Peanut Consumption on Cognitive, Weight, and Inflammation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-12
SponsorUniversity of Barcelona
About this trial
A multi-school, two-arm parallel cluster-randomized controlled trial will be conducted in 200 healthy young adolescents from Barcelona (Spain) to evaluate the effect of peanut consumption on cognitive performance, weight management and inflammation. Schools willing to participate will be randomly assigned to either the intervention or the control group. After the recruitment, the participants will follow a peanut-free diet for two weeks. Both arms will receive a multidimensional educational intervention designed by the Gasol Foundation to promote healthy dietary habits based on Mediterranean diet recommendations, along with exercise performance, healthy sleeping habits and emotional knowledge. Half of the participants (intervention group) will consume 25 g of whole skin roasted peanuts as a daily snack to be incorporated into their diet for six months.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Food (peanut)
Other interventionAfter the recruitment, the participants will follow a peanut-free diet for two weeks.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Peanuty groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Changes in the depression score in healthy young adolescents after a daily intake of peanuts.
To measure depression score, the CDI Childhood Depression Inventory test will be used.
Time frame
Baseline and after 6 months2
Changes in the ability to concentrate, selective attention and processing speed in healthy young adolescents after a daily intake of peanuts.
To measure the ability to concentrate, selective attention and processing speed, the d2-R Attention Test (Revised) will be used.
Time frame
Baseline and after 6 months3
Changes in assessment of interference and cognitive control in healthy young adolescents after a daily intake of peanuts.
To measure the assessment of interference and cognitive control, the Stroop test will be used.
Time frame
Baseline and after 6 months4
Changes in processing speed, attention span and working memory in healthy young adolescents after a daily intake of peanuts.
To measure processing speed, attention span and working memory, the WISC-V Digits and Codes Subtest will be used.
Time frame
Baseline and after 6 monthsSecondary outcomes
1
Changes in waist circumference after a daily intake of peanuts in healthy young adolescents
Change in waist circumference (cm) will be measured in triplicate
Time frame
Baseline, 3 and after 6 months2
Changes in blood pressure after a daily intake of peanuts in healthy young adolescents
Systolic and diastolic blood pressure (mmHg) will be measured using an automatic blood pressure monitor in triplicate.
Time frame
Baseline, 3 and after 6 months3
Changes in heart rate after a daily intake of peanuts in healthy young adolescents
Heart rate (bpm) is measured with an automatic monitor in triplicate.
Time frame
Baseline, 3 and after 6 months4
Changes in lipidic profile after a daily intake of peanuts in healthy young adolescents
Total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mg/dL) will be measured using a portable Cardiocheck analyzer, through 40 µL of capillary and fasting blood.
Time frame
Baseline and after 6 monthsSponsors and contacts
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University of Barcelona
Lead sponsor
Gasol Foundation
Collaborator
Universitat Oberta de Catalunya
Collaborator
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Collaborator
Source ClinicalTrials.gov