Healthy Prebiotic and Postbiotic Effects of Peanuts and Peanut Butter: College Intervention Trial (ARISTOTLE)

University of Barcelona

Status: Completed

Conditions: Cognitive Change; Microbiota

Treatments: Other: Peanut butter (group B); Other: Roasted peanuts (group A); Other: Control (group C)

Study type: Interventional

Funder types: Other

Identifiers

NCT04324749

002501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 32 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Group A (roasted peanuts)

Experimental group

Description:

Group A: Habitual diet + 25 g/day of whole skin roasted peanuts (RP)

Treatment:

Other: Roasted peanuts (group A)

Group B (peanut butter)

Experimental group

Description:

Group B: Habitual diet+ 2 tbsp/day (32 g/day) of peanut butter (PB)

Treatment:

Other: Peanut butter (group B)

Group C (control)

Experimental group

Description:

Group C: Habitual diet + 2 tbsp/day (32 g/day) of control supplement

Treatment:

Other: Control (group C)