Healthy Prebiotic and Postbiotic Effects of Peanuts and Peanut Butter: College Intervention Trial (ARISTOTLE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Changes in the intelligence and cognitive ability in healthy college students after a daily intake of peanuts and peanut butter
研究概览
简要总结
Nuts have a prebiotic effect mainly due to their content of fiber and polyphenols, which provide substrates for the human gut microbiota. It is known that prebiotic substances are metabolized by microbiota generating postbiotics substances (products or metabolic by-products secreted by live bacteria or released after bacterial lysis). These products may improve host health and partly explain the health benefits of nut consumption. However, no study has been performed about the pre- and postbiotic effects of peanut and peanut butter consumption. Therefore, researchers propose a new interventional study to assess the impact of daily peanut and peanut butter intake on the organism, evaluating the pre- and postbiotic effects. The metabolome data generated will be correlated with the beneficial effects and cognitive skills. The final aim of this work is to spread a message of the health benefits of peanut consumption for the general population.
详细描述
To evaluate the possible changes in microbiota and cognitive skills after consumption of roasted peanuts and peanut butter, a three-arm parallel-group randomized, and controlled study is being carried out. Ninety healthy college students were enrolled, according to the sample size estimated. Blood, urine, feces and saliva are being drawing at baseline, 3 and 6 months. Peripheral blood mononuclear cells are being extracted to evaluate the metabolic changes caused by the proposed nutritional interventions. To assess diet and physical activity a 151-items food frequency questionnaire plus a 7-day dietary record and a validated questionnaire Minnesota are being used. To determinate the effects of the intervention on body composition and vascular risk factors, anthropometric, biochemical and clinical measurements are being collected. Possible changes in cognitive skills will be determined from a validated cognitive questionnaire (WAIS-IV, Wechsler Memory Scale-IV (WMS-IV), COPE and HAD). To evaluate inflammation and metabolic status before and after intervention, levels of hormones and signaling molecules will be analyzed in blood samples. The effect of roasted peanut and peanut butter consumption on microbiota will be assayed through identification and quantification of polyphenols and short-chain fatty acids in biological samples, as well as the gut microbiota characterization from DNA extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 32 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy college students (aged between 18 and 32 years)
排除标准
- •History of pathological conditions (cardiovascular diseases, cancer, diabetes and other chronic diseases)
- •Alteration of clinical parameters (cholesterol, triglycerides and other markers)
- •Peanut allergy or intolerance
- •Use of dietary supplements or drugs
- •Unusual dietary habits
- •Usual consumption of wine and grapes
- •Alcohol intake (>30 g/day in males and >20 g/day in females)
- •BMI <18.5 or >25
结局指标
主要结局
Changes in the intelligence and cognitive ability in healthy college students after a daily intake of peanuts and peanut butter
时间窗: Baseline and after completed the intervention (6 months)
To measure intelligence and cognitive ability, the Wechsler Adult Intelligence Scale IV (WAIS IV) will be used.
Changes in language and executive function in healthy college students after a daily intake of peanuts and peanut butter
时间窗: Baseline and after completed the intervention (6 months)
To measure language and executive function, lexical fluency tests will be used.
Changes in the short-chain fatty acids after a daily intake of peanuts and peanut butter in biological samples of healthy college students
时间窗: Baseline and after completed the intervention (6 months)
After acidifying the fecal samples with formic acid, a quantification of short-chain fatty acids will be performed using gas chromatography by direct injection according to previously described methodology (Zhao et al., 2006).
Changes in the polyphenols and their metabolites after a daily intake of peanuts and peanut butter in biological samples of healthy college students
时间窗: Baseline and after completed the intervention (6 months)
Identification and quantification of polyphenols will be determined using a high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS) method (Sasot et al., 2017) and quantified by ultra high-performance liquid chromatography coupled with triple quadrupole mass spectrometry (UHPLC-QqQ-MS/MS) methodology (Martínez-Huélamo et al., 2015).
Changes in the gut microbiota after a daily intake of peanuts and peanut butter in fecal samples of healthy college students
时间窗: Baseline and after completed the intervention (6 months)
Fecal samples will be collected by the volunteers using a system for easy self-collection and stabilization of microbial DNA for gut microbiome profiling (OMNIgene - GUT). The genomic DNA will be extracted from fecal samples using the DNeasy PowerSoil Kit. Then, the 16s metagenomic analysis will be performed.
Changes in the memory function in healthy college students after a daily intake of peanuts and peanut butter
时间窗: Baseline and after completed the intervention (6 months)
To measure memory function, the Wechsler Memory Scale IV (WSM IV) will be used.
Changes in cope to stressful situations in healthy college students after a daily intake of peanuts and peanut butter
时间窗: Baseline and after completed the intervention (6 months)
The 48-items Coping Orientation to Problems Experienced questionnaire (COPE-48) will be performed to assay how healthy college students cope with highly demanding situations demanding situations of healthy college students.
Changes in levels of anxiety and depression in healthy college students after a daily intake of peanuts and peanut butter
时间窗: Baseline and after completed the intervention (6 months)
To measure the levels of anxiety and depression of healthy college students the Hospital Anxiety and Depression Scale (HAD) will be used.
次要结局
- Changes in body mass index after a daily intake of peanuts and peanut butter in healthy college students(Baseline, 3 months and after completed the intervention (6 months))
- Changes in blood pressure after a daily intake of peanuts and peanut butter in healthy college students(Baseline, 3 months and after completed the intervention (6 months))
- Changes in glucose after a daily intake of peanuts and peanut butter in healthy college students(Baseline, 3 months and after completed the intervention (6 months))
- Changes in pro- and anti-inflammatory biomarkers after a daily intake of peanuts and peanut butter in healthy college(Baseline and after completed the intervention (6 months))
- Changes in lipidic profile after a daily intake of peanuts and peanut butter in healthy college students(Baseline, 3 months and after completed the intervention (6 months))
- Changes in waist-to-hip ratio after a daily intake of peanuts and peanut butter in healthy college students(Baseline, 3 months and after completed the intervention (6 months))
- Changes in percentage of body fat after a daily intake of peanuts and peanut butter in healthy college students(Baseline, 3 months and after completed the intervention (6 months))
- Changes in heart rate after a daily intake of peanuts and peanut butter in healthy college students(Baseline, 3 months and after completed the intervention (6 months))
- Changes in cortisol after a daily intake of peanuts and peanut butter in healthy college(Baseline, 3 months and after completed the intervention (6 months))
- Changes in nutrients and energy intake after regular peanut and peanut butter consumption in healthy college(Baseline and after completed the intervention (6 months))
- Changes in physical activity after regular peanut and peanut butter consumption in healthy college(Baseline and after completed the intervention (6 months))
研究者
Rosa M Lamuela-Raventós
Rosa M Lamuela-Raventós, Professor, University of Barcelona
University of Barcelona