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

NCT04324749 | Completed DMC

• 1 other identifier: 002501
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiota; Cognitive Change

Keywords

peanuts; peanut butter; microbiota; cognitive skills; polyphenols; short-chain fatty acids; inflammation; vascular

Outcome Measures

Primary Outcomes (8)

• Changes in the polyphenols and their metabolites after a daily intake of peanuts and peanut butter in biological samples of healthy college students

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (11)

• 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 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 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 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)

Study Arms (3)

Group A (roasted peanuts)

EXPERIMENTAL

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

Other: Roasted peanuts (group A)

Group B (peanut butter)

EXPERIMENTAL

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

Other: Peanut butter (group B)

Group C (control)

EXPERIMENTAL

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

Other: Control (group C)

Interventions

Roasted peanuts (group A) OTHER

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.

Group A (roasted peanuts)

Peanut butter (group B) OTHER

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.

Group B (peanut butter)

Control (group C) OTHER

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.

Group C (control)

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Barcelona: lead
• The Peanut Institute: collaborator

Study Sites (1)

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

Barcelona, 08028, Spain

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rosa M Lamuela Raventós, PhD

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rosa M Lamuela-Raventós, Professor, University of Barcelona

Model Details: 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)

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: March 27, 2020
• Study Start: November 18, 2019
• Primary Completion: December 18, 2019
• Study Completion: June 30, 2020
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)