A Pilot Study: Parent Perceptions of Behavior Change in Their Child With Autism Spectrum Disorder Following High Antioxidant Cacao Consumption

Abstract

Background

Autism spectrum disorder (ASD) is a heterogeneous neurocognitive disorder with primary symptomology related to maladaptive behaviors and communication deficits. Children with ASD tend to have higher free radicals than antioxidants compared with their matched controls. This disequilibrium of oxidative stress has been associated with the pathogenesis of this neurocognitive disorder. The aim of this pilot feasibility study was to examine the effect of high antioxidant cacao consumption on behavior in children with ASD.

Methods

This was a 4-wk repeated measures experimental pilot study of high antioxidant cacao and children with ASD. Participants consumed 8 squares (or 16 g) per day of the dark chocolate that had a concentration of 70% cacao and 30% organic cane sugar (total antioxidant activity was 8320 μmoles TE/100 g). The 2 main behavioral measures, Aberrant Behavior Checklist, 2nd ed (ABC-2) and the Autism Spectrum Rating Scale (ASRS), were completed by the child’s parent at baseline, end of week 2, and end of week 4.

Results

Seventeen participants were recruited for this study. Follow-up data were available for 16 participants (12 males, 4 females, aged 4 to 17 y). Significant improvements were noted on the ABC-2 subscales of irritability (P = .03, η²= 0.25), social withdrawal (P = .01, η²= 0.29), stereotypic behavior (P = .05, η² = 0.13), hyperactivity/noncompliance (P = .04, η² = 0.20), and inappropriate speech (P = .05, η² = 0.16). Significant improvements were noted on the ASRS subscales of social/communication (P = .04, η² = 0.25), unusual behaviors (P = .003, η²= 0.20), self-regulation (P = .02, η²= 0.32), and total scores (P < .001, η²= 0.54).

Conclusion

Results from this study support previous literature on antioxidant intake as an adjunct therapy to improve behaviors of children with ASD. More robust randomized controlled trials are now necessary to validate and elaborate on these findings.

Introduction

Autism Spectrum Disorder

Autism spectrum disorder (ASD) is a life-long neurodevelopmental disorder characterized by core deficits in communication skills, maladaptive behaviors, and self-regulation impairments related to atypical responses to sensory stimuli in the environment.¹ The prevalence of ASD in the United States is newly reported at 1 in 59 with it being 4.5 times more common in males than in females.² According to the World Health Organization,³ worldwide, 1 in 160 are identified as having ASD. The etiology of ASD remains unknown; however, genetic, environmental, immunological, and oxidative stress factors are linked to its pathogenesis.^4,5 In addition, perinatal and neonatal risk factors, such as, “abnormal fetal presentation, umbilical-cord complications, fetal distress, birth injury or trauma, multiple birth, maternal hemorrhage, summer birth, low birth weight, small for gestational age,” among others, have been identified as part of the association with ASD.⁶ The heterogeneity of ASD lends itself to the need for a variety of interventions, both traditional and nontraditional, because no single therapy works across the spectrum.

Conventional Therapies

Occupational therapists, speech therapists, and behavioral therapists are the most common professionals who work with children with ASD. Occupational therapists address self-regulation as it relates to sensory dysfunction in response to environmental stimuli, transitions between environments, and for task completion in home and school environments.⁷ Speech and language pathologists work on social interaction, communication skills, alternative communication techniques, among other speech-related impediments to enhance communication.⁸ Behavioral therapists work with children with ASD on aberrant behaviors, language skills, daily living skills, and social functioning. Applied behavioral analysis (ABA) uses rote discrete trials in a 1-on-1 setting and is an intensive approach that is recommended up to 40 hours per week.^9,10 All 3 of these intervention approaches are used in parallel to address children with ASD performance skills and behavior in both educational and home environments.

Currently, there are only 2 Food and Drug Administration-approved drugs for ASD: risperidone and Abilify.¹¹ Risperidone is a second-generation antipsychotic prescribed for maladaptive behaviors and self-injurious behaviors, whereas Abilify is a psychotropic drug that treats mood and irritability.¹¹ Adverse effects include weight gain, dizziness, drooling, fatigue, vomiting, nasopharyngitis, fever, insomnia, and upper respiratory infections.^12,13 Thus, there is both a place and need for complementary and alternative therapies in addressing the behavioral symptomology of ASD that impedes quality of life without some of the adverse effects of pharmacological agents.

When the aforementioned therapies and pharmaceutical agents are considered, the cost of ASD becomes colossal. A recent study reported that the cost of ASD in the United States, across one’s lifetime, is $1.4 million and $2.4 million, respectively, if they also have an intellectual disability.¹⁴ However, as with any disability or disorder, the cost is infinite because there are also psychological and stress costs that cannot be quantified for the individuals themselves or families caring for them. Lifestyle-oriented approaches may, then, be necessary not only to potentially offset costs and side effects but to improve quality of life in a long-term sustainable fashion.

Oxidative Stress and ASD

Even though ASD’s etiology is multifactorial and somewhat elusive, research suggests there may be neuron irregularity, between those with and without ASD, that is linked to the classic behavioral and social symptoms.¹⁵ Oxidative stress, an imbalance between antioxidants and free radicals, is of significance to this study and has been linked to the pathogenesis of ASD. Damodaran and Arumugam¹⁶ found a significant increase in oxidative stress markers in children with ASD compared with matched controls and the severity of maladaptive behaviors were positively correlated with free radicals, whereas antioxidants were negatively correlated with autistic behaviors.^16,17 In addition, elevated blood samples of glutathione, glutathione peroxidase, methionine, oxidized glutathione, and cysteine have also been found in children with ASD.¹⁷ These studies, although limited in number, suggest that the excess of free radicals may be linked to adverse behavioral outcomes.

Ming et al¹⁸ suggest that children with ASD tend to have greater markers of oxidative stress compared with age-matched controls or siblings without autism. Oxidative stress may be related to mitochondrial impairment, environmental factors, metabolic issues, and genetic predisposition.¹⁸ Inflammation, damage to cellular membranes, autoimmunity, methylation damage, cell death, and neurological impairments are all resultant of free radical damage.¹⁷ Oxidative stress can be identified through markers of antioxidant enzymes, lipid peroxidation, and protein oxidation, all of which are higher in children with autism compared with their matched controls.^5,18 In summary, the aforementioned studies support emerging evidence on the physiological differences in oxidative stress between children with ASD and those without, creating detrimental biological and behavioral outcomes.

Our bodies have an innate mechanism to endogenously produce antioxidants to counter the deleterious effects of free radicals caused by oxidative stress.^19,20 However, when these mechanisms are out of balance, we may need to consider nutritional options to supplement these deficits. Antioxidants benefit us physiologically by maintaining cellular integrity, combating free radicals, and improving vascular function while also offering neuroprotection by accumulating in the hippocampus and cortex.^21,22 As a result, antioxidants may be beneficial and necessary to provide homeostasis to oxidative stress imbalance, as seen in ASD.

To date, a few important studies examined the effects of antioxidant intervention relative to behavior change in the ASD population. Dolske et al²³ appear to be the first researchers to examine antioxidant therapy, in the form of vitamin C, providing 8 grams per 70 kg of body weight per day in 500 mg tablets for 30 weeks and found a reduction in autistic symptom severity. In addition, randomized controlled trials using N-acetylcysteine (NAC), an antioxidant prodrug, intervention found significant improvements in the irritability and hyperactivity/noncompliance subscales on the Aberrant Behavior Checklist (ABC).^24,25,26

Cacao is a natural and potent antioxidant. For the purposes of this paper, cacao and cocoa are used interchangeably. Flavonoids and flavanols, subclasses of antioxidants found in cacao²⁷ have been correlated with improved cognitive processing, alertness, and processing speed. Cocoa’s physiological and neurological benefits are vast and include improved cardiovascular activity, insulin resistance, blood pressure, lipid peroxidation, enhanced gamma frequency, and increased cerebral blood flow.^{21,27,28,29,30} In addition, cocoa protects neurons from apoptosis, promotes angiogenesis, and thus leads to more optimal brain functioning, which enhances delivery and receipt of oxygen and nutrient supply.³¹ The aforementioned studies summarize the inherent value in cacao as a natural functional food for the mind and the body, which may be of significant value to neurocognitive disorders, such as ASD.

Thus, the purpose of this study was to examine changes in ASD children’s behavior following dark chocolate consumption, in the course of a 4-week period. Behavioral changes were assessed by each child’s parent using 2 behavior scales: ABC, 2nd edition, (ABC-2) and Autism Spectrum Rating Scale (ASRS).^32,33

Methods

Study design

This was a 4-week repeated measures experimental pilot feasibility study and clinical trial of children with ASD who consumed high antioxidant cacao, or dark chocolate. The study was conducted in Southern California between September 2017 and March 2018. Recruitment of participants through snowball sampling techniques was initiated following study approval. This study was approved by the institutional review board at Loma Linda University (Loma Linda, CA, USA) and was registered in the National Institutes of Health online database at clinicaltrials.gov (NCT No. 03195465). An Investigational New Drug application was submitted to the FDA; however, it was not required for the study.

Participants

Participants were children with a diagnosis of ASD, between the ages of 4 and 17 years, and their parents. Seventeen children and their parents were recruited. One participant dropped, leaving a total sample of 16 with follow-up data. For subjects’ characteristics, refer to Table 1. To be eligible for the study, participants had to have a diagnosis of ASD, be between the ages of 4 and 18 years, and like eating dark chocolate. A taste test was offered to the child at baseline to ensure he/she would be willing to eat it daily for 4 weeks. Participants with food allergies, caffeine hypersensitivity, theobromine hypersensitivity, a history of seizures or epilepsy, a developmental age less than 24 months, diabetes, and those who were currently enrolled in another study were excluded from this study.

Table 1.

Participant Characteristics (N = 16)

	n	%
Age (Mean ± SD)	11.1 ± 3.6
Male	12	75.0
Grade
K	2	12.5
1	1	6.3
2	1	6.3
4	1	6.3
5	2	12.5
6	3	18.8
7	2	12.5
9	1	6.3
10	2	12.5
12	1	6.3
Verbal ability
Nonverbal	3	18.8
Limited verbal	2	12.5
Verbal	11	68.8
Ethnicity
White	5	31.3
Hispanic or Latino	4	25.0
Black or African American	1	6.3
Asian	1	6.3
Native Hawaiian	1	6.3
Mixed ethnicity	4	25.0
Diagnosed by
Pediatrician	4	25.0
Neurologist	5	31.3
Inland regional center	5	31.3
Psychologist	2	12.5
Employment
Full time	7	43.8
Part time	3	18.8
Out of work and looking	1	6.3
Home maker	4	25.0
Out of work not looking	1	6.3
Education
Some high schoool	1	6.3
Some college	2	12.5
Associate’s degree	3	18.8
Bachelor’s degree	6	37.5
Master’s degree	4	25.0
Income
$20 000-$34 999	2	12.5
$35 000-$49 999	2	12.5
$50 000-$74 999	2	12.5
$75 000-$99 999	4	25.0
$100 000-$149 999	5	31.3
$150 000 or more	1	6.3
Marital status
Single	1	6.3
Married	13	81.3
Divorced	1	6.3
Separated	1	6.3
Custodya
Mother	2	12.5
Shared	1	6.3

^aPercentages do not add to 100% because parents are married.

Abbreviation: SD, standard deviation.

Procedures and Intervention

The cacao utilized in this study was analyzed for total antioxidant activity at Medallion Laboratories in Minnesota. Medallion Labs are considered to be a premiere and accredited nutraceutical lab that use scientifically sound analyses on food, dietary supplements, and pharmaceutical agents. The standardized unit of analysis for total antioxidant activity is measured in μmoles trolox equivalent (TE)/100 g.³⁴ The antioxidant activity of the cacao used was 52 000 μmoles TE/100 g. The dark chocolate used in this study consisted of 2 ingredients, 70% cacao and 30% organic cane sugar, both of which contain antioxidants. Participants in the study consumed 8 squares of the dark chocolate, or 16 g per day totaling 8320 μmoles TE/100 g per day. Participants consumed 4 squares of the cacao twice daily with the first dose in the morning and the second dose in the afternoon, or early evening. All participants were asked to be consistent at both times of day for the duration of the study and logs were kept and collected each week to assess compliance. The cacao was wrapped in parchment paper and foil, then sealed in Ziploc bags to protect it from light and air to prevent oxidation to maintain the cacao’s antioxidant integrity.

Measures

The primary outcome measures were the ABC-2 and the ASRS. Both scales have been validated and used to assess behavioral outcomes in children with ASD.^32,33,34

The ABC-2 measures behaviors in populations with developmental delays and is traditionally administered to children ages 5 years and older; however, permissions were obtained from the developer to administer to ages 4 years and older.³² The ABC-2 scale consists of 5 subscales including irritability, social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech. It is composed of 58 questions that assess severity of the problem with scores ranging from 0 to 3; 0 = no problem, 1 = the behavior is not a problem but slight in degree, 2 = the problem is moderately serious, and 3 = the problem is severe in degree.^32,35 Subscale sums were calculated and larger subscale totals indicated more severe behaviors in that category.

The ASRS consists of 3 scales which include social/communication, unusual behaviors, and self-regulation for 6- to 18-year-olds and social/communication and unusual behaviors for 2- to 5-year-olds. It is composed of 71 questions that assess frequency of behaviors, with scores ranging from 0 to four; 0 = behavior never happens, 1 = rarely happens, 2 = occasionally happens, 3 = frequently happens, and 4 = happens very frequently. In other words, the higher the score, the more severe the behaviors for each scale. Scores from each scale were calculated using t scores in accordance with the standard scoring technique.³³ Parents filled out the ABC-2 and ASRS at baseline, end of week 2, and end of week 4.

Statistical Analyses

A sample size of 15 subjects was estimated using a medium effect size of 0.70, a power of 0.80, and a level of significance set at .05. Data analysis was performed using IBM SPSS for Windows, version 25.0 (IBM, Armonk, NY, USA). Data were summarized using mean ± standard deviation for quantitative variables and frequency (%) for categorical variables. The normality of the outcome variables was examined using Shapiro-Wilk test. Friedman’s test was conducted to determine overall change over time. Wilcoxon signed-rank test was used to compare changes between different time points (baseline vs 2 wk; baseline vs 4 wk; 2 wk vs 4 wk) in ABC-2 and ASRS scores. Results were considered significant at P ≤ .05.

Results

Participant characteristics are reported in Table 1. Sixteen children with ASD with a mean age of 11.1 ± 3.6 years participated in the study. Seventy-five percent were males (n= 12), 31% were White (n = 5), and 25% were Hispanic or Latino (n = 4). A majority of participants were enrolled in an individualized education program (n = 15, 93.8%) and were verbal (n = 11, 68.8%). Forty-four percent of parents worked full time (n = 7), 62% had a college degree (n = 10), 62% reported an income of $75 000 or higher (n = 9), and 81% were married (n = 13) (Table 1).

Children’s medical history and type of therapy are displayed in Table 2. Twenty-five percent of participants had ADHD (n = 4) and were taking medication for attention-related issues (n = 4). Approximately 56% sleep, on average, 7 or more hours per night (n = 9). The majority of participants either previously received or were concurrently receiving speech therapy, occupational therapy, and ABA (Table 2).

Table 2.

Child’s Medical History and Type of Therapy (N = 16)

	n	%
Headaches	2	12.5
ADHD	4	25.0
Anxiety/Depression	3	18.8
Sleeping Disorder	1	6.3
Hours of sleep per night
4-6 h	2	12.5
7-8 h	9	56.2
9 h or more	5	31.3
Medications
Attention	4	25.0
Anxiety	3	18.8
Mood disorder	2	12.5
Headache	1	6.3
Behavior	3	18.8
Type of Therapy
Individual psychotherapy	1	6.3
Group psychotherapy	2	12.5
Family therapy	1	6.3
Speech therapy	15	93.7
Occupational therapy	14	87.5
Applied behavior analysis	11	68.8
Physical therapy	4	25.0
Early intervention	11	68.8

Abbreviation: ADHD, attention-deficit/hyperactivity disorder.

Changes in ABC-2 and ASRS scores are reported in Table 3. Friedman’s test results showed there were significant improvements over time in the ABC-2 subscales of irritability (P = .03, η² = 0.25), social withdrawal (P = .01, η² = 0.29), stereotypic behavior (P = .05, η² = 0.13), and hyperactivity/noncompliance (P = .04, η² = 0.20). However, no significant difference was noted for inappropriate speech (P = .22, η² = 0.16). Friedman’s test also showed a significant improvement in all ASRS subscales including social/communication (P = .04, η² = 0.25), unusual behaviors (P = .003, η² = 0.20), self-regulation (P = .02, η² = 0.32), and total scores (P < .001, η² = 0.54) (Table 3).

Table 3.

Median (Min, Max) Scores for ABC-2 and ASRS Over Time

Scale	Subscale	Baseline	Week 2	Week 4	P Valuea (η2)
ABC-2	Irritability	13.0 (0, 35)	13.0 (0, 31)	7.0 (0, 34)	P = .03, η2 = 0.25
	Social withdrawal	13.0 (1, 34)	9.0 (0, 37)	7.5 (0, 34)	P = .01, η2 = 0.29
	Stereotypic behavior	3.5 (0, 15)	3.0 (1, 14)	1.0 (0, 16)	P = .05, η2 = 0.13
	Hyperactivity/noncompliance	15.0(4, 42)	12.0 (2, 39)	9.5 (0, 42)	P = .04, η2 = 0.20
	Inappropriate speech	3.0 (0, 9)	2.0 (0, 9)	1.5 (0, 10)	P = .22, η2 = 0.16
ASRS	Social/communication	70.0 (58, 85)	65.5 (52, 82)	68.0 (43, 85)	P = .04, η2 = 0.25
	Unusual behaviors	69.0 (45, 83)	66.0 (7, 74)	61.0 (43, 74)	P = .003, η2 = 0.20
	Self-regulation	65.0 (48, 76)	64.0 (47, 75)	60.0 (38, 77)	P = .02, η2 = 0.32
	Total of 3 subscales t score	72.0 (54, 83)	68.5 (50, 77)	62.0 (45, 79)	P <.001, η2 = 0.54

Note:

^aFriedman test.

Abbreviations: ABC-2, Aberrant Behavior Checklist, 2nd edition; ASRS, Autism Spectrum Rating Scale; η² = effect size.

Post hoc comparisons revealed that there was a significant difference in irritability between baseline and week 4 (P = .035) and between week 2 and week 4 (P = .014). For social withdrawal, a significant difference was found between baseline and week 2 (P = .03) and baseline and week 4 (P = .023). A significant difference was also found in stereotypic behavior between baseline and week 4 (P = .05) and between week 2 and week 4 (P = .04). Finally, there was a significant improvement in median hyperactivity/noncompliance scores between baseline and week 4 (P = .035). No significant difference was found in median scores for inappropriate speech over time (P = .22).

With regard to the ASRS scales, a significant difference was found in social/communication between baseline and week 2 (P = .009) and between baseline and week 4 (P = .026). A significant difference was found in unusual behaviors between baseline and week 2 (P = .022) and baseline and week 4 (P = .001). There was a significant difference in self-regulation between baseline and week 2 (P =. 018) and baseline and week 4 (P = .012). Overall, there was a significant difference in median total scores on the ASRS between baseline and week 2 (P = .002), baseline and week 4 (P = .002), and between week 2 and week 4 (P = .02) (Table 3).

Discussion

In this pilot study, a repeated measures experimental clinical trial was conducted to examine the effects of high antioxidant cacao consumption on behaviors in children with ASD. Overall, participant characteristics revealed that parents were well educated, and of an above average socioeconomic status, and most parents were married. A previous study indicated that parents of children with ASD, who are more educated and affluent, tend to try alternative therapies more than others, which is in alignment with the demographics of our sample.³⁶

Based on parental report, the dark chocolate was well tolerated and no allergic reactions were reported in the course of the intervention. The results of this study indicated that parents perceived a significant improvement in their child with ASD behavior in the ASRS scales of (1) social/communication, (2) unusual behaviors, and (3) self-regulation, suggesting that the frequency of maladaptive behaviors in these categories were reduced. Significant improvements were also noted on the ABC-2 subscales of (1) irritability, (2) social withdrawal, (3) stereotypic behavior, and (4) hyperactivity/noncompliance suggesting that the severity of these behaviors was reduced in the course of the intervention. Overall, median scores decreased, indicating that participants were less irritable, socially withdrawn, and they had reduced stereotypic behaviors. In addition, participants improved in their social/communication skills and self-regulation and had less unusual behaviors. The results of this study are consistent with the findings from the NAC and ASD studies that found improvements in hyperactivity and irritability ABC-2 subscales.^24,25,26 Furthermore, the present study found improvements in social withdrawal and stereotypic behavior, which the aforementioned studies did not find. Neither the NAC studies nor the present study found statistical significance in inappropriate speech on the ABC-2. Based on these studies, there is promising benefit of antioxidant-based therapies in targeting common behavioral symptoms in ASD.^24,25,26

Although there is limited research on antioxidants, specifically cacao, and the population with autism, previous literature on adults suggests the neuroprotective benefits of cacao. In recent reviews, the benefits of the cocoa bean and its derivatives were associated with improved cerebrovascular function, permeation of the blood brain barrier via flavanols (epicatechin and catechin), working memory, attention, processing speed, and learning.^31,37 Furthermore, ingestion of cocoa flavanols in adults significantly improved cognitive scores, visual information processing, visual contrast sensitivity, and spatial memory.^38-40 These studies, however, did not report total antioxidant concentration nor was a consistent amount provided throughout the literature. The aforementioned studies acknowledge that the underlying mechanisms of cocoa on brain health are still under investigation; however, observed benefits may be related to effects on endothelial function and blood flow, which promote oxygen and nutrient delivery systemically. Although the research available on cocoa’s physiological and neurological benefit for adults is useful, there is still a gap in the literature on how cocoa can be used in the pediatric population, specifically those with neurocognitive disorders.

Our study had some limitations. First, we recognize the lack of control group limits the generalizability of these results. However, given the feasibility nature of this study we aimed to determine whether a randomized controlled trial was warranted by first assessing behavior through psychometric assessments. In addition, we were unsure what recruitment would be like, whether the children would take to this kind of dark chocolate compared with traditional more sweet and processed chocolate, and whether parents would be interested in participating and being compliant with the regimen. Second, our assessments, although validated and reliable, were self-report measures, which may include biases. However, previous research suggests the effects that ASD behaviors have on the parent, and so their observations of behavior change may be most accurate as they understand the intricacies of their child’s maladaptive behaviors.⁴¹ Behaviors associated with ASD not only affect the parent child dynamic but also dually stress both the parent and child individually.⁴¹ In addition, parents may be accurate raters because their stress has been correlated with the severity of their child’s behaviors, so if behaviors, are more or less severe, they would be directly impacted and thus able to report changes.⁴² Our results do support the notion that parents can appropriately assess both severity and frequency of maladaptive behaviors.

Third, nutritional intake was not monitored in the course of the study, which means dietary confounders could have affected results. In an attempt to control for dietary effects, we avoided enrolling participants near major holiday breaks, such as Christmas and Thanksgiving, where diet may change more drastically. Fourth, the study length may not have been enough to show more significant behavior change in the participants. Previous antioxidant studies used different study lengths ranging from 8 weeks, 10 weeks, 12 weeks, and up to 30 weeks compared with 4 weeks in the present study.^23-26 However, it should be noted that although the present study was shorter in length the results were comparable to the aforementioned studies in the irritability and hyperactivity subscales on the ABC-2. The results of this study demonstrated an overall improvement in 4 of 5 ABC-2 subscales and all 3 ASRS scales with the most significant changes being after 2 weeks of intervention. Without a control group, it is difficult to rule out the potential for a placebo effect. However, some of the nonsignificant findings between baseline and week 2 strengthens the interpretation of results by suggesting that the significant effects observed after 2 weeks may not simply be driven by parents’ belief but an actual intervention effect on behavior.

A major strength of the present study was the low attrition rate since only 1 participant withdrew from the study. Previous antioxidant and ASD studies did not mention total antioxidant activity of interventions used nor was amount of NAC based on anthropometric assessments of individual participants.^23-26 Thus, another strength of the present investigation is the analysis and report of total antioxidant activity of the cacao validating its use as an antioxidant intervention. It should be noted that because this was a pilot feasibility study, it seemed premature to include different intake concentrations of cacao for participants as previous literature on adults was inconsistent and limited. However, future studies may want to consider offering different concentrations based on anthropometric measurements as nutritional needs differ across the lifespan. All participants were receiving 1 or more traditional therapies targeting core symptoms; however, it would be unethical and unrealistic to include children with ASD who were not receiving any type of therapy.

Future studies are recommended to run the intervention for longer periods and measure changes throughout the study to determine when the effect occurs. Analysis of biomarkers including urine or serum blood samples will be imperative to determine any physiological changes in oxidative stress status. Comparing groups using different concentrations of cacao based on anthropometric assessments, such as weight, through randomized controlled trials will further validate whether observed changes are in fact due to the antioxidant intervention. Complementary and alternative medicine (CAM) needs to be researched to determine efficacious approaches in the ASD population with consideration of the child’s medical history and diet history before recommendations can be made.⁴³ Biologically based therapies, including nutraceuticals, are commonly employed by parents of children with disabilities because CAM interventions do not have the same adverse side effects as pharmaceutical interventions. Thus, nutrition interventions, more specifically antioxidant therapies, as used in this study, need to remain under investigation as a potential CAM for addressing and hopefully improving ASD behavioral symptoms.

Conclusion

To the authors’ knowledge, to date, this is the first pilot study associating consumption of a nutraceutical, high antioxidant cacao, to behavioral outcomes in the ASD population from a parent’s perspective. Results from this study add to the existing literature on the potential benefits of antioxidants on improving behavior in children with ASD. Further robust randomized controlled trials are needed to further validate these positive findings.

Biographies

Amy Sadek, PhD, MOT, OTR/L, BS, is a PhD candidate in rehabilitation sciences at Loma Linda University (LLU) in Loma Linda, California.

Lee S. Berk, DrPH, is the associate dean of research affairs and a full professor in the School of Allied Health Professions, Department of Allied Health Studies at LLU.

Karen Mainess, PhD, SLP, CCC, is an assistant professor in the School of Allied Health Professions, Department of Communication Sciences and Disorders at LLU.

Noha S. Daher, DrPH, is a full professor in the School of Allied Health Professions, Department of Allied Health Studies at LLU.