Effect of Peanut Butter on Gut and Metabolic Health in School-Aged Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Gut Microbiome Diversity
研究概览
简要总结
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)
- 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.
- 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:
- The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in elementary or middle school (grades 1-8)
- •Aged 6-13 years old
- •Ability to speak and read in English
排除标准
- •Intake of antibiotics in the last 3 months
- •Intake of pre/pro/postbiotics in the last 3 months
- •Food allergy to study foods
- •Any allergy to nuts or peanuts
- •Any allergy to the isocaloric snack (chocolate or wheat)
- •Regular consumption of nuts or peanuts greater than 2 servings / week
- •Gastrointestinal disease (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome, irritable bowel syndrome, gastroesophageal reflux disease), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C > 9%).
- •Known to be pregnant (self-disclosed)
研究组 & 干预措施
Peanut Butter Condition
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.
干预措施: Creamy Richards 100% Peanuts! Creamy Natural Peanut Butter (Other)
Control Snack Condition
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
干预措施: Cadbury Milk Chocolate Spread (Other)
结局指标
主要结局
Change in Gut Microbiome Diversity
时间窗: Baseline (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 Diversity
时间窗: Baseline (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 Metabolome
时间窗: Baseline (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 Metabolome
时间窗: Baseline (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.
次要结局
- Change in Habitual Dietary Intake(baseline (day 0), midpoint (week 4) and endpoint (week 8).)
- Change in Body Weight(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Urinary Melatonin(Baseline (day 0) Midpoint (week 4), endpoint (week 8).)
- Change in Urinary Serotonin(Baseline (day 0) Midpoint (week 4), endpoint (week 8).)
- Change in Body Fat Percentage(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Lipid Profiles(Baseline (day 0), endpoint (week 8))
- Change in Intracellular Fluid(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Extracellular Fluid(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Gut Transit Time(Baseline (day 0), and endpoint (week 8))
- Change in Waist / Hip Circumference(baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Biomarkers of Inflammation(Baseline (day 0), Endpoint (week 8))
- Change in Biomarkers of Intestinal Barrier Function(Baseline (day 0), endpoint (week 8).)
- Change in Lean Mass(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Biomarkers of Appetite(baseline (day 0), endpoint (week 8))
- Change in Rested, Seated Blood Pressure(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
- Change in Fasting Blood Glucose(Baseline (day 0), endpoint (week 8).)
- Dietary Adherence(Daily, baseline through endpoint (week 8))
- Change in Total Body Water(Baseline (day 0), midpoint (week 4), endpoint (week 8).)
研究者
Ravi Nagpal
Principal Investigator
Florida State University