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

NCT03195465 | Terminated Results

• 1 other identifier: 5170206
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Aberrant Behavior Checklist 2nd Edition

  This is a valid and reliable tool that is made up of 58 questions comprised of 5 main content areas: Irritability; Social Withdrawal; Stereotypic Behavior, Hyperactivity Non Compliance, and Inappropriate Speech.

  Change in subscale scores over the four weeks.

Study Arms (1)

Cacao group

EXPERIMENTAL

1 group of subjects will all receive the high antioxidant cacao bars. 4 squares of the dark chocolate will be administered twice daily between the hours of 6 a.m. and 6 p.m.

Dietary Supplement: Dark Chocolate

Interventions

Dark Chocolate DIETARY_SUPPLEMENT

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.

Cacao group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with a diagnosis of Autism Spectrum Disorder, are between the ages of 4 and 18, and like 70% dark chocolate.

You may not qualify if:

• Food allergies, Caffeine hypersensitivity, Theobromine hypersensitivity, History of seizures or epilepsy, Developmental age \< 24 months, and Diabetics.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92505, United States

Location

Related Publications (3)

• Damodaran LP, Arumugam G. Urinary oxidative stress markers in children with autism. Redox Rep. 2011;16(5):216-22. doi: 10.1179/1351000211Y.0000000012.

  PMID: 22005342 BACKGROUND

• Hardan AY, Fung LK, Libove RA, Obukhanych TV, Nair S, Herzenberg LA, Frazier TW, Tirouvanziam R. A randomized controlled pilot trial of oral N-acetylcysteine in children with autism. Biol Psychiatry. 2012 Jun 1;71(11):956-61. doi: 10.1016/j.biopsych.2012.01.014. Epub 2012 Feb 18.

  PMID: 22342106 BACKGROUND

• Scholey AB, French SJ, Morris PJ, Kennedy DO, Milne AL, Haskell CF. Consumption of cocoa flavanols results in acute improvements in mood and cognitive performance during sustained mental effort. J Psychopharmacol. 2010 Oct;24(10):1505-14. doi: 10.1177/0269881109106923. Epub 2009 Nov 26.

  PMID: 19942640 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Amy Sadek, PhD Rehabilitation Science
• Organization: Loma Linda University School of Allied Health Professions

asadek@llu.edu

951-212-2104

Study Officials

• Lee Berk, DrPH

  Loma Linda University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: November 14, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: June 2, 2021
• Results First Posted: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)