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

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

What data supports the effectiveness of the treatment Smooth Peanut Butter for Imbalance of Microbes?

Research on peanut-based therapeutic foods, like Plumpy'nut, shows they are used to treat malnutrition and are perceived to have therapeutic benefits, although taste and smell issues affect acceptability. This suggests that peanut-based products can have positive health effects, which might support their use in addressing microbial imbalances. ^{1 2 3 4 5}

Is peanut butter generally safe for human consumption?

Peanut butter can be safe for most people, but there are risks of contamination with harmful bacteria like Salmonella and toxins called aflatoxins, which are difficult to remove. Additionally, people with peanut allergies should avoid it, as even small amounts can cause allergic reactions. ^{6 7 8 9 10}

How does the treatment of smooth peanut butter differ from other treatments for microbial imbalance?

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 option compared to traditional medications. Unlike other treatments that may involve pharmaceuticals or supplements, peanut butter provides a source of dietary fats and proteins that could influence gut bacteria composition in a novel way. ^{11 12 13 14 15}

What is the purpose of this trial?

The goal of this is parallel arm, randomized clinical trial is to learn and understand the effect of daily smooth peanut butter consumption on gut and metabolic health of children age 6-13. The main objectives are: Primary Objective: To determine the prebiotic effect of daily smooth peanut butter consumption for eight weeks on gut health, including microbiome-metabolome arrays, gut epithelial/barrier function, and gut transit time, in school-aged children. Secondary Objective(s) 1. To determine the effect of daily smooth peanut butter consumption for eight weeks on metabolic and inflammatory health markers, and measures of sleep quality in school-aged children. 2. To determine the potential mechanisms and feasibility of incorporating peanut butter into the diets of school-aged children as part of healthy, personalized nutrition. 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. The two groups are: 1. The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers. 2. The 2nd condition (CTL) includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread, sandwiched between two plain unsalted saltine crackers.

Research Team

Ravinder Nagpal, Ph.D.

Principal Investigator

Florida State University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Effect of chemical modifications on allergenic potency of peanut proteins. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Reducing Oil Separation in Ready-to-Use Therapeutic Food. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Peanut-based ready-to-use therapeutic food: how acceptable and tolerated is it among malnourished pregnant and lactating women in Bangladesh? [2021]

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

Effect of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy: The PEPITES Randomized Clinical Trial. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Formulation of a drinkable peanut-based therapeutic food for malnourished children using plant sources. [2015]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Peanut Butter Food Safety Concerns-Prevalence, Mitigation and Control of Salmonella spp., and Aflatoxins in Peanut Butter. [2022]

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

Relevance of casual contact with peanut butter in children with peanut allergy. [2022]

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

Development of a novel Ara h 2 hypoallergen with no IgE binding or anaphylactogenic activity. [2021]

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

Participant characteristics and safety outcomes of peanut oral immunotherapy in the RAMSES and ARC011 trials. [2022]

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

Use of Radioimmunoassay to Determine the Nature, Quantity and Source of Allergenic Contamination of Sunflower Butter. [2023]

11. China pubmed.ncbi.nlm.nih.gov

[Quantitative analysis of dominating intestinal flora among groups of people with different body fat]. [2006]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Sporobakterin impact on atherogenic dyslipidemia at patients with intestinal dysbacteriosis]. [2010]

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

Human gut bacterial communities are altered by addition of cruciferous vegetables to a controlled fruit- and vegetable-free diet. [2023]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Interactions between Obesity Status and Dietary Intake of Monounsaturated and Polyunsaturated Oils on Human Gut Microbiome Profiles in the Canola Oil Multicenter Intervention Trial (COMIT). [2020]

15. England pubmed.ncbi.nlm.nih.gov

Effects of OsomeFood Clean Label plant-based meals on the gut microbiome. [2023]