Clinical trial NCT04324749: Healthy Prebiotic and Postbiotic Effects of Peanuts and Peanut Butter: College Intervention Trial
Official title: Healthy Prebiotic and Postbiotic Effects of Peanuts and Peanut Butter: College Intervention Trial (ARISTOTLE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiota
Cognitive Change
Keywords: peanuts
peanut butter
microbiota
cognitive skills
polyphenols
short-chain fatty acids
inflammation
vascular
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: The Peanut Institute
First posted: 2020-03-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: Habitual diet + 25 g/day of whole skin roasted peanuts (RP) Group B: Habitual diet+ 2 tbsp/day (32 g/day) of peanut butter (PB) Group C: Habitual diet + control supplement (containing the same proportion of macronutrients as in the intervention)
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

- Healthy college students (aged between 18 and 32 years)

Exclusion Criteria:

* 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)
* Smokers
* BMI \<18.5 or \>25

Primary outcomes:
measure: Changes in the polyphenols and their metabolites after a daily intake of peanuts and peanut butter in biological samples of healthy college students
timeFrame: Baseline and after completed the intervention (6 months)
measure: Changes in the short-chain fatty acids after a daily intake of peanuts and peanut butter in biological samples of healthy college students
timeFrame: Baseline and after completed the intervention (6 months)
measure: Changes in the gut microbiota after a daily intake of peanuts and peanut butter in fecal samples of healthy college students
timeFrame: Baseline and after completed the intervention (6 months)
measure: Changes in the intelligence and cognitive ability in healthy college students after a daily intake of peanuts and peanut butter
timeFrame: Baseline and after completed the intervention (6 months)
measure: Changes in the memory function in healthy college students after a daily intake of peanuts and peanut butter
timeFrame: Baseline and after completed the intervention (6 months)
measure: Changes in language and executive function in healthy college students after a daily intake of peanuts and peanut butter
timeFrame: Baseline and after completed the intervention (6 months)
measure: Changes in cope to stressful situations in healthy college students after a daily intake of peanuts and peanut butter
timeFrame: Baseline and after completed the intervention (6 months)
measure: Changes in levels of anxiety and depression in healthy college students after a daily intake of peanuts and peanut butter
timeFrame: Baseline and after completed the intervention (6 months)
Secondary outcomes:
measure: Changes in body mass index after a daily intake of peanuts and peanut butter in healthy college students
timeFrame: Baseline, 3 months and after completed the intervention (6 months)
measure: Changes in waist-to-hip ratio after a daily intake of peanuts and peanut butter in healthy college students
timeFrame: Baseline, 3 months and after completed the intervention (6 months)
measure: Changes in percentage of body fat after a daily intake of peanuts and peanut butter in healthy college students
timeFrame: Baseline, 3 months and after completed the intervention (6 months)
measure: Changes in blood pressure after a daily intake of peanuts and peanut butter in healthy college students
timeFrame: Baseline, 3 months and after completed the intervention (6 months)
measure: Changes in heart rate after a daily intake of peanuts and peanut butter in healthy college students
timeFrame: Baseline, 3 months and after completed the intervention (6 months)
measure: Changes in lipidic profile after a daily intake of peanuts and peanut butter in healthy college students
timeFrame: Baseline, 3 months and after completed the intervention (6 months)
measure: Changes in glucose after a daily intake of peanuts and peanut butter in healthy college students
timeFrame: Baseline, 3 months and after completed the intervention (6 months)
measure: Changes in cortisol after a daily intake of peanuts and peanut butter in healthy college
timeFrame: Baseline, 3 months and after completed the intervention (6 months)
measure: Changes in pro- and anti-inflammatory biomarkers after a daily intake of peanuts and peanut butter in healthy college
timeFrame: Baseline and after completed the intervention (6 months)
measure: Changes in nutrients and energy intake after regular peanut and peanut butter consumption in healthy college
timeFrame: Baseline and after completed the intervention (6 months)
measure: Changes in physical activity after regular peanut and peanut butter consumption in healthy college
timeFrame: Baseline and after completed the intervention (6 months)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Department of Nutrition, Food Sciences and Gastronomy. School of Farmacy and Food Sciences. University of Barcelona.
Study officials:
affiliation: University of Barcelona
name: Rosa M Lamuela Raventós, PhD
role: PRINCIPAL_INVESTIGATOR
References: