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

July 28, 2021 updated by: Rosa M Lamuela-Raventós, University of Barcelona

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Department of Nutrition, Food Sciences and Gastronomy. School of Farmacy and Food Sciences. University of Barcelona.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 32 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A (roasted peanuts)
Group A: Habitual diet + 25 g/day of whole skin roasted peanuts (RP)
Other: Roasted peanuts (group A)
After 2 weeks following a peanut-free diet, the participants of this group consume 25 g/ day of whole skin roasted peanuts (RP) within the habitual diet during 6 months.
Experimental: Group B (peanut butter)
Group B: Habitual diet+ 2 tbsp/day (32 g/day) of peanut butter (PB)
Other: Peanut butter (group B)
After 2 weeks following a peanut-free diet, the participants of this group consume 2 tbsp/ day (32 g/ day) of peanut butter (PB) within the habitual diet during 6 months.
Experimental: Group C (control)
Group C: Habitual diet + 2 tbsp/day (32 g/day) of control supplement
Other: Control (group C)
After 2 weeks following a peanut-free diet, the participants of this group consume 2 tbsp/ day (32 g/ day) of control supplement (containing the same proportion of macronutrients as peanuts and peanut butter) within the habitual diet during 6 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in the polyphenols and their metabolites after a daily intake of peanuts and peanut butter in biological samples of healthy college students
Time Frame: 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).
Baseline and after completed the intervention (6 months)
Changes in the short-chain fatty acids after a daily intake of peanuts and peanut butter in biological samples of healthy college students
Time Frame: 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).
Baseline and after completed the intervention (6 months)
Changes in the gut microbiota after a daily intake of peanuts and peanut butter in fecal samples of healthy college students
Time Frame: 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.
Baseline and after completed the intervention (6 months)
Changes in the intelligence and cognitive ability in healthy college students after a daily intake of peanuts and peanut butter
Time Frame: 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.
Baseline and after completed the intervention (6 months)
Changes in the memory function in healthy college students after a daily intake of peanuts and peanut butter
Time Frame: Baseline and after completed the intervention (6 months)
To measure memory function, the Wechsler Memory Scale IV (WSM IV) will be used.
Baseline and after completed the intervention (6 months)
Changes in language and executive function in healthy college students after a daily intake of peanuts and peanut butter
Time Frame: Baseline and after completed the intervention (6 months)
To measure language and executive function, lexical fluency tests will be used.
Baseline and after completed the intervention (6 months)
Changes in cope to stressful situations in healthy college students after a daily intake of peanuts and peanut butter
Time Frame: 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.
Baseline and after completed the intervention (6 months)
Changes in levels of anxiety and depression in healthy college students after a daily intake of peanuts and peanut butter
Time Frame: 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.
Baseline and after completed the intervention (6 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in body mass index after a daily intake of peanuts and peanut butter in healthy college students
Time Frame: Baseline, 3 months and after completed the intervention (6 months)
Body mass index (kg/m^2) are calculated after measure weight (kg) and height (meter).
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
Time Frame: Baseline, 3 months and after completed the intervention (6 months)
To evaluate waist-to-hip ratio, waist and hip circumferences (cm) are measured in triplicate
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
Time Frame: Baseline, 3 months and after completed the intervention (6 months)
Total adiposity are measured by bioelectrical impedance (percentage of fat).
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
Time Frame: Baseline, 3 months and after completed the intervention (6 months)
Systolic and diastolic blood pressure (mmHg) are measured with an automatic blood pressure monitor in triplicate.
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
Time Frame: Baseline, 3 months and after completed the intervention (6 months)
Heart rate (bpm) is measured with an automatic monitor in triplicate.
Baseline, 3 months and after completed the intervention (6 months)
Changes in lipidic profile after a daily intake of peanuts and peanut butter in healthy college students
Time Frame: Baseline, 3 months and after completed the intervention (6 months)
Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mg/dL) are measured by molecular absorption spectrometry.
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
Time Frame: Baseline, 3 months and after completed the intervention (6 months)
Glucose (mg/dL) is measured by molecular absorption spectrometry.
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
Time Frame: Baseline, 3 months and after completed the intervention (6 months)
Cortisol (nmol/l) is measured by immunochemiluminescence
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
Time Frame: Baseline and after completed the intervention (6 months)
Cytokines (pg/mL), tumor necrosis factor α (TNF-α) (pg/mL) and C-reactive protein (CRP) (mg/dL) will be assayed by immunoenzymatic methods.
Baseline and after completed the intervention (6 months)
Changes in nutrients and energy intake after regular peanut and peanut butter consumption in healthy college
Time Frame: Baseline and after completed the intervention (6 months)
Dietary changes are evaluated with a 151-item semi-quantitative food frequency questionnaire (Fernández-Ballart et al., 2010). In addition, a 7-day food recall on the day of the intervention are used to validated this results. These were analyzed using a software called Programa de Càlcul Nutricional Professional (PCN Pro).
Baseline and after completed the intervention (6 months)
Changes in physical activity after regular peanut and peanut butter consumption in healthy college
Time Frame: Baseline and after completed the intervention (6 months)
Physical activity is measured by the validated Spanish version of the Minnesota Leisure-Time Physical Activity Questionnaire (Elosua et al., 1994).
Baseline and after completed the intervention (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Barcelona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Peanut Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rosa M Lamuela Raventós, PhD, University of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 18, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 002501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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