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Dates as a Functional Food for Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04261595
Recruitment Status : Active, not recruiting
First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Prof.Dr. Ammal Mokhtar Metwally, National Research Center, Egypt

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.


Condition or disease Intervention/treatment Phase
Autistic Spectrum Disorder Other: Dates fruit as functional Food Behavioral: behavioral modification and stimulation Other: nutritional Guidance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating Dates as a Functional Food for Autism Via Its Prebiotic Effect, Modulation of Anti-Inflammatory and Anti-Oxidative Activity.
Actual Study Start Date : December 15, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dates group 1
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
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

Behavioral: behavioral modification and stimulation
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)

Other: nutritional Guidance
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

Active Comparator: Dates group 2
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
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

Behavioral: behavioral modification and stimulation
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)

Other: nutritional Guidance
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

Active Comparator: Group 3
Group 3 (no- Dates fruit group): Diagnosed autistic patients matched for age and sex will not receive any dates
Behavioral: behavioral modification and stimulation
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)

Other: nutritional Guidance
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




Primary Outcome Measures :
  1. Dates' ability to change the oxidative stress of ASD [ Time Frame: ifference from the initial (before the intervention) with that three and Six months after the initiation of the intervention ]
    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

  2. change on the pathogenic microbiota of the autistic children as detected by traditional stool analysis through DNA extraction (quantitative PCR) of the fecal samples [ Time Frame: ifference from the initial (before the intervention) with that three and Six months after the initiation of the intervention ]
    Through the quantitative PCR (qPCR) for the change in the presence and absence of the targeted bacterial subgroups (including Bifidobacterium, lactobacillus, Clostridium, Sutterella)

  3. change on the useful microbiota of the autistic children ( probiotics) [ Time Frame: ifference from the initial (before the intervention) with that three and Six months after the initiation of the intervention ]
    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


Secondary Outcome Measures :
  1. Dates' effect on the change of the behavioral rating assessed by an Observation Checklist using the "Bailey Scales of Infant and Toddler Development [ Time Frame: The difference from the initial (before the intervention) with that three and Six months after the initiation of the intervention ]
    Mental Development, Psychomotor Development and Behavior Rating will be assessed by using the "Bailey Scales of Infant and Toddler Development", the cognitive, language, and motor abilities will be assessed; as well as social-emotional and adaptive behavior. Mental and psychomotor developmental quotients and mental age will be scored as well as the behavioral profile. The Bailey Screening Test is an Observation Checklist for 5 domains of development (cognitive, language, motor, social-emotional, & adaptive behavior).

  2. Dates' effect on the change of the mental development assessed by an Observation Checklist using the "Bailey Scales of Infant and Toddler Development" [ Time Frame: The difference from the initial (before the intervention) with that three and Six months after the initiation of the intervention ]
    Mental Development, Psychomotor Development and Behavior Rating will be assessed by using the "Bailey Scales of Infant and Toddler Development", the cognitive, language, and motor abilities will be assessed; as well as social-emotional and adaptive behavior. Mental and psychomotor developmental quotients and mental age will be scored as well as the behavioral profile. The Bailey Screening Test is an Observation Checklist for 5 domains of development (cognitive, language, motor, social-emotional, & adaptive behavior).

  3. Dates' effect on the change of the Psychomotor abilities assessed by the observational checklist using the "Bailey Scales of Infant and Toddler Development [ Time Frame: The difference from the initial (before the intervention) with that three and Six months after the initiation of the intervention ]
    Mental Development, Psychomotor Development and Behavior Rating will be assessed by using the "Bailey Scales of Infant and Toddler Development", the cognitive, language, and motor abilities will be assessed; as well as social-emotional and adaptive behavior. Mental and psychomotor developmental quotients and mental age will be scored as well as the behavioral profile. The Bailey Screening Test is an Observation Checklist for 5 domains of development (cognitive, language, motor, social-emotional, & adaptive behavior).

  4. Dates' effect on the changes of the level of the autism as assessed by the 5th edition of the DSM-V [ Time Frame: The difference from the initial (before the intervention) with that three and Six months after the initiation of the intervention ]
    comparing changes the severity of autism as a result of interventions according Diagnostic and statistical manual of mental disorders, 5th ed. (DSM-V) criteria it measure specific ASD symptom severity All core features of ASD are included: socialisation impairments, communication deficits and repetitive or restricted interests, including sensory abnormalities. After a period of interactive play, the observer rates the child's behaviour, comparing it to that of his/her age group. Each item is given a numerical score of '0' (indicating no impairment), '1' (indicating mild impairment), or '2' (indicating severe impairment)

  5. Dates' effect on the changes of the severity of the autism as assessed by Childhood Autism Rating Scale (CARS) measure [ Time Frame: The difference from the initial (before the intervention) with that three and Six months after the initiation of the intervention ]
    comparing changes the severity of autism as a result of interventions according to CARS.Each item on the Clinician-Rated Severity of Autism Spectrum and Social Communication Disorders measure is rated on a 4-point scale (Level 0=None; Level 1=Mild/Requiring support; Level 2=Moderate/Requiring SUBSTANTIAL support; and Level 3=Severe/Requiring VERY SUBSTANTIAL support).

  6. Dates' effect on the change on the dietary intake using the Food frequency questionnaire, 24-hour dietary recall, Dietary record [ Time Frame: The difference from the initial (before the intervention) with that three and Six months after the initiation of the intervention ]
    comparing changes on eating behaviors as assessed by the 24 hours intake and food pattern. Dietary intake is difficult to measure, and any single method cannot assess dietary exposure perfectly. The 24HR, and FFQ are subjective estimates. Recently, it has been suggested that a combination of methods, such as the FFQ with 24HR be used to obtain more accurate estimates of dietary intakes than that of individual methods. They are widely used as the primary dietary assessment tool in epidemiological studies..



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261595


Locations
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Egypt
National Research Centre
Giza, Al Jizah, Egypt, 12411
Sponsors and Collaborators
National Research Center, Egypt
Investigators
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Principal Investigator: Ammal M Metwally, PhD National research centre

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

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Responsible Party: Prof.Dr. Ammal Mokhtar Metwally, Principal Investigator, National Research Center, Egypt
ClinicalTrials.gov Identifier: NCT04261595    
Other Study ID Numbers: 12060158
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: after the end of the project
Access Criteria: the data will be accessed through a drive with a link

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof.Dr. Ammal Mokhtar Metwally, National Research Center, Egypt:
Dates
Autism
microbiota
antioxidant
anti- inflammatory
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Anti-Inflammatory Agents