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Walnuts, Long-Chain Polyunsaturated Fatty Acids and Adolescent Brain Development

NCT02590848 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2020-06-09

No results posted yet for this study

Summary

Background: Adolescence is an important period for brain development as a result of increased synaptic plasticity. Omega-3 polyunsaturated fatty acids (n-3 PUFAs) are essential nutrients for brain development and protection against oxidative stress. Walnuts have the highest n-3 PUFA concentrations of all edible plants.

Objective: The investigators hypothesize that walnut intake will increase n-3 PUFA availability in the body to a level that enhances the development of the brain during adolescence. The technicians will conduct a long-term (6 months) population-based randomized controlled trial in teenagers (n=400 in each arm), and determine the effectiveness of the intervention (30 g of walnut kernels per day, \~1.5g of n-3 PUFA) in enhancing brain development.

Methods: Fieldwork team will contact teenagers and families in collaboration with 20 high schools. Families will receive a basic guide on following a healthy diet in order to ensure implementation and adherence. Brain development outcomes will be measured at baseline and after the intervention. The use of computerized neuropsychological tests will provide the precision required to detect even subtle changes in brain development resulting from the nutritional intervention. Behavioral (socio-emotional) development will be assessed in order to cover a wider picture of brain development. Blood samples will be collected to measure n-3 PUFA levels before and after the intervention in a randomized subsample from both groups (control/ intervention). Linear regression models adjusted for baseline neuropsychological scores will be used to analyze the intervention effect.

Implications: The outcomes of this Project are expected to be a greater understanding of the role of n-3 PUFA intake (walnut) in brain development. A major goal in public health research is to develop cost-effective health recommendations to teenagers.

Conditions

  • Vitamin/Nutritional Deficiency
  • Neurobehavioral Manifestations

Interventions

DIETARY_SUPPLEMENT

Walnut intake

Nutritional intervention: 30g walnut kernels per day

Sponsors & Collaborators

  • Carlos III Health Institute

    collaborator OTHER_GOV

  • Barcelona Institute for Global Health

    lead OTHER

Principal Investigators

  • Jordi Julvez Calvo, PhD · Fundació Centre de Recerca en Epidemiologia Ambiental, Barcelona, Spain

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-07-30
Completion
2019-06-05

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02590848 on ClinicalTrials.gov