Trial Outcomes & Findings for The Effect of High Antioxidant Cacao on Behaviors in Children With Autism Spectrum Disorder (NCT NCT03195465)
NCT ID: NCT03195465
Last Updated: 2021-06-02
Results Overview
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.
TERMINATED
NA
16 participants
Change in subscale scores over the four weeks.
2021-06-02
Participant Flow
Participant milestones
| Measure |
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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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of High Antioxidant Cacao on Behaviors in Children With Autism Spectrum Disorder
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Change in subscale scores over the four weeks.Population: PI left institution without completing results. Multiple attempts made to contact PI without success. Not data available to submit.
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.
Outcome measures
Outcome data not reported
Adverse Events
Cacao Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Amy Sadek, PhD Rehabilitation Science
Loma Linda University School of Allied Health Professions
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place