peanut group

Trial Overview The study is looking at how eating more peanuts daily affects brain function and heart health in Black individuals. Participants will be asked to include peanuts in their diet regularly to see if there are any benefits.

How Is the Trial Designed?

Group I: Peanut Consumption Experimental Treatment 1 Intervention

Peanuts are rich in polyphenols and also have anti-inflammatory and antioxidant properties.

Group II: Non-peanut consumption Active Control 1 Intervention

The non-peanut consumption will simply not be consuming any additional supplements in their diet

Who Is Running the Clinical Trial?

The University of Texas at Arlington

Lead Sponsor

Trials

48

Recruited

7,300+

Published Research Related to This Trial

A meta-analysis of 13 randomized controlled trials found that peanut consumption does not significantly affect various cardiovascular disease (CVD) risk factors such as weight, blood pressure, and cholesterol levels, indicating that peanuts may not be a major factor in reducing CVD risk.

However, peanut consumption was associated with a significant increase in high-density lipoprotein (HDL) cholesterol levels, particularly when using high-oleic peanuts or peanut oil, suggesting a potential benefit for heart health in certain contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peanut and cardiovascular disease risk factors: A systematic review and meta-analysis. Jafari Azad, B., Daneshzad, E., Azadbakht, L.[2020]

Higher nut consumption is associated with a significant reduction in all-cause mortality (RR 0.81) and specific causes of death, particularly cardiovascular disease (RR 0.75) and coronary heart disease (RR 0.73), based on an analysis of 18 prospective studies involving over 81,000 deaths.

Most health benefits from nut consumption can be achieved with about 3 servings per week, indicating that even moderate intake can lead to lower mortality risks, particularly for heart-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nut consumption in relation to all-cause and cause-specific mortality: a meta-analysis 18 prospective studies. Chen, GC., Zhang, R., Martínez-González, MA., et al.[2018]

Regular consumption of nuts, such as walnuts, almonds, and hazelnuts, is associated with a significant reduction in the risk of major cardiovascular events by approximately 30% over five years, as shown in the PREDIMED trial.

Nuts not only lower cholesterol levels but also improve glycemic control, blood pressure, and inflammation, making them beneficial for overall health without contributing to obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nuts: Natural Pleiotropic Nutraceuticals. Ros, E., Singh, A., O'Keefe, JH.[2021]

In a study involving 61 older adults, consuming unsalted peanuts for 12 weeks significantly improved cerebrovascular perfusion, with a 5% increase in blood flow in the left middle cerebral artery and a 7% increase in the right middle cerebral artery.

Participants also showed enhanced cognitive performance, including better short-term memory and processing speed, suggesting that the bioactive nutrients in peanuts may contribute to these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebrovascular and cognitive benefits of high-oleic peanut consumption in healthy overweight middle-aged adults. Barbour, JA., Howe, PRC., Buckley, JD., et al.[2018]

In a study of 6,630 older adults at risk of cognitive decline, those who consumed 3 to 7 servings of nuts per week showed significant improvements in general cognitive function over 2 years compared to those who ate less than 1 serving per week.

Frequent nut consumption was linked to a smaller decline in cognitive performance, suggesting that incorporating nuts into the diet may benefit cognitive health in older adults, although further randomized clinical trials are needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher versus lower nut consumption and changes in cognitive performance over two years in a population at risk of cognitive decline: a cohort study. Ni, J., Nishi, SK., Babio, N., et al.[2023]

In a study involving 50 adults, consuming 28 g of peanuts daily for 6 weeks led to a significant increase in the abundance of the gut bacteria Ruminococcaceae, which are known to produce beneficial butyrate.

Metatranscriptomic analysis revealed increased expression of a gene associated with butyrate production after peanut intake, suggesting that peanuts can positively modulate gut microbiota and potentially improve gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peanuts as a nighttime snack enrich butyrate-producing bacteria compared to an isocaloric lower-fat higher-carbohydrate snack in adults with elevated fasting glucose: A randomized crossover trial. Sapp, PA., Kris-Etherton, PM., Arnesen, EA., et al.[2022]

Peanut allergy is a significant health concern, with its prevalence increasing 3.5-fold over the past 20 years, affecting 1.4-2% of people in Europe and the United States.

Management of peanut allergy has traditionally relied on strict avoidance of peanuts and emergency treatments, highlighting the challenges faced by allergic individuals and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

White paper on peanut allergy - part 1: Epidemiology, burden of disease, health economic aspects. Lange, L., Klimek, L., Beyer, K., et al.[2022]

In a study involving 118 adults over 4 weeks, different forms and processing methods of peanuts (like raw, roasted, and peanut butter) did not negatively affect body weight or fasting plasma lipid levels, suggesting they are safe for consumption.

Participants with elevated fasting plasma lipids experienced significant improvements in cholesterol levels, indicating that peanuts can have beneficial effects on heart health regardless of their form or processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of peanut processing on body weight and fasting plasma lipids. McKiernan, F., Lokko, P., Kuevi, A., et al.[2022]

A pooled analysis of four U.S. studies found that high nut consumption is associated with a 35% reduced risk of coronary heart disease (CHD), particularly lowering the risk of sudden cardiac death.

Nuts and peanuts not only improve cholesterol levels but also contain various bioactive compounds and nutrients that contribute to their cardiovascular benefits, suggesting that regular inclusion in a healthy diet could significantly lower CHD risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of tree nuts and peanuts in the prevention of coronary heart disease: multiple potential mechanisms. Kris-Etherton, PM., Hu, FB., Ros, E., et al.[2023]

In a study involving 63 healthy young adults, regular consumption of skin roasted peanuts (SRP) and peanut butter (PB) for six months significantly improved immediate memory and reduced anxiety scores compared to a control group consuming peanut oil-based butter.

The positive effects on memory and stress response were linked to the intake of peanut polyphenols and changes in gut health markers, such as increased levels of short-chain fatty acids (SCFAs).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of peanut products improves memory and stress response in healthy adults from the ARISTOTLE study: A 6-month randomized controlled trial. Parilli-Moser, I., Domínguez-López, I., Trius-Soler, M., et al.[2022]

The expert panel identified critical unmet needs in peanut allergy management, including the need for better implementation of early peanut introduction to prevent the allergy's development.

There is a need for improved education on the safety and efficacy of current and emerging immunotherapies, as well as better understanding of exposure risks and access to epinephrine for severe reactions, to support evidence-based treatment decisions for peanut-allergic individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unmet needs of children with peanut allergy: Aligning the risks and the evidence. Chan, ES., Dinakar, C., Gonzales-Reyes, E., et al.[2020]

Peanut allergies can lead to cross-reactivity with other legumes and tree nuts, making it essential for healthcare providers to carefully assess a patient's dietary history and potential allergies to other foods.

While molecular diagnostic testing may help identify cross-sensitization patterns, oral food challenges remain the most reliable method for diagnosing food allergies, and current desensitization treatments for peanut allergies do not address allergies to other legumes or tree nuts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing Cross-Reactivity in Those with Peanut Allergy. Chan, ES., Greenhawt, MJ., Fleischer, DM., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5762129/

Nut Consumption and Risk of Cardiovascular Disease - PMC Consumption of peanuts and tree nuts (two or more times/week) and walnuts (one or more times/week), was associated with a 13%-19% lower risk of total ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9011914/

Effect of Peanut Consumption on Cardiovascular Risk ... Although numerous studies have reported the protective effect of nut consumption on cardiovascular risk, evidence for the role of peanuts in ...

3. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.120.031212

Peanut Consumption and Risk of Stroke and Ischemic ... Higher peanut consumption was associated with reduced risks of total stroke, ischemic stroke, and cardiovascular disease among men and women.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323000686

Consumption of Nuts and Seeds and Health Outcomes ... An intake of 28 g/d nuts compared with not eating nuts was associated with a 21% RR reduction of cardiovascular disease (including coronary heart disease ...

5. withpower.com withpower.com/trial/phase-cardiovascular-diseases-8-2022-62a02

Peanuts for Brain and Heart Health · Info for Participants A meta-analysis of 13 randomized controlled trials found that peanut consumption does not significantly affect various cardiovascular disease (CVD) risk factors ...

6. heart.org heart.org/en/news/2021/09/09/just-4-or-5-peanuts-a-day-may-lower-stroke-risk-in-japanese-adults

Just 4 or 5 peanuts a day may lower stroke risk in ... People who ate four to five peanuts per day had a 20% lower risk of having a blood clot-related stroke and a 16% lower risk of having any type of stroke.

7. mayoclinic.org mayoclinic.org/diseases-conditions/heart-disease/in-depth/nuts/art-20046635

Nuts and your heart: Eating nuts for heart health Research has found that frequently eating nuts lowers levels of inflammation related to heart disease and diabetes.

8. foxnews.com foxnews.com/health/common-food-allergy-plummets-nationwide-after-experts-recommend-bold-new-approach

Early peanut introduction cuts allergies by 43% in kids ... Some experts say parents can now safely introduce peanuts to babies as early as 4 months, as a study finds that early exposure cuts food ...