Metabolic Processes in Adults and Adolescents With Autism Spectrum Disorder



Status:Active, not recruiting
Conditions:Neurology, Psychiatric, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:16 - Any
Updated:1/18/2019
Start Date:October 2015
End Date:September 2020

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Study on Metabolic Processes and Cognitive Functions in Adults and Adolescents With Autism Spectrum Disorder

The objective of this study is to gain preliminary information and knowledge on metabolic
profile in ASD. The benefit of this study will be to expand our insight of the potential
relationship in metabolic processes and neuropsychological functions in ASD. For example,
based on the obtained data of the study we can determine whether there is a link between the
tryptophan pathway and cognitive functions in autism. The project is based on a systematic
and multidisciplinary approach using tracers for delineating the mechanism by which the
metabolism of amino acids like TRP is involved in affective and cognitive functions in ASD.
Using an innovative approach to the evaluation of amino acids has not been used in adults
with ASD. In addition, the obtained data of the study holds promise to develop specific
markers (metabolic and/or neuropsychological) for guiding the identification those
individuals with increased risk of developing mood disturbances or cognitive impairment, and
for predicting the therapeutic effect of a specific nutritional interventions in subjects
with ASD.

This study investigates the metabolic profile of different amino acids and cognitive
functions in adults and adolescents with ASD in comparison with age- and gender-matched
healthy young adults. The study involves 1 screening visit of approximately 2 hours and 1
study day of 5 hours

The objective is to explore changes in amino acids (e.g. TRP pathway) in ASD and evaluate the
function of TRP in neuropsychological functions by using the technique of stable isotope and
our newly developed 'single pulse method' with multiple amino acid and keto-acid isotopes.

The aim of this study is to determine the underlying mechanism by which the metabolism of
amino acids such as TRP are involved in mood and cognitive functions in ADS.

Inclusion Criteria Healthy:

- Healthy male or female according to the investigator's or appointed staff's judgment

- Age 16 years or older

- Ability to walk, sit down and stand up independently

- Ability to lie in supine or elevated position for 4 hours

- Willingness and ability to comply with the protocol

Inclusion criteria subjects with Autism Spectrum Disorder (ASD):

- Healthy high functioning person diagnosed with autism spectrum disorder

- Age 16 years or older

- Ability to walk, sit down and stand up independently

- Ability to lie in supine or elevated position for 4 hours

- Willingness and ability to comply with the protocol

Exclusion Criteria:

- Any condition that may interfere with the definition 'healthy subject' according to
the investigator's judgment (for healthy group)

- Failure to give informed consent

- Established diagnosis of Insulin Dependent Diabetes Mellitus

- Metabolic diseases, including hepatic or renal disorders

- Presence of acute illness or metabolically unstable chronic illness

- Presence of fever within the last 3 days

- Pre-planned surgery of procedures that would interfere with the conduct of the study

- Any other condition according to the PI or study physician that would interfere with
proper conduct of the study / safety of the patient

- Current alcohol or drug abuse

- Use of protein or amino acid containing nutritional supplements within 5 days prior to
the study days

- Use of long-term oral corticosteroids or short course of oral cortico-steroids 4 weeks
preceding first test day

- Body Mass Index of < 18.5 or ≥ 40 kg/m2

- Montreal Cognitive Assessment score of < 20
We found this trial at
1
site
College Station, Texas 77845
Phone: 979-220-2282
?
mi
from
College Station, TX
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