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

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ClinicalTrials.gov Identifier: NCT03195465
Recruitment Status : Active, not recruiting
First Posted : June 22, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

Tracking Information
First Submitted Date  ICMJE June 20, 2017
First Posted Date  ICMJE June 22, 2017
Last Update Posted Date March 27, 2018
Actual Study Start Date  ICMJE November 14, 2017
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
  • Aberrant Behavior Checklist [ Time Frame: Change between baseline and end of week 2. ]
    This is a valid and reliable tool that is made up of 58 questions comprised of 5 main content areas: Irritiability, agitation, crying; Lethargy and Social Withdrawal; Stereotypic Behavior, Hyperactivity Non Compliance, and Inappropriate Speech.
  • Aberrant Behavior Checklist [ Time Frame: Change between end of week 2 and end of week 4. ]
    This is a valid and reliable tool that is made up of 58 questions comprised of 5 main content areas: Irritiability, agitation, crying; Lethargy and Social Withdrawal; Stereotypic Behavior, Hyperactivity Non Compliance, and Inappropriate Speech.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03195465 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
  • Autism Spectrum Rating Scale [ Time Frame: Change between baseline and end of week 2. ]
    A valid and reliable tool with 71 items and each item is ranked with scores from 0 to 4 with 0 meaning the behavior never happens and 4 means it happens very frequently. This rating scale asks questions related to play skills, social interaction skills, communication skills, rigid behaviors, and understanding of humor.
  • Autism Spectrum Rating Scale [ Time Frame: Change between baseline and end of week 4. ]
    A valid and reliable tool with 71 items and each item is ranked with scores from 0 to 4 with 0 meaning the behavior never happens and 4 means it happens very frequently. This rating scale asks questions related to play skills, social interaction skills, communication skills, rigid behaviors, and understanding of humor.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 20, 2017)
Parental Stress Index [ Time Frame: Change between baseline and end of week 4 ]
Designed to evaluate the magnitude of stress in the parent-child system, with 120 questions that focus on three major domains of stress: child characteristics, parent characteristics, and situational/demographic life stress.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of High Antioxidant Cacao on Behaviors in Children With Autism Spectrum Disorder
Official Title  ICMJE The Effect of High Antioxidant Cacao on Behaviors in Children With Autism Spectrum Disorder
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.
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 Special Education 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Dietary Supplement: Dark Chocolate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 20, 2017)
23
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03195465
Other Study ID Numbers  ICMJE 5170206
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Loma Linda University
Study Sponsor  ICMJE Loma Linda University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lee Berk, DrPH Loma Linda University
PRS Account Loma Linda University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP