Dates as a Functional Food for Autism

NCT04261595 | Completed DMC

• 1 other identifier: 12060158
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Autism spectrum disorder (ASD) is a lifelong developmental disability that includes deficits in social communication and social interaction and restricted, repetitive patterns of behavior, interests, or activities. The current treatment approaches for the management of autism are expensive, showing unwanted adverse effects; alter the genetic and metabolic pathways. Many studies referred to the importance of probiotics, minerals and antioxidant supplementation in the treatment of accompanied eating and feeding problems. Meanwhile, there are still controversial results about the effectiveness of dietary interventions for ASD like the gluten-free/casein-free diet and the ketogenic diet. Dates have been documented in the Holy Quran and proved in modern scientific literature to act as potent antioxidants and as an anti-inflammatory, provide a suitable alternative therapy in various diseases cure. The medicinal therapeutic value of date fruits as nutritional probiotic and its implications in controlling autism through the anti-oxidant effect will be evaluated. Moreover, at which dose Dates fruit can exert its effect and whether this effect is sustained or not will be also evaluated. Besides, Dates' effect on cognitive, neurological parameters, eating behaviors, and gastrointestinal symptoms and anthropometric measures will be evaluated. A non-randomized clinical study on 120 diagnosed autistic children aged 3-12 years in Cairo will be conducted. Participants will be randomly assigned to one of three groups (each with 40 children) receiving one of three regimens; the first group will receive 3 Dates per day for 3 months and the second group will receive 5 Dates per day for 3 months and the third group will receive nothing. All groups will receive nutrition guidance, behavioral modification, and stimulation sessions. Stools and blood samples will be collected before the study, after 12 weeks of the intervention and then 12 weeks after completion of the intervention. Evaluating Dates' ability to decrease the oxidative stress will be done through comparing blood levels of three oxidative markers; Malondialdehyde (MDA), glutathione peroxidase (GPX1) and superoxide dismutase (SOD) in children with autism for the three proposed regimen. The impact of the Dates fruit consumption on the microbiota of the autistic children both the pathogenic bacteria and probiotics will be done through traditional stool analysis and Real-time PCR before and after interventions.

Conditions

Autistic Spectrum Disorder

Keywords

Dates; Autism; microbiota; antioxidant; anti- inflammatory

Outcome Measures

Primary Outcomes (3)

• Dates' ability to change the oxidative stress of ASD

  comparing blood levels of three oxidative markers; Malondialdehyde (MDA), glutathione peroxidase (GPX1) and superoxide dismutase (SOD) in children with autism for the three proposed regimen. Measuring the difference pre and three months after the intervention, before and six months after the intervention

  ifference from the initial (before the intervention) with that three and Six months after the initiation of the intervention

• change on the pathogenic microbiota of the autistic children as detected by traditional stool analysis through DNA extraction (quantitative PCR) of the fecal samples

  Through the quantitative PCR (qPCR) for the change in the presence and absence of the targeted bacterial subgroups (including Bifidobacterium, lactobacillus, Clostridium, Sutterella)

  ifference from the initial (before the intervention) with that three and Six months after the initiation of the intervention

• change on the useful microbiota of the autistic children ( probiotics)

  by DNA extraction kits of the fecal samples and Real-time PCR before and after interventions we will measure the change in the presence of the probiotics before and after the intervention

  ifference from the initial (before the intervention) with that three and Six months after the initiation of the intervention

Secondary Outcomes (6)

• Dates' effect on the change of the behavioral rating assessed by an Observation Checklist using the "Bailey Scales of Infant and Toddler Development

  The difference from the initial (before the intervention) with that three and Six months after the initiation of the intervention

• Dates' effect on the change of the mental development assessed by an Observation Checklist using the "Bailey Scales of Infant and Toddler Development"

  The difference from the initial (before the intervention) with that three and Six months after the initiation of the intervention

• Dates' effect on the change of the Psychomotor abilities assessed by the observational checklist using the "Bailey Scales of Infant and Toddler Development

  The difference from the initial (before the intervention) with that three and Six months after the initiation of the intervention

• Dates' effect on the changes of the level of the autism as assessed by the 5th edition of the DSM-V

  The difference from the initial (before the intervention) with that three and Six months after the initiation of the intervention

• Dates' effect on the changes of the severity of the autism as assessed by Childhood Autism Rating Scale (CARS) measure

  The difference from the initial (before the intervention) with that three and Six months after the initiation of the intervention

Study Arms (3)

Dates group 1

ACTIVE COMPARATOR

For the group of the date 1, Diagnosed autistic patients will be given three pieces of Dates will be given on daily basis for 12 weeks as follow: Three pieces (each about 10 -15 gm), of Dates, will be taken with breakfast or between breakfast and lunch as a test dose daily (without drinking any tea after it by at least one hour).

Other: Dates fruit as functional Food; Behavioral: behavioral modification and stimulation; Other: nutritional Guidance

Dates group 2

ACTIVE COMPARATOR

For the group of the date 2, Diagnosed autistic patients matched for age and sex will be given five pieces of Dates will be given on daily basis for 12 weeks as follow: five pieces (each about 10 -15 gm), of Dates, will be taken with breakfast or between breakfast and lunch as a test dose daily (without drinking any tea after it by at least one hour).

Other: Dates fruit as functional Food; Behavioral: behavioral modification and stimulation; Other: nutritional Guidance

Group 3

ACTIVE COMPARATOR

Group 3 (no- Dates fruit group): Diagnosed autistic patients matched for age and sex will not receive any dates

Behavioral: behavioral modification and stimulation; Other: nutritional Guidance

Interventions

Dates fruit as functional Food OTHER

Two groups will receive Dates; The number per group is dependant on the child age. For children aged 3-6 years; they will receive the minimum numbers of dates (3 pieces). For children aged more than 6-12 years will receive 5 pieces of Dates the choice of the minimum numbers of dates (3 pieces) in this current trial is based on a study that was done by Al Jaouni and his colleagues, 2019 which proved the effects of three pieces of Ajwa on infection, hospitalization, and survival among 26 pediatric cancer patients in a university hospital; for which their treatment outcome was improved due to their intake of this amount of Ajwa during their standard treatment

Dates group 1; Dates group 2

behavioral modification and stimulation BEHAVIORAL

Behavioral modification applied to the autistic children that is based on applied behavior analysis (ABA), a widely accepted approach that tracks a child's progress in improving his or her skills. We use Positive Behavioral and Support (PBS)

Dates group 1; Dates group 2; Group 3

nutritional Guidance OTHER

The nutritional education sessions are based on educating parents on providing their autistic children with a nutritious, balanced diet. Because children with ASD often have restricted diets as well as difficulty sitting through meal times, they may not be getting all the nutrients they need, particularly calcium and protein

Dates group 1; Dates group 2; Group 3

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Is not allergic to Dates (tested initially by one piece of Dates)
• Agrees to the intake of Dates fruits for at least 3 months
• Not participating in another study
• Signed the consent to participate in the study
• Caregiver consent was obtained for all the studied cases.

You may not qualify if:

• All subjects with other causes of mental sub-normality and/or delayed language
• Refuses intake of Dates
• Participating in another study
• Refused to sign the consent to participate in the study
• Patients who consumed probiotics and/or Dates for at least 4 weeks prior to the trial and/or antibiotics or laxatives for 6 months prior to the start.

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

National Research Centre

Giza, Giza Governorate, 12411, Egypt

Location

Related Publications (17)

• 1- World Health Organization (WHO). Autism Spectrum Disorders, Fact sheet, https://www.who.int/news-room/fact-sheets/detail/autism-spectrum-disorders, acessesd on 1-7-2019, 2018

  BACKGROUND

• Kohane IS, McMurry A, Weber G, MacFadden D, Rappaport L, Kunkel L, Bickel J, Wattanasin N, Spence S, Murphy S, Churchill S. The co-morbidity burden of children and young adults with autism spectrum disorders. PLoS One. 2012;7(4):e33224. doi: 10.1371/journal.pone.0033224. Epub 2012 Apr 12.

  PMID: 22511918 BACKGROUND

• McElhanon BO, McCracken C, Karpen S, Sharp WG. Gastrointestinal symptoms in autism spectrum disorder: a meta-analysis. Pediatrics. 2014 May;133(5):872-83. doi: 10.1542/peds.2013-3995.

  PMID: 24777214 BACKGROUND

• Kushak R., Buie T.: Intestinal disaccharidase deficiency in children with autism spectrum disorders. J. Pediatr. Gastroent. 2002; 35,:436.

  BACKGROUND

• Israelyan N, Margolis KG. Reprint of: Serotonin as a link between the gut-brain-microbiome axis in autism spectrum disorders. Pharmacol Res. 2019 Feb;140:115-120. doi: 10.1016/j.phrs.2018.12.023. Epub 2019 Jan 15.

  PMID: 30658882 BACKGROUND

• Li Q, Zhou JM. The microbiota-gut-brain axis and its potential therapeutic role in autism spectrum disorder. Neuroscience. 2016 Jun 2;324:131-9. doi: 10.1016/j.neuroscience.2016.03.013. Epub 2016 Mar 8.

  PMID: 26964681 BACKGROUND

• Meguid NA, Dardir AA, Abdel-Raouf ER, Hashish A. Evaluation of oxidative stress in autism: defective antioxidant enzymes and increased lipid peroxidation. Biol Trace Elem Res. 2011 Oct;143(1):58-65. doi: 10.1007/s12011-010-8840-9. Epub 2010 Sep 16.

  PMID: 20845086 BACKGROUND

• Perry G, Nunomura A, Harris S, Smith M, Salomon R., Is Autism a disease of oxidative stress.Oxidative stress in autism symposium, New York State, Institute for basic research in Developmental Disabilities. 2005; p. 15

  BACKGROUND

• Gebril OH, Meguid NA. HFE gene polymorphisms and the risk for autism in Egyptian children and impact on the effect of oxidative stress. Dis Markers. 2011;31(5):289-94. doi: 10.3233/DMA-2011-0830.

  PMID: 22048270 BACKGROUND

• Dar-ul-Iman Healing,. Food of the Prophet (Sallallaho Alayhi Wasallam) Available at: http://chishti.org/foods_of_the_prophet. acessesd on 1-7-2019, 2000

  BACKGROUND

• Marwat SK, Khan MA, Rehman F, Bhatti IU. Aromatic plant species mentioned in the Holy Qura'n and Ahadith and their ethnomedicinal importance. Pak J Nut. 2009;8: 1472-1479.

  BACKGROUND

• Eid N, Enani S, Walton G, Corona G, Costabile A, Gibson G, Rowland I, Spencer JP. The impact of date palm fruits and their component polyphenols, on gut microbial ecology, bacterial metabolites and colon cancer cell proliferation. J Nutr Sci. 2014 Oct 8;3:e46. doi: 10.1017/jns.2014.16. eCollection 2014.

  PMID: 26101614 BACKGROUND

• Mansouri A, Embarek G, Kokkalou E, Kefalas P. Phenolic profile and antioxidant activity of the Algerian ripe date palm fruit (Phoenix dactylifera) Food Chem. 2005;89:411-420.

  BACKGROUND

• Gu L, Kelm MA, Hammerstone JF, Beecher G, Holden J, Haytowitz D, Prior RL. Screening of foods containing proanthocyanidins and their structural characterization using LC-MS/MS and thiolytic degradation. J Agric Food Chem. 2003 Dec 3;51(25):7513-21. doi: 10.1021/jf034815d.

  PMID: 14640607 BACKGROUND

• Mirza MB, Syed FQ, Khan F, Elkady AI, Al-Attar AM, Hakeem KR. Ajwa Dates: A Highly Nutritive Fruit with the Impending Therapeutic Application. In: Plant and Human Health, Volume 3. Cham: Springer International Publishing; 2019;. 209-30.

  BACKGROUND

• Sheikh BY, Zihad SM, Sifat N, Uddin SJ, Shilpi JA, Hamdi OA, Hossain H, Rouf R, Jahan IA. Comparative study of neuropharmacological, analgesic properties and phenolic profile of Ajwah, Safawy and Sukkari cultivars of date palm (Phoenix dactylifera). Orient Pharm Exp Med. 2016;16(3):175-183. doi: 10.1007/s13596-016-0239-5. Epub 2016 Aug 16.

  PMID: 27746708 BACKGROUND

• Rahmani AH, Aly SM, Ali H, Babiker AY, Srikar S, Khan AA. Therapeutic effects of date fruits (Phoenix dactylifera) in the prevention of diseases via modulation of anti-inflammatory, anti-oxidant and anti-tumour activity. Int J Clin Exp Med. 2014 Mar 15;7(3):483-91. eCollection 2014.

  PMID: 24753740 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Functional Food; Behavior Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ammal M Metwally, PhD

  National Research Centre, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Dates and their constituents show a role in disease prevention through anti-oxidant, anti-inflammatory, anti-bacterial activity. Dates are considered a staple food item in the Middle East and North Africa and are also imported in Europe, the UK, and the USA. (12). Dates' therapeutic effect in the management of the disease via its anti-oxidant, anti-inflammatory effect and for the sake of autistic children, is worthy to point and essential to evaluate Dates as a good remedy for autistic children because it is inexpensive and easy to access.

Study Record Dates

• First Submitted: February 1, 2020
• First Posted: February 10, 2020
• Study Start: December 15, 2019
• Primary Completion: January 15, 2022
• Study Completion: April 15, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after the end of the project
• Access Criteria: the data will be accessed through a drive with a link

Locations

EG (1)