Peanut Butter for Imbalance of Microbes

Overseen By Cole Patoine, MS, RDN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Must not be taking: Antibiotics, Prebiotics, Probiotics, Postbiotics

Disqualifiers: Food allergies, Gastrointestinal disease, Neurological, Endocrine, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of daily smooth peanut butter consumption on gut and metabolic health in children aged 6-13. Researchers aim to determine whether peanut butter can improve gut function, affect metabolic and inflammatory markers, and serve as a feasible part of a healthy diet for kids. Participants will be divided into two groups: one will eat peanut butter with crackers, and the other will consume a chocolate spread with crackers. Children without allergies to peanuts, chocolate, or wheat, and who have not recently used antibiotics or probiotics, may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding dietary impacts on children's health.

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 taken antibiotics or pre/pro/postbiotics in the last 3 months, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that peanut butter is generally safe for most people. Made entirely from peanuts, it contains no added fillers or sugars. However, some risks exist. Peanut butter can occasionally be contaminated with harmful bacteria like Salmonella or contain toxins called aflatoxins. These issues are rare but important to consider, especially for children.

Many people consume peanut butter regularly without problems. Since this trial tests a common food product rather than a new drug, the safety concerns are lower than with typical medications. The trial uses smooth peanut butter, already part of many diets.

In summary, while peanut butter is mostly safe, awareness of rare contamination risks is wise. These are the main safety points to consider for those thinking about joining the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using smooth peanut butter for microbial imbalance because it introduces a natural, food-based approach to modifying gut health. Unlike traditional treatments that might involve probiotics or antibiotics, smooth peanut butter offers a unique source of healthy fats and nutrients that can support beneficial bacteria in the gut. This method integrates seamlessly into a daily diet, making it an easy and appealing option for individuals seeking to improve their gut microbial balance.

What evidence suggests that smooth peanut butter might be an effective treatment for gut and metabolic health in children?

Research has shown that regularly eating smooth peanut butter can benefit gut health. Peanuts contain prebiotic fiber and polyphenols, which support beneficial gut bacteria. Studies have found that consuming peanuts can alter gut function, indicating a healthier gut environment. In this trial, participants in the Peanut Butter Condition will supplement their normal diet with smooth peanut butter. This natural approach might improve gut health in children. Early findings also suggest that adding peanut butter to the diet could support overall health by reducing inflammation and enhancing well-being. ^{1 2 3 6 7}

Who Is on the Research Team?

Ravinder Nagpal, Ph.D.

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This trial is for children aged 6-13 who may have an imbalance of microbes in their gut. They should be able to eat peanut butter and not have any allergies or conditions that would interfere with the study, like a nut allergy or metabolic disorders.

Inclusion Criteria

Ability to speak and read in English

I am a student in grades 1-8.

I am between 6 and 13 years old.

Exclusion Criteria

I have not taken antibiotics in the last 3 months.

Intake of pre/pro/postbiotics in the last 3 months

Food allergy to study foods (nuts, peanuts, chocolate, or wheat)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume either peanut butter or a control snack daily for eight weeks to assess effects on gut and metabolic health

8 weeks

3 visits (in-person) at baseline, midpoint, and endpoint

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smooth Peanut Butter

Trial Overview The study tests if eating smooth peanut butter every day can improve kids' gut health and metabolism. One group eats peanut butter on crackers; the other has a chocolate spread on crackers instead. The effects are compared after eight weeks.

How Is the Trial Designed?

Group I: Peanut Butter Condition Experimental Treatment 1 Intervention

Peanut Butter (PB) Group: This condition involves a normal diet supplemented daily with a personalized portion of smooth peanut butter (Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter) sandwiched between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers). There is a limit of 16g of peanut butter per two crackers. The quantity of peanut butter provided daily will be equivalent to 20% of each participant's individual daily caloric intake. These caloric needs will be established using Dietary Guidelines for Americans (DGA) based on the participant's age and gender.

Group II: Control Snack Condition Active Control 1 Intervention

Control (CTL) Group: This condition includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread (Cadbury Milk Chocolate) also sandwiched between two plain unsalted saltine crackers (Unsalted Tops Premium Saltine Crackers), with the same 16g limit per two crackers. The quantity of chocolate spread provided daily will be equivalent to 20% of each participant's individual daily caloric intake. These caloric needs will be established using Dietary Guidelines for Americans (DGA) based on the participant's age and gender

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

The Peanut Institute

Collaborator

Trials

7

Recruited

350+

Published Research Related to This Trial

A hypoallergenic variant of the peanut allergen Ara h 2 was successfully created by removing both conformational and linear IgE-binding epitopes, significantly reducing its ability to bind IgE and cause allergic reactions.

This modified Ara h 2 showed low basophil activation and did not induce anaphylaxis in sensitized mice, indicating its potential as a safe allergen-specific immunotherapy for peanut allergy while still retaining T-cell activation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a novel Ara h 2 hypoallergen with no IgE binding or anaphylactogenic activity. Tscheppe, A., Palmberger, D., van Rijt, L., et al.[2021]

In a 6-month phase 3 trial involving 506 children with peanut allergies, PTAH (peanut allergen powder-dnfp) demonstrated a safety profile similar to that observed in previous trials that required double-blind, placebo-controlled food challenges (DBPCFCs).

The most common treatment-emergent adverse events (AEs) were mild to moderate gastrointestinal issues, with 55% of PTAH participants experiencing at least one AE compared to 33.9% for placebo, indicating that while AEs were common, they were generally not severe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant characteristics and safety outcomes of peanut oral immunotherapy in the RAMSES and ARC011 trials. Ciaccio, C., Goldsobel, AB., Anagnostou, A., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06916936?draw=2&rank=1

Effect of Peanut Butter on Gut and Metabolic Health Research Intervention(s): Researchers compare two groups to see if there really is an effect of daily smooth peanut butter intake on gut and metabolic health.

2. withpower.com withpower.com/trial/peanut-butter-for-imbalance-of-microbes-f01b7

Peanut Butter for Imbalance of Microbes Smooth peanut butter as a treatment for microbial imbalance is unique because it is a food-based approach, potentially offering a more natural and accessible ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11478729/

Influence of Peanut Consumption on the Gut Microbiome Peanut intervention was significantly associated with reduced enrichment of 24 gut microbial metabolic pathways after FDR correction (FDR < 0.1).

4. crazyrichards.com crazyrichards.com/product/creamy-peanut-butter/

Creamy Peanut Butter Our all-natural peanut butter is made from 100% US grown peanuts. No additives, fillers, salts or sugars!

5. peanut-institute.com peanut-institute.com/new-gut-microbiome-research-points-to-positive-impact-on-memory-and-mood/

New Gut Microbiome Research Points to Positive Impact ... “Peanuts and peanut butter may have a beneficial effect on the gut microbiota because they are rich in prebiotic fiber and polyphenols,” says Dr. Isabella ...

6. healthyheartmarket.com healthyheartmarket.com/products/crazy-richards-100-peanuts-creamy-peanut-butter-16oz?srsltid=AfmBOoqxOXbvVqJOzC5egW8BVqhNF2YCMCMJQfDlz-Ru7wg117YrZMoy

Crazy Richard's 100% Peanuts Creamy Peanut Butter - 16oz. Crazy Richard's 100% Peanuts! Natural Peanut Butter is plant based, has no palm oil, contains no salt, no sugar added, gluten free, and made in the USA.

7. amazon.com amazon.com/Crazy-Richards-All-Natural-Crunchy-Variety/dp/B0B1JNCDM5

Crazy Richard's 100% All-Natural Vegan Creamy & ... 100% Peanuts Creamy Texture and Consistency: We double-grind our peanuts to get rid of any grit for the smoothest Creamy PB around. No added oils means our ...