Metabolic Processes in Adults and Adolescents With Autism Spectrum Disorder

NCT02733120 | Completed

• 1 other identifier: 2015-0542
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Tryptophan turnover

  2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes

Secondary Outcomes (17)

• leucine turnover

  2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes

• Whole body myofibrillar protein breakdown rate (reflecting muscle protein breakdown)

  2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes

• glutathione turnover

  2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes

• hydroxyproline breakdown (reflecting collagen breakdown)

  2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes

• glutamate turnover

  2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210 and 240 ± 5 minutes

Study Arms (2)

Healthy matched controls

EXPERIMENTAL

Study Day: The subject will arrive fasted. A catheter will be inserted in the arm for stable isotope infusion and blood sampling. The hand of the arm used for blood sampling will be placed in a thermostatically controlled warmed box that heats the air. Immediately after a baseline blood sample is taken, an infusion with stable isotopes will be administered by the research nurse. Stable isotopes are given to measure amino acid metabolism. Blood samples will be collected before and/or after infusion. Subjects will be asked to complete a list of questions regarding quality of life, mood and depression, diet.

Other: stable isotope infusion

Adults with Autism Spectrum Disorder

EXPERIMENTAL

The subject will arrive fasted. A catheter will be inserted in the arm for stable isotope infusion and blood sampling. The hand of the arm used for blood sampling will be placed in a thermostatically controlled warmed box that heats the air. Immediately after a baseline blood sample is taken, an infusion with stable isotopes will be administered by the research nurse. Stable isotopes are given to measure amino acid metabolism. Blood samples will be collected before and/or after infusion. Subjects will be asked to complete a list of questions regarding quality of life, mood and depression, diet.

Other: stable isotope infusion

Interventions

stable isotope infusion OTHER

stable 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

Adults with Autism Spectrum Disorder; Healthy matched controls

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University-CTRAL

College Station, Texas, 77843, United States

Location

Related Publications (1)

• Wierzchowska-McNew RA, Engelen MPKJ, Thaden JJ, Ten Have GAM, Deutz NEP. Obesity- and sex-related metabolism of arginine and nitric oxide in adults. Am J Clin Nutr. 2022 Dec 19;116(6):1610-1620. doi: 10.1093/ajcn/nqac277.

  PMID: 36166849 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Marielle Engelen, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: April 11, 2016
• Study Start: December 3, 2015
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

US (1)