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PI left institution. Efforts made to contact PI unsuccessful. No study data available.
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Berk, DrPH | Loma Linda University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Health | Loma Linda | California | 92505 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22005342 | Background | Damodaran LP, Arumugam G. Urinary oxidative stress markers in children with autism. Redox Rep. 2011;16(5):216-22. doi: 10.1179/1351000211Y.0000000012. | |
| 22342106 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
PI left institution without completing results. All efforts to contact PI for data have been unsuccessful. No data available to report.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | PI left institution without completing results. Multiple attempts made to contact PI without success. Not data available to submit. | Posted | Change in subscale scores over the four weeks. |
|
PI left institution without completing results. All efforts to contact PI for data have been unsuccessful. No time frame available to report.
PI left institution without completing results. All efforts to contact PI for data have been unsuccessful. No data available to report.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Sadek, PhD Rehabilitation Science | Loma Linda University School of Allied Health Professions | 951-212-2104 | asadek@llu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2017 | May 17, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 19942640 | 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. |
| years |
| Sex: Female, Male |
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| Race (NIH/OMB) |
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| Abberant Behavior Checklist | PI left institution. Efforts made to contact PI unsuccessful. No study data available. |
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| 0 |
| 0 |
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