Actively Recruiting

Phase Not Applicable
Age: 10Years - 12Years
All Genders
Healthy Volunteers
ID06127511

Peanut Consumption on Cognitive Performance, Weight Management, and Inflammation in Young Adolescents

Led by University of Barcelona · Updated on 2025-04-03

200

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of Barcelona

Lead Sponsor

G

Gasol Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a multi-school, two-arm parallel cluster-randomized controlled trial with 200 healthy young adolescents aged 10 to 12 years in Barcelona, Spain. The study aims to evaluate the effects of daily peanut consumption on cognitive performance, weight management, and inflammation. This research also includes an educational intervention promoting healthy dietary habits based on the Mediterranean diet, exercise, sleep, and emotional knowledge. The trial investigates how peanuts may influence brain function and overall health during adolescence, a key period for brain development and growth. Participants will first follow a peanut-free diet for two weeks before the study begins. Then, schools will be randomly assigned to either an intervention or control group. Both groups receive the educational program, but the intervention group will consume 25 grams of whole skin roasted peanuts daily as a snack for six months. Peanuts will be provided in monthly doses, and families will be supported with recipes and adherence monitoring. The control group will maintain usual care and avoid nut consumption during the study. Throughout the study, trained nurses and nutritionists will assess participants at baseline and after six months. Evaluations include cognitive tests measuring memory, attention, reasoning, and social cognition, as well as physical measurements like body composition, blood pressure, and biochemical markers related to inflammation and vascular health. Additional assessments cover diet, physical activity, sleep, pubertal development, and gut microbiota through biological samples. The researchers will track changes in depression scores, cognitive abilities, body mass index, and inflammatory biomarkers to understand peanut consumption's effects on adolescent health.

CONDITIONS

Brief Title

Peanut Consumption on Cognitive, Weight, and Inflammation

Who Can Participate

Age: 10Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Young adolescents aged between 10 and 12 years
  • Boys and girls attending regular primary schools in Barcelona
  • Voluntary participation with informed consent from parents or guardians
  • Ability to understand Spanish or Catalan
Not Eligible

You will not qualify if you...

  • History of allergy or intolerance to peanuts
  • Any medical condition or dietary restriction affecting peanut consumption
  • Use of antibiotics in the month prior to the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 2 weeks

Participants follow a peanut-free diet for two weeks before starting the intervention.

1 visit (in-person)

Treatment

Duration - 6 months

Participants consume 25 g of whole skin roasted peanuts daily as a snack incorporated into their diet, alongside a multidimensional educational intervention promoting healthy dietary habits, exercise, sleep, and emotional knowledge.

Regular visits for assessments and peanut delivery every two months

Follow-up

Duration - At 6 months (end of study)

Participants are assessed at the end of the intervention to evaluate changes in cognitive performance, weight management, inflammation, and other health outcomes.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

IDIBAPS

Barcelona, Barcelona, Spain, 08036

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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