Down SyndromeNEURODIET-DSAANCT07165509

Neuro-Nutrition to Support Physiological Function and Cognitive Skills in People With Down Syndrome, Autism Spectrum Disorder, and ADHD

A study testing T-2 Nutritional Supplement and Structured Dietary Program in people with Down Syndrome and Autism Spectrum Disorder, run by Elizabeth Guadalupe Ibarra Coronado at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 2 to 35 years
Conditions the study is for: Down Syndrome, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder (ADHD)
What is being tested?: T-2 Nutritional Supplement and Structured Dietary Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 1 siteMexico
Study dates: 26 Mar 2022to 1 May 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 35 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age 2-35 years at enrollment.
Clinical diagnosis of Down syndrome (DS), Autism Spectrum Disorder (ASD/TEA), or Attention-Deficit/Hyperactivity Disorder (ADHD/TDAH). For DS, written karyotype confirmation; for ASD/ADHD, clinical criteria (DSM) and standardized scales per protocol (e.g., Conners).
Parent/guardian able to provide written informed consent prior to study procedures.
Willingness to comply with the assigned structured diet and/or supplement regimen and study visits.

Who cannot join

Individuals outside 2-35 years or without DS/ASD/ADHD diagnosis.
Healthy volunteers (no target neurodevelopmental condition).
Inability or unwillingness to adhere to the dietary program and/or supplement (the team may request withdrawal for non-adherence as per protocol).
Lack of informed consent from parent/guardian.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Instituto Mexicano de Medicina Integral de Sueño
Mexico City, 03100

Other trials in Mexico

About this study

Official title: Neuro-Nutrition as Support for Physiological Function and Cognitive Abilities in Individuals With Down Syndrome, Autism Spectrum Disorder, and Attention-Deficit/Hyperactivity Disorder

This study aimed to evaluate the impact of a specialized nutritional intervention on physiological performance, sleep quality, and cognitive abilities in individuals with neurodevelopmental disorders, specifically Down syndrome, autism spectrum disorders (ASD), and attention deficit disorder (ADD/ADHD). The intervention consisted of a modified diet protocol combined with an investigational nutritional formulation administered over a fixed intervention period. Outcomes included cognitive performance measures, sleep parameters, and selected physiological biomarkers.

Read the detailed description

The Neuroalimentación protocol integrates dietary modification and targeted nutritional supplementation to support metabolic, cognitive, and physiological functions in populations with neurodevelopmental conditions. This interventional study was conducted as a longitudinal, prospective trial including participants diagnosed with Down syndrome, autism spectrum disorders, or ADHD. Participants received the intervention for a defined period, during which outcomes related to cognitive performance, physiological markers, and sleep quality were evaluated using standardized neuropsychological tests, polysomnography, and laboratory analyses.

The trial sought to determine whether such dietary and supplementation strategies could enhance functional performance and quality of life in these populations.

Conditions: Down Syndrome, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder (ADHD)
Being tested: T-2 Nutritional Supplement, Structured Dietary Program
Keywords: Trisomy 21, ASD, ADHD, Neuro-nutrition, Structured diet, Dietary supplement, BRIEF, NEUROPSI Attention and Memory, Polysomnography, Sleep efficiency index, Apnea-hypopnea index, LDL cholesterol, C-reactive protein
Medical subject headings: Down Syndrome, Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T-2 Nutritional SupplementDietary supplement
Also called Complemento Alimenticio T-2, T-2
Nutritional supplement labeled "T-2"; dose 23 g twice daily, as specified in the protocol. Used only in the arm "T-2 Supplement + Structured Diet."
Structured Dietary ProgramBehavioural
Also called Structured Diet, Neuro-Nutrition Diet Program
Rigorous, structured dietary intervention applied according to the study protocol. Used in the arms "T-2 Supplement + Structured Diet" and "Structured Diet Only."

Study groups in NCT07165509
Study group	Role	What they receive
T-2 Supplement + Structured Diet	Experimental	Participants receive the T-2 nutritional supplement (23 g twice daily) plus a structured dietary program. Arms run in parallel within each diagnostic cohort (Down syndrome, ASD, ADHD). Receives: Dietary Supplement: T-2 Nutritional Supplement; Behavioral: Structured Dietary Program
Structured Diet Only	Active comparator	Participants follow the structured dietary intervention without the T-2 supplement. Receives: Behavioral: Structured Dietary Program
Control	No intervention	Participants receive no T-2 supplement and no structured dietary program (usual diet).

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Executive Function (BRIEF Global Executive Composite [GEC] T-score)
Parent/caregiver-rated BRIEF; Global Executive Composite (GEC) T-score (normative mean 50, SD 10). Change is calculated as follow-up minus baseline; unit: T-score.
Measured: Baseline to 12 months

Secondary outcomes (1)

Change in NEUROPSI Attention and Memory Total Standardized Score
NEUROPSI Attention and Memory battery; standardized total score covering verbal/visual short- and long-term memory, episodic memory, attention/concentration, and motor skills; unit: standardized score/percentile per test manual.
Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 20221 May 2023

First posted10 Sep 2025
Study start26 Mar 2022
Primary completion31 Dec 2022
Study completion1 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Down SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Three-arm parallel study. Within each diagnostic cohort (Down syndrome, autism spectrum disorder, and ADHD), participants were assigned to one of three groups followed concurrently: (1) T-2 nutritional supplement (23 g twice daily) plus a structured dietary program; (2) structured diet only; or (3) no supplement and no structured diet (control). Age range 2-35 years; no crossover.
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07165509
Sponsor's protocol ID: CEI-000002-43
Other IDs: 157118
Acronym: NEURODIET-DSAA
Status last verified: Sep 2025
First submitted: 3 Sep 2025
Last updated: 10 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared because the informed consent approved by the research ethics committee did not authorize secondary sharing or posting of participant-level data. The dataset includes minors and sensitive health information; sharing would require re-consent and/or new ethics approval, which is not feasible for this completed study.

Publications

Gioia GA, Isquith PK, Retzlaff PD, Espy KA. Confirmatory factor analysis of the Behavior Rating Inventory of Executive Function (BRIEF) in a clinical sample. Child Neuropsychol. 2002 Dec;8(4):249-57. doi: 10.1076/chin.8.4.249.13513.
PubMed 12759822
MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950
First MB, Pincus HA. The DSM-IV Text Revision: rationale and potential impact on clinical practice. Psychiatr Serv. 2002 Mar;53(3):288-92. doi: 10.1176/appi.ps.53.3.288.
PubMed 11875221
Ostrosky-Solis F, Ardila A, Rosselli M. NEUROPSI: a brief neuropsychological test battery in Spanish with norms by age and educational level. J Int Neuropsychol Soc. 1999 Jul;5(5):413-33. doi: 10.1017/s1355617799555045.
PubMed 10439587
Allik H, Larsson JO, Smedje H. Sleep patterns of school-age children with Asperger syndrome or high-functioning autism. J Autism Dev Disord. 2006 Jul;36(5):585-95. doi: 10.1007/s10803-006-0099-9.
PubMed 16617404
Hering E, Epstein R, Elroy S, Iancu DR, Zelnik N. Sleep patterns in autistic children. J Autism Dev Disord. 1999 Apr;29(2):143-7. doi: 10.1023/a:1023092627223.
PubMed 10382134
Accardo JA, Marcus CL, Leonard MB, Shults J, Meltzer LJ, Elia J. Associations between psychiatric comorbidities and sleep disturbances in children with attention-deficit/hyperactivity disorder. J Dev Behav Pediatr. 2012 Feb;33(2):97-105. doi: 10.1097/DBP.0b013e31823f6853.
PubMed 22261833
Cotton S, Richdale A. Brief report: parental descriptions of sleep problems in children with autism, Down syndrome, and Prader-Willi syndrome. Res Dev Disabil. 2006 Mar-Apr;27(2):151-61. doi: 10.1016/j.ridd.2004.12.003. Epub 2005 Jun 21.
PubMed 15975763
Bittles AH, Glasson EJ. Clinical, social, and ethical implications of changing life expectancy in Down syndrome. Dev Med Child Neurol. 2004 Apr;46(4):282-6. doi: 10.1017/s0012162204000441. No abstract available.
PubMed 15077706
Billstedt E, Gillberg IC, Gillberg C. Autism after adolescence: population-based 13- to 22-year follow-up study of 120 individuals with autism diagnosed in childhood. J Autism Dev Disord. 2005 Jun;35(3):351-60. doi: 10.1007/s10803-005-3302-5.
PubMed 16119476
Bieberich AA, Morgan SB. Brief report: affective expression in children with autism or Down syndrome. J Autism Dev Disord. 1998 Aug;28(4):333-8. doi: 10.1023/a:1026016804357. No abstract available.
PubMed 9711490

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Down Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neuro-Nutrition as Support for Physiological Function and Cognitive Abilities in Individuals With Down Syndrome, Autism Spectrum Disorder, and Attention-Deficit/Hyperactivity Disorder
ClinicalTrials.gov ID: NCT07165509
Acronym / sponsor ID: NEURODIET-DSAA / CEI-000002-43
Conditions: Down Syndrome, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: Trisomy 21, ASD, ADHD, Neuro-nutrition, Structured diet, Dietary supplement, BRIEF, NEUROPSI Attention and Memory
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Elizabeth Guadalupe Ibarra CoronadoResearch network
Collaborators: Universidad Nacional Autonoma de Mexico
Study start: 26 Mar 2022 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 1 May 2023 (actual)
First posted: 10 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The trial sought to determine whether such dietary and supplementation strategies could enhance functional performance and quality of life in these populations.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Three-arm parallel study. Within each diagnostic cohort (Down syndrome, autism spectrum disorder, and ADHD), participants were assigned to one of three groups followed concurrently: (1) T-2 nutritional supplement (23 g twice daily) plus a structured dietary program; (2) structured diet only; or (3) no supplement and no structured diet (control). Age range 2-35 years; no crossover.

Arm	Type	Receives
T-2 Supplement + Structured Diet	Experimental	Dietary Supplement: T-2 Nutritional Supplement, Behavioral: Structured Dietary ProgramParticipants receive the T-2 nutritional supplement (23 g twice daily) plus a structured dietary program. Arms run in parallel within each diagnostic cohort (Down syndrome, ASD, ADHD).
Structured Diet Only	Active comparator	Behavioral: Structured Dietary ProgramParticipants follow the structured dietary intervention without the T-2 supplement.
Control	No intervention	–Participants receive no T-2 supplement and no structured dietary program (usual diet).

Who may qualify

Ages: 2 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Age 2-35 years at enrollment.
Clinical diagnosis of Down syndrome (DS), Autism Spectrum Disorder (ASD/TEA), or Attention-Deficit/Hyperactivity Disorder (ADHD/TDAH). For DS, written karyotype confirmation; for ASD/ADHD, clinical criteria (DSM) and standardized scales per protocol (e.g., Conners).
Parent/guardian able to provide written informed consent prior to study procedures.
Willingness to comply with the assigned structured diet and/or supplement regimen and study visits.

Key exclusion criteria (4 listed)

Individuals outside 2-35 years or without DS/ASD/ADHD diagnosis.
Healthy volunteers (no target neurodevelopmental condition).
Inability or unwillingness to adhere to the dietary program and/or supplement (the team may request withdrawal for non-adherence as per protocol).
Lack of informed consent from parent/guardian.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
T-2 Nutritional SupplementAlso: Complemento Alimenticio T-2, T-2Nutritional supplement labeled "T-2"; dose 23 g twice daily, as specified in the protocol. Used only in the arm "T-2 Supplement + Structured Diet."	Dietary supplement	T-2 Supplement + Structured Diet
Structured Dietary ProgramAlso: Structured Diet, Neuro-Nutrition Diet ProgramRigorous, structured dietary intervention applied according to the study protocol. Used in the arms "T-2 Supplement + Structured Diet" and "Structured Diet Only."	Behavioural	Structured Diet Only, T-2 Supplement + Structured Diet

Primary outcome

Change in Executive Function (BRIEF Global Executive Composite [GEC] T-score)
Time frame: Baseline to 12 months
Parent/caregiver-rated BRIEF; Global Executive Composite (GEC) T-score (normative mean 50, SD 10). Change is calculated as follow-up minus baseline; unit: T-score.

1 secondary outcome

Change in NEUROPSI Attention and Memory Total Standardized Score
Time frame: Baseline to 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
Background: PubMed 12759822Gioia GA, Isquith PK, Retzlaff PD, Espy KA. Confirmatory factor analysis of the Behavior Rating Inventory of Executive Function (BRIEF) in a clinical sample. Child Neuropsychol. 2002 Dec;8(4):249-57. doi: 10.1076/chin.8.4.249.13513.
Background: PubMed 14258950MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
Background: PubMed 11875221First MB, Pincus HA. The DSM-IV Text Revision: rationale and potential impact on clinical practice. Psychiatr Serv. 2002 Mar;53(3):288-92. doi: 10.1176/appi.ps.53.3.288.
Background: PubMed 10439587Ostrosky-Solis F, Ardila A, Rosselli M. NEUROPSI: a brief neuropsychological test battery in Spanish with norms by age and educational level. J Int Neuropsychol Soc. 1999 Jul;5(5):413-33. doi: 10.1017/s1355617799555045.
Background: PubMed 16617404Allik H, Larsson JO, Smedje H. Sleep patterns of school-age children with Asperger syndrome or high-functioning autism. J Autism Dev Disord. 2006 Jul;36(5):585-95. doi: 10.1007/s10803-006-0099-9.
Background: PubMed 10382134Hering E, Epstein R, Elroy S, Iancu DR, Zelnik N. Sleep patterns in autistic children. J Autism Dev Disord. 1999 Apr;29(2):143-7. doi: 10.1023/a:1023092627223.
Background: PubMed 22261833Accardo JA, Marcus CL, Leonard MB, Shults J, Meltzer LJ, Elia J. Associations between psychiatric comorbidities and sleep disturbances in children with attention-deficit/hyperactivity disorder. J Dev Behav Pediatr. 2012 Feb;33(2):97-105. doi: 10.1097/DBP.0b013e31823f6853.
Background: PubMed 15975763Cotton S, Richdale A. Brief report: parental descriptions of sleep problems in children with autism, Down syndrome, and Prader-Willi syndrome. Res Dev Disabil. 2006 Mar-Apr;27(2):151-61. doi: 10.1016/j.ridd.2004.12.003. Epub 2005 Jun 21.
Background: PubMed 15077706Bittles AH, Glasson EJ. Clinical, social, and ethical implications of changing life expectancy in Down syndrome. Dev Med Child Neurol. 2004 Apr;46(4):282-6. doi: 10.1017/s0012162204000441. No abstract available.
Background: PubMed 16119476Billstedt E, Gillberg IC, Gillberg C. Autism after adolescence: population-based 13- to 22-year follow-up study of 120 individuals with autism diagnosed in childhood. J Autism Dev Disord. 2005 Jun;35(3):351-60. doi: 10.1007/s10803-005-3302-5.
Background: PubMed 9711490Bieberich AA, Morgan SB. Brief report: affective expression in children with autism or Down syndrome. J Autism Dev Disord. 1998 Aug;28(4):333-8. doi: 10.1023/a:1026016804357. No abstract available.
Individual participant dataSharing planned: No. Individual participant data will not be shared because the informed consent approved by the research ethics committee did not authorize secondary sharing or posting of participant-level data. The dataset includes minors and sensitive health information; sharing would require re-consent and/or new ethics approval, which is not feasible for this completed study.

Related trials for Down Syndrome

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing T-2 Nutritional Supplement and Structured Dietary Program in people with Down Syndrome and Autism Spectrum Disorder, run by Elizabeth Guadalupe Ibarra Coronado at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Executive Function (BRIEF Global Executive Composite [GEC] T-score) (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07165509, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.