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Omega-3 Supplementation to Both Parent and Adolescent

NCT05893550 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2023-06-08

No results posted yet for this study

Summary

The overarching, long-term goals are to develop a non-invasive biological approach to prevention of youth aggression, and ultimately adult violence.

The specific aims of this 2 x 2 randomized, double-blind, stratified, placebo-controlled trial of omega-3 supplementation to adolescents and caregivers are: (1) to investigate whether a nutritional intervention to adolescents and their parents can reduce externalizing behavior problems; (2) to examine the impact of a dual nutritional intervention to both parents and adolescents on adolescent externalizing behavior problems; (3) to identify mechanisms of action by which omega-3 supplementation impacts externalizing behavior in adolescents. It is expected that omega-3 supplementation will reduce adolescent behavior problems, and that dual supplementation to both the caregiver and adolescent will result in exponential improvements in adolescent behavior. A secondary prediction is that improvements in neurocognitive functioning will partially account for any behavioral improvements observed. Effects on scholastic ability are also explored.

Conditions

  • Behavior Problems

Interventions

DIETARY_SUPPLEMENT

Smartfish Omega

Fruit juice drink containing Omega-3: the experimental condition

DIETARY_SUPPLEMENT

Smartfish Fruit Juice Only

this is a fruit juice drink with no omega-3 added. it is the placebo condition

Sponsors & Collaborators

Principal Investigators

  • Adrian Raine, D.Phil. · University of Pennsylvania

  • Tashneem Mahoomed, BSc · Joint Child Health Project

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Mauritius

Study Locations

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Entities

Companies

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 NCT05893550 on ClinicalTrials.gov