Peanut Butter and Gut Health in Children
This study is looking at how eating peanut butter every day affects the gut and overall health of children aged 6 to 13. We want to see if daily snacks of "Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter" can improve gut health, including the types of bacteria in the gut (gut microbiome diversity) and how the body processes food (fecal metabolome). Some children will eat peanut butter, while others will have a chocolate spread as a comparison. We'll measure these changes over eight weeks. To join, children must be in grades 1-8, speak English, and not have certain allergies or have taken antibiotics recently. The study is currently unclear on its recruitment status, but plans to enroll 60 children.
- Study design
- This is a randomized study, meaning participants are assigned by chance to either the peanut butter group or the chocolate spread group. It plans to enroll 60 children.
- What's involved
- Participants will receive a daily snack for eight weeks. They will have measurements taken at the beginning, middle (week 4), and end (week 8) of the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for eight weeks, with measurements taken at baseline, week 4, and week 8.
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Effect of Peanut Butter on Gut and Metabolic Health
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ravinder Nagpal, Ph.D. · PRINCIPAL_INVESTIGATOR · Florida State University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Gut Microbiome DiversityBaseline (day 0) Midpoint (week 4), and endpoint (week 8)
Collected fecal samples will be used to determine microbiome profiles, including diversity and composition of bacteria.
- Change in Oral Microbiome DiversityBaseline (day 0), Endpoint (week 8)
Oral swab samples are collected to determine oral diversity and composition of bacteria in the mouth before and after intervention.
- Change in Fecal MetabolomeBaseline (day 0) and Endpoint (week 8)
The endpoint of fecal metabolomics will be assessed by collecting fecal samples from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the feces. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular peanut butter intake affects metabolic processes and gut health.
- Change in Serum MetabolomeBaseline (day 0), and Endpoint (week 8).
The endpoint of serum metabolomics will be assessed by collecting blood serum from participants at the beginning and end of the study. These samples will be analyzed using advanced techniques, such as mass spectrometry, to identify and quantify various metabolites present in the serum. The changes in the levels of specific metabolites, which can reflect shifts in gut microbiome composition and metabolic health, will be compared between pre- and post-intervention periods. This analysis will help determine how regular peanut butter intake affects metabolic processes and gut health.