MicrobiotaARISTOTLENCT04324749
Healthy Prebiotic and Postbiotic Effects of Peanuts and Peanut Butter: College Intervention Trial
A study testing Roasted peanuts (group A) and Peanut butter (group B) in people with Microbiota and Cognitive Change, run by University of Barcelona at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota, Cognitive Change
- What is being tested?
- Roasted peanuts (group A) and Peanut butter (group B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 18 Nov 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy college students (aged between 18 and 32 years)
Who cannot join
- 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
Show all 9Show fewer
- Alcohol intake (>30 g/day in males and >20 g/day in females)
- Smokers
- BMI <18.5 or >25
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Nutrition, Food Sciences and Gastronomy. School of Farmacy and Food Sciences. University of Barcelona.
Barcelona, 08028
About this study
Official title: 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.
Read the 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.
- Conditions
- Microbiota, Cognitive Change
- Being tested
- Roasted peanuts (group A), Peanut butter (group B), Control (group C)
- Keywords
- peanuts, peanut butter, microbiota, cognitive skills, polyphenols, short-chain fatty acids, inflammation, vascular
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (roasted peanuts) | Experimental | Group A: Habitual diet + 25 g/day of whole skin roasted peanuts (RP) Receives: Other: Roasted peanuts (group A) |
| Group B (peanut butter) | Experimental | Group B: Habitual diet+ 2 tbsp/day (32 g/day) of peanut butter (PB) Receives: Other: Peanut butter (group B) |
| Group C (control) | Experimental | Group C: Habitual diet + 2 tbsp/day (32 g/day) of control supplement Receives: Other: Control (group C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Body mass index (kg/m^2) are calculated after measure weight (kg) and height (meter).
Measured: 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
To evaluate waist-to-hip ratio, waist and hip circumferences (cm) are measured in triplicate
Measured: 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
Total adiposity are measured by bioelectrical impedance (percentage of fat).
Measured: 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
Systolic and diastolic blood pressure (mmHg) are measured with an automatic blood pressure monitor in triplicate.
Measured: 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
Heart rate (bpm) is measured with an automatic monitor in triplicate.
Measured: 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
Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mg/dL) are measured by molecular absorption spectrometry.
Measured: 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
Glucose (mg/dL) is measured by molecular absorption spectrometry.
Measured: 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
Cortisol (nmol/l) is measured by immunochemiluminescence
Measured: 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
Cytokines (pg/mL), tumor necrosis factor α (TNF-α) (pg/mL) and C-reactive protein (CRP) (mg/dL) will be assayed by immunoenzymatic methods.
Measured: Baseline and after completed the intervention (6 months)
Changes in nutrients and energy intake after regular peanut and peanut butter consumption in healthy college
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).
Measured: Baseline and after completed the intervention (6 months)
Changes in physical activity after regular peanut and peanut butter consumption in healthy college
Physical activity is measured by the validated Spanish version of the Minnesota Leisure-Time Physical Activity Questionnaire (Elosua et al., 1994).
Measured: Baseline and after completed the intervention (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start18 Nov 2019
- Primary completion18 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- The Peanut Institute
- Responsible party
- Principal investigator, Rosa M Lamuela-Raventós, University of Barcelona
- Investigators
- Rosa M Lamuela Raventós, PhD, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324749
- Sponsor's protocol ID
- 002501
- Acronym
- ARISTOTLE
- Status last verified
- Jul 2021
- First submitted
- 7 Feb 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dominguez-Lopez I, Eichelmann F, Parilli-Moser I, Hurtado-Barroso S, Lamuela-Raventos RM, Schulze MB. Peanuts-derived plasma lipids and lower risk of type-2 diabetes: Association mediated by body mass index. An intervention and case-cohort study. Am J Clin Nutr. 2026 Sep 17:101527. doi: 10.1016/j.ajcnut.2026.101527. Online ahead of print.
PubMed 42754169
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Prebiotic and Postbiotic Effects of Peanuts and Peanut Butter: College Intervention Trial (ARISTOTLE Study)
- ClinicalTrials.gov ID
- NCT04324749
- Acronym / sponsor ID
- ARISTOTLE / 002501
- Conditions
- Microbiota, Cognitive Change
- Keywords
- peanuts, peanut butter, microbiota, cognitive skills, polyphenols, short-chain fatty acids, inflammation, vascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- The Peanut Institute
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Group A (roasted peanuts) | Experimental | Other: Roasted peanuts (group A)Group A: Habitual diet + 25 g/day of whole skin roasted peanuts (RP) |
| Group B (peanut butter) | Experimental | Other: Peanut butter (group B)Group B: Habitual diet+ 2 tbsp/day (32 g/day) of peanut butter (PB) |
| Group C (control) | Experimental | Other: Control (group C)Group C: Habitual diet + 2 tbsp/day (32 g/day) of control supplement |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy college students (aged between 18 and 32 years)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group A (roasted peanuts) |
| 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. | Other | Group B (peanut butter) |
| 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. | Other | Group C (control) |
Primary outcome
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).
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).
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.
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.
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.
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.
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.
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.
11 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Changes in physical activity after regular peanut and peanut butter consumption in healthy college
Time frame: Baseline and after completed the intervention (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Derived from this study: PubMed 42754169Dominguez-Lopez I, Eichelmann F, Parilli-Moser I, Hurtado-Barroso S, Lamuela-Raventos RM, Schulze MB. Peanuts-derived plasma lipids and lower risk of type-2 diabetes: Association mediated by body mass index. An intervention and case-cohort study. Am J Clin Nutr. 2026 Sep 17:101527. doi: 10.1016/j.ajcnut.2026.101527. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa M Lamuela Raventós, PhD principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roasted peanuts (group A) and Peanut butter (group B) in people with Microbiota and Cognitive Change, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324749, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.