The Effect of High Antioxidant Cacao on Behaviors in Children With Autism Spectrum Disorder

NCT03195465 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-06-02

Study results available
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Summary

The purpose of this study is to determine if routine consumption of high antioxidant cacao can have an effect on the behaviors of children with Autism Spectrum Disorder. This is proposed as children with Autism Spectrum Disorder have elevated oxidative stress markers, such as, free radicals making them highly vulnerable to oxidative damage. Thus, it is proposed that foods high in antioxidant activity can offer protection against oxidative stress and thus impact behaviors.

Conditions

Interventions

DIETARY_SUPPLEMENT

Dark Chocolate

Dark Chocolate bars with 70% cacao and 30% organic cane sugar where 4 squares of the dark chocolate will be administered twice daily between the hours of 6 a.m. and 6 p.m. daily for four weeks.

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Lee Berk, DrPH · Loma Linda University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2018-04-01
Completion
2018-04-01

Countries

  • United States

Study Locations

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Entities

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 NCT03195465 on ClinicalTrials.gov