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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195465
Recruitment Status : Terminated (PI left institution. Efforts made to contact PI unsuccessful. No study data available.)
First Posted : June 22, 2017
Results First Posted : May 13, 2021
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Dietary Supplement: Dark Chocolate Not Applicable

Detailed Description:

Subjects will include both males and females with an age range between 5 and 18 years. Study will include subjects from any race or ethnicity that meet eligibility criteria. Inclusion criteria: children with a diagnosis of Autism Spectrum Disorder, are between the ages of 5 and 18, and like 70% dark chocolate. Exclusion criteria: Food allergies, Caffeine hypersensitivity, Theobromine hypersensitivity, History of seizures or epilepsy, Developmental age < 24 months, and Diabetics. The target study population is school aged children with a diagnosis of Autism Spectrum Disorder. Participants will be recruited using snowballing and judgmental sampling via word-of-mouth, flyers, emails, and social media with a $50.00 gift card offered for participants who complete the study in full and $15.00 gift card for teachers who complete study in full. Flyers will be distributed throughout the Southern California area due to proximity, however, participants may come from any region if satisfying inclusion criteria and time commitment. Flyers will be placed in, but not limited to, common public places such as local community centers, pediatric therapy clinics, pediatricians' offices, churches, schools, and more. The principal student researcher or appropriate PhD committee personnel will acquire email addresses of potential participants. Specific social media outlets will include postings on, but not limited to, Facebook, Instagram, and Twitter. The name of the principal investigator and contact information of the student researcher will be available on the flyer with an invitation to contact researchers with any questions about the study. Families of those children with a diagnosis of Autism Spectrum Disorder will be offered a flyer to determine if they are interested in participating in the study. The informed consent process will be facilitated by the student researcher with the parents of the child with a diagnosis of Autism Spectrum Disorder. The informed consent process will take place at a location of convenience for parents who will be provided fifteen minutes for decision making and discussion. Due to the subjects' impaired decision making capacity, the parents will provide consent on their behalf. HIPPA compliance forms will be included with informed consent process. Privacy of medical and research records will be secured in a locked cabinet in a locked office.Procedures are listed as follows:

  1. Informed Consent and HIPPA documents.
  2. Subject will also be offered a taste testing of the chocolate bar to be used in the study as liking the 70% dark chocolate is part of inclusion criteria.
  3. After consent is provided, parent will fill out the Youth & Adolescent Food Frequency Questionnaire based on their child's typical dietary habits, an Autism Spectrum Rating Scale, an Aberrant Behavior Checklist, and the Parental Stress Index Questionnaire.
  4. Student researcher will prepare doses (4 squares per dose or 8 grams) of the dark chocolate for each child in one week increments at a time. The dark chocolate will be wrapped in foil to protect against light and kept in a sealed Ziploc bag to prevent against oxidation in order to maintain the cacao's integrity.
  5. Student researcher will meet with each parent/family once per week to collect any questionnaires and to deliver the dark chocolate doses for the subsequent weeks.
  6. Student researcher will meet with teachers at baseline, end of week two, and end of week four to collect all questionnaires.
  7. Subject will consume 4 squares of the dark chocolate twice daily between the hours of 6 a.m. and 6 p.m.
  8. Student researcher will contact parents and teachers weekly via phone/email to follow up on administration of the chocolate.
  9. Parent and primary school teacher will fill out the Autism Spectrum Rating Scale and the Aberrant Behavior Checklist at the end of week two and at the end of week four.
  10. Parent will fill out the Parental Stress Index Questionnaire at the end of week four.

Research analysis plan will include non-parametric statistics. For the pre-test and post-test analysis of the Parental Stress Index scale Friedman's test will be used. For all other repeated measures such as the Aberrant Behavior Checklist and the Autism Spectrum Rating Scale the Wilcoxon Signed Rank Test will be used.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of High Antioxidant Cacao on Behaviors in Children With Autism Spectrum Disorder
Actual Study Start Date : November 14, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cacao group
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Aberrant Behavior Checklist 2nd Edition [ Time Frame: Change in subscale scores over the four weeks. ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Food allergies, Caffeine hypersensitivity, Theobromine hypersensitivity, History of seizures or epilepsy, Developmental age < 24 months, and Diabetics.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195465


Locations
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United States, California
Loma Linda University Health
Loma Linda, California, United States, 92505
Sponsors and Collaborators
Loma Linda University
Investigators
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Study Chair: Lee Berk, DrPH Loma Linda University
  Study Documents (Full-Text)

Documents provided by Loma Linda University:
Study Protocol and Statistical Analysis Plan  [PDF] August 2, 2017

More Information
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Publications:

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Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT03195465    
Other Study ID Numbers: 5170206
First Posted: June 22, 2017    Key Record Dates
Results First Posted: May 13, 2021
Last Update Posted: June 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders