A Study Looking at How Well Children With Autism Spectrum Disorder on Medications Like Having More Protein

Autism Spectrum Disorder Clinical Trial

Official title:

A Feasibility and Acceptability Study of Elevated Protein Dietary Intake for Children Diagnosed With Autism Spectrum Disorder (ASD) While on Atypical Antipsychotic Medication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03708614
• Other study ID #: REB 18-781
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2018
• Est. completion date: June 2020

Study information

• Verified date: August 2019
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: Lorry Chen, Honors BSc.
• Phone: 416-425-6220
• Email: lchen[@]hollandbloorview.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Antipsychotic medications are commonly prescribed in children and adults with ASD (Curtin, Jojic & Bandini, 2014). But weight gain has been known to be one of the less desirable effects of these medications, increasing one's risk for overweight and obesity. Based on experience in Holland Bloorview's Nutrition Clinic, working with a dietitian to follow specific dietary advice, such as having more protein while keeping the amount of calories the same, may be a possible and useful way to limit weight gain.

This study's objective is to evaluate the feasibility (study designs, methods, processes) and acceptability (client/family satisfaction, perceived effectiveness) of a controlled energy diet with elevated protein intake in children and youth with ASD who are currently taking prescribed atypical antipsychotic medication.

Description:

The use of psychotropic medication in children and youth with Autism Spectrum Disorder (ASD) to treat symptoms of aggression, irritability and related behavioural problems has become increasingly common in recent years. Data obtained from clinical and nationally representative populations of children demonstrate that approximately 30%-60% of children with ASD are prescribed at least one psychotropic medication, and 10% are prescribed more than three medications at the same time (Curtin, Jojic & Bandini, 2014).

Weight gain, which is one of the harmful effects of psychotropic medication, is likely one of the most understood risk factors for obesity in children and adults with ASD. In a systematic review and meta-analysis of double-blinded, randomized, controlled trials studying the metabolic adverse effects of atypical antipsychotics in children and adolescents under 18 years of age, risperidone, olanzapine and aripiprazole were associated with statistically significant weight gain compared with placebo (Almandil et al., 2013). Similar findings were reported from a review of literature, using PubMed, on weight gain and increase of BMI among children and adolescents (0-18 years old) treated with antipsychotic medications (Martinez-Ortega et al., 2013).

Although clinical trials with different agents have been conducted in an attempt to address weight gain in individuals on psychotropic medications, no established treatments or preventative measures have been developed to combat psychotropic-induced weight gain (PIWG) to date (Curtin, Jojic & Bandini, 2014). A review of published literature using PubMed yielded limited and mixed results for using Metformin as the intervention for the treatment in combating PIWG (Anagostou et al., 2016; Handen et al., 2017). Based on clinical experience in Holland Bloorview's Nutrition Clinic, controlled energy intake combined with elevated protein intake (CEEP) may represent an effective and practical strategy for limiting weight gain.

Potential beneficial outcomes associated with protein ingestion include: a) increased satiety, which is being satisfactorily full - protein generally increases satiety to a greater extent than carbohydrate or fat and may facilitate a reduction in energy consumption; b) increased thermogenesis, which is the production of heat in the body - higher protein diets are associated with an increase in thermogenesis, which also influences satiety and increases energy expenditure; and c) maintenance or growth of fat-free mass (muscle) - an elevated protein diet may provide an increase effect on muscle protein synthesis in some individuals, favouring the retention of lean muscle mass while improving metabolic profile (Paddon-Jones et al., 2018).

This study's primary objective is to evaluate the feasibility (study designs, methods, processes) and acceptability (client/family satisfaction, perceived effectiveness) of a controlled energy diet with elevated protein intake in children and youth with ASD who are currently taking prescribed atypical antipsychotic medication.

Children and youth, ages 6-17 years old, with ASD (n=10) on atypical antipsychotic medication will be exposed to specific nutrition recommendations involving CEEP for ten consecutive weeks. Each participant and parent/guardian will work collaboratively with the RD/RA to formulate strategies to slowly increase protein intake in the range of 20-30% of total caloric intake and ensure consistent energy intake. Data will be collected through food records, anthropometric measurements and informal post-intervention interviews to measure the feasibility and acceptability of the study processes and elevated protein dietary changes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Child Inclusion Criteria:

• Diagnosis of ASD

• Currently taking one or more atypical antipsychotic medication

• Ages 6-17 years old

• Enrolment as an active client in a Psychopharmacology Clinic at Holland Bloorview

• Accepts all food, based on the SOS Feeding Approach: Defining Picky vs. Problem Eaters by Kay Toomey (2017) - has no significant food aversions; will accept new foods on plate, usually can touch or taste; and consumes one or more foods from all food groups, varying in textures

• Can communicate in English

• Has access to a telephone

2. Parent/guardian inclusion criteria:

• Provides care to study participant

• Can communicate in English

• Able to complete food records

• Has access to a telephone

Exclusion Criteria:

a) Child exclusion criteria:

• Medical condition that contradicts elevated protein intake

• Has significant food aversions

• Has any food allergies

• Currently participating in another clinical study that would interfere with anticipated endpoints and outcome measurements

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Other:
• Controlled energy diet with elevated protein intake
Participants will be counseled to elevate protein and control energy intake for ten consecutive weeks. Protein intake will be increased in the range of 20-30% of total daily caloric intake. Each participant's diet will also be modified to implement controlled energy intake. Controlled energy intake will be defined as being isocaloric with the participant's current dietary intake.

Locations

Country	Name	City	State
Canada	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Almandil NB, Liu Y, Murray ML, Besag FM, Aitchison KJ, Wong IC. Weight gain and other metabolic adverse effects associated with atypical antipsychotic treatment of children and adolescents: a systematic review and meta-analysis. Paediatr Drugs. 2013 Apr;15(2):139-50. doi: 10.1007/s40272-013-0016-6. Review. — View Citation

Anagnostou E, Aman MG, Handen BL, Sanders KB, Shui A, Hollway JA, Brian J, Arnold LE, Capano L, Hellings JA, Butter E, Mankad D, Tumuluru R, Kettel J, Newsom CR, Hadjiyannakis S, Peleg N, Odrobina D, McAuliffe-Bellin S, Zakroysky P, Marler S, Wagner A, Wong T, Macklin EA, Veenstra-VanderWeele J. Metformin for Treatment of Overweight Induced by Atypical Antipsychotic Medication in Young People With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Sep 1;73(9):928-37. doi: 10.1001/jamapsychiatry.2016.1232. Erratum in: JAMA Psychiatry. 2016 Dec 1;73(12):1295. — View Citation

Curtin C, Jojic M, Bandini LG. Obesity in children with autism spectrum disorder. Harv Rev Psychiatry. 2014 Mar-Apr;22(2):93-103. doi: 10.1097/HRP.0000000000000031. Review. — View Citation

Handen BL, Anagnostou E, Aman MG, Sanders KB, Chan J, Hollway JA, Brian J, Arnold LE, Capano L, Williams C, Hellings JA, Butter E, Mankad D, Tumuluru R, Kettel J, Newsom CR, Peleg N, Odrobina D, McAuliffe-Bellin S, Marler S, Wong T, Wagner A, Hadjiyannakis S, Macklin EA, Veenstra-VanderWeele J. A Randomized, Placebo-Controlled Trial of Metformin for the Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorder: Open-Label Extension. J Am Acad Child Adolesc Psychiatry. 2017 Oct;56(10):849-856.e6. doi: 10.1016/j.jaac.2017.07.790. Epub 2017 Aug 19. — View Citation

Martínez-Ortega JM, Funes-Godoy S, Díaz-Atienza F, Gutiérrez-Rojas L, Pérez-Costillas L, Gurpegui M. Weight gain and increase of body mass index among children and adolescents treated with antipsychotics: a critical review. Eur Child Adolesc Psychiatry. 2013 Aug;22(8):457-79. doi: 10.1007/s00787-013-0399-5. Epub 2013 Mar 17. Review. — View Citation

Paddon-Jones D, Westman E, Mattes RD, Wolfe RR, Astrup A, Westerterp-Plantenga M. Protein, weight management, and satiety. Am J Clin Nutr. 2008 May;87(5):1558S-1561S. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caloric and protein intake	Average caloric (kcal) and protein (g) intake - comparison of three day food records measured at the time of enrolment and during week 10 of intervention implementation	At the time of study enrolment (week 0) and during week 10 of intervention implementation (week 10)
Primary	Pre- (at time of study enrolment) and post-intervention anthropometric measurements	Weight in kilograms - to calculate weight changes and BMI	Measured at the time of study enrolment (week 0) and after ten weeks of intervention (week 11), assessed up to 11 weeks
Primary	Pre- (at time of study enrolment) and post-intervention anthropometric measurements	Height in centimetres - to calculate BMI	Measured at the time of study enrolment (week 0) and after ten weeks of intervention (week 11), assessed up to 11 weeks
Primary	Pre- (at time of study enrolment) and post-intervention anthropometric measurements	Skinfold (triceps and subscapular) measurements in millimetres	Measured at the time of study enrolment (week 0) and after ten weeks of following the intervention (week 11), assessed up to 11 weeks
Primary	Post-intervention interview with participants and family	Qualitative interview (guided using semi-structured format) to gain insight into successful strategies and potential barriers to consistently implement elevated protein dietary changes	Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11)
Primary	Study feasibility (designs, methods, processes)	Recruitment rates - comparisons between (i) number of patients screened; (ii) number of eligible patients identified from clinic; (iii) number of eligible patients approached; (iv) number of patients who agreed to further contact; and (v) number of participants consented and enrolled in the study.	During the screening and recruitment process (anticipated duration of 1-1.5 months)
Primary	Study feasibility (designs, methods, processes)	Retention rate - comparison between (i) number of participants enrolled at the start of the study; and (ii) number of participants enrolled at the end of study.	Measurements taken at the start of the study during enrolment and at study completion (anticipated duration of 5 months)
Primary	Study feasibility (designs, methods, processes)	Completion rates - Number of participants who completed the three-day food records	Measured at the time of study enrolment (week 0) and after ten weeks of intervention (week 11), assessed up to 11 weeks
Primary	Study feasibility (designs, methods, processes)	Qualitative interview (guided using semi-structured format) to assess the participants' perspectives on the acceptability and feasibility of completing food records	Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11)
Primary	Study feasibility (designs, methods, processes)	Qualitative interview (guided using semi-structured format) to assess the participants' perspectives on the acceptability and feasibility of attending on-site visits for anthropometric measurements	Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11)
Primary	Study feasibility (designs, methods, processes)	Qualitative interview (guided using semi-structured format) to assess the participants' perspectives on the acceptability and feasibility of following-up with the RA via phone during intervention implementation	Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11)
Primary	Study feasibility (designs, methods, processes)	Qualitative interview (guided using semi-structured format) to assess the participants' perspectives on the acceptability and feasibility of participating in the on-site post-intervention interview	Interview (anticipated duration of 60 minutes) will be conducted after week ten of intervention implementation (week 11)