Clinical Trials Directory

Trials / Completed

CompletedNCT02733120

Metabolic Processes in Adults and Adolescents With Autism Spectrum Disorder

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Texas A&M University · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERstable isotope infusionstable isotopes such as 15N2, TRP, 2H3-Leucine, L-\[2H3\]-3-Methylhistidine, 2H2-Glycine, 2-D-hydroxyproline, 1-13C-ketoisocaproic acid (KIC), L-\[Guanido-15N2\]-Arginine, L-\[ureido-13C-2H2\]-Citrulline), L-Glutamine-amide-15N, 1,2-13C2-L-Glutamic acid, 1,2-13C2Taurine, and 13C-Urea is given IV simultaneously

Timeline

Start date
2015-12-03
Primary completion
2017-10-30
Completion
2017-10-30
First posted
2016-04-11
Last updated
2025-09-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02733120. Inclusion in this directory is not an endorsement.