Peanut Consumption on Cognitive, Weight, and Inflammation

NCT06127511 | Recruiting

• 1 other identifier: PEANUTY
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Performance; Inflammation; Weight Change, Body; Adolescents

Keywords

peanut; cognitive; inflammation; weight; adolescent; obesity; gut microbiota; healthy dietary; physical activity; sleeping; behaviour habits; Mediterranean diet

Outcome Measures

Primary Outcomes (10)

• 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.

  Baseline and after 6 months

• 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.

  Baseline and after 6 months

• 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.

  Baseline and after 6 months

• 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.

  Baseline and after 6 months

• Changes in attention and inductive reasoning in healthy young adolescents after a daily intake of peanuts.

  To measure in attention and inductive reasoning, the Raven-2 test will be used.

  Baseline and after 6 months

• Changes in Social cognition (emotion recognition and theory of mind) in healthy young adolescents after a daily intake of peanuts.

  To measure Social cognition (emotion recognition and theory of mind), the NEPSY-II subtest will be used.

  Baseline and after 6 months

• Changes in pro- and anti-inflammatory biomarkers after a daily intake of peanuts in healthy young adolescents.

  Cytokines (pg/mL), Monocyte chemoattractant protein-1 (MCP-1) (pg/mL), interleukin (IL)-6 and 10 (pg/mL), (mg/dL) will be assayed by immunoenzymatic methods.

  Baseline and after 6 months

• Changes in vascular biomarkers after a daily intake of peanuts in healthy young adolescents.

  sVCAM-1 and sICAM-1 (ug/mL) will be assayed by immunoenzymatic methods.

  Baseline and after 6 months

• Changes in adiposity molecules after a daily intake of peanuts in healthy young adolescents

  Adiponectin and adipsin (ug/mL), leptin (pg/mL), ghrelin (pg/mL), visfatin (pg/dL), resistin (pg/mL), insulin (pg/mL), glucagon (pg/dL), peptid C (pg/mL) and, PAI-1 (pg/mL) will be assayed by immunoenzymatic methods.

  Baseline and after 6 months

• Changes in body mass index after a daily intake of peanuts in healthy young adolescents

  Body mass index (kg/m\^2) are calculated after measure weight (kg) and height (meter).

  Baseline, 3 and after 6 months

Secondary Outcomes (13)

• Changes in waist circumference after a daily intake of peanuts in healthy young adolescents

  Baseline, 3 and after 6 months

• Changes in blood pressure after a daily intake of peanuts in healthy young adolescents

  Baseline, 3 and after 6 months

• Changes in heart rate after a daily intake of peanuts in healthy young adolescents

  Baseline, 3 and after 6 months

• Changes in lipidic profile after a daily intake of peanuts in healthy young adolescents

  Baseline and after 6 months

• Changes in blood glucose after a daily intake of peanuts in healthy young adolescents

  Baseline and after 6 months

Study Arms (2)

Peanuty group

EXPERIMENTAL

Families allocated in the intervention group will receive the whole skin roasted peanuts packed in daily doses (25 g per day, 750 g per month), starting the day that we will visit the participants for the first time. They will consume 25 g of whole skin roasted peanuts as a daily snack to be incorporated into their diet for six months.

Other: Food (peanut)

Control group

NO INTERVENTION

Usual care

Interventions

Food (peanut) OTHER

After the recruitment, the participants will follow a peanut-free diet for two weeks.

Peanuty group

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Eligible participants will be young adolescents, boys and girls, aged between 10 and 12 years who attend regular primary schools in Barcelona. The schools will assist with the participant recruitment through the classes and after that, a total of one-hundred students will be randomly included in each group. In all cases, participation will be voluntary and informed consent will be obtained prior to the study.

Sponsors & Collaborators

• University of Barcelona: lead
• Gasol Foundation: collaborator
• Universitat Oberta de Catalunya: collaborator
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator

Study Sites (1)

IDIBAPS

Barcelona, Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Inflammation; Body Weight Changes; Body Weight; Obesity; Motor Activity

Interventions

Food

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

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: Professor

Model Details: A multi-school, two-arm parallel cluster-randomized controlled trial

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 13, 2023
• Study Start: January 29, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)