NCT02911194

Brief Summary

Under double-blind, placebo-controlled, cross-over conditions, the short-term effects of use of A1 beta casein free milk (a2 milk) and milk containing A1 beta casein will be compared in a sample of pre-pubescent boys diagnosed with an autism spectrum disorder (ASD) with concurrent features of attention-deficit hyperactivity disorder (ADHD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

July 22, 2016

Last Update Submit

September 4, 2018

Conditions

AutismAttention Deficit Hyperactivity DisorderAutism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

  • Change in Childhood Autism Rating Scale (CARS2-HF) Value during intervention

    Difference in CARS raw scores and severity group between baseline and 4 weeks and 8 weeks.

    Baseline to Week 4 to Week 8

  • Change in Conners' Rating Scale - Revised (L) value during intervention.

    Difference in Conners' raw scores and totalled scores between baseline and 4 weeks and 8 weeks

    Baseline to Week 4 to Week 8

Secondary Outcomes (4)

  • Amino acid analysis of urine samples by mass spectroscopy.

    Baseline to Week 4 to Week 8

  • Metabolomic analysis of blood spot samples by mass spectroscopy.

    Baseline to Week 4 to Week 8

  • Changes to the gut microbiome profile.

    Baseline to Week 4 to Week 8

  • Changes to stool appearance measured using the Bristol Stool Chart.

    Baseline to Week 4 to Week 8

Study Arms (2)

Treatment

EXPERIMENTAL

a2 milk intervention period

Dietary Supplement: a2 milk

Control

PLACEBO COMPARATOR

a1 containing milk (normal) intervention period

Dietary Supplement: a1 containing milk

Interventions

a2 milkDIETARY_SUPPLEMENT

replace all milk with a2 milk

Treatment
a1 containing milkDIETARY_SUPPLEMENT

use a1 containing milk

Control

Eligibility Criteria

Age5 Years - 10 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of autism spectrum disorder (autism, Asperger syndrome, Autism Spectrum Disorder)
  • Diagnosis or fulfilling the diagnostic criteria for / presenting with the symptoms of attention-deficit hyperactivity disorder (ADHD)
  • Regular milk drinker
  • Functional use of spoken language (for ability to self-report)
  • Access to internet connection (WiFi)

You may not qualify if:

  • Undergoing current medical treatment (and an inpatient at a state hospital)
  • Current or past 3 month use of a gluten- and/or casein-free diet
  • Co-morbid diagnoses of Fragile-X syndrome, epilepsy or tuberous sclerosis
  • Indications or diagnosis of cows milk protein allergy (IgE)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ESPA Research

Sunderland, Tyne and Wear, United Kingdom

Location

Related Publications (7)

  • Whiteley P. Nutritional management of (some) autism: a case for gluten- and casein-free diets? Proc Nutr Soc. 2015 Aug;74(3):202-7. doi: 10.1017/S0029665114001475. Epub 2014 Oct 14.

    PMID: 25311313BACKGROUND

  • Pedersen L, Parlar S, Kvist K, Whiteley P, Shattock P. Data mining the ScanBrit study of a gluten- and casein-free dietary intervention for children with autism spectrum disorders: behavioural and psychometric measures of dietary response. Nutr Neurosci. 2014 Sep;17(5):207-13. doi: 10.1179/1476830513Y.0000000082. Epub 2013 Nov 26.

    PMID: 24075141BACKGROUND

  • Whiteley P, Shattock P, Knivsberg AM, Seim A, Reichelt KL, Todd L, Carr K, Hooper M. Gluten- and casein-free dietary intervention for autism spectrum conditions. Front Hum Neurosci. 2013 Jan 4;6:344. doi: 10.3389/fnhum.2012.00344. eCollection 2012.

    PMID: 23316152BACKGROUND

  • Whiteley P, Haracopos D, Knivsberg AM, Reichelt KL, Parlar S, Jacobsen J, Seim A, Pedersen L, Schondel M, Shattock P. The ScanBrit randomised, controlled, single-blind study of a gluten- and casein-free dietary intervention for children with autism spectrum disorders. Nutr Neurosci. 2010 Apr;13(2):87-100. doi: 10.1179/147683010X12611460763922.

    PMID: 20406576BACKGROUND

  • Jianqin S, Leiming X, Lu X, Yelland GW, Ni J, Clarke AJ. Effects of milk containing only A2 beta casein versus milk containing both A1 and A2 beta casein proteins on gastrointestinal physiology, symptoms of discomfort, and cognitive behavior of people with self-reported intolerance to traditional cows' milk. Nutr J. 2016 Apr 2;15:35. doi: 10.1186/s12937-016-0147-z.

    PMID: 27039383BACKGROUND

  • Ho S, Woodford K, Kukuljan S, Pal S. Comparative effects of A1 versus A2 beta-casein on gastrointestinal measures: a blinded randomised cross-over pilot study. Eur J Clin Nutr. 2014 Sep;68(9):994-1000. doi: 10.1038/ejcn.2014.127. Epub 2014 Jul 2.

    PMID: 24986816BACKGROUND

  • Trivedi MS, Shah JS, Al-Mughairy S, Hodgson NW, Simms B, Trooskens GA, Van Criekinge W, Deth RC. Food-derived opioid peptides inhibit cysteine uptake with redox and epigenetic consequences. J Nutr Biochem. 2014 Oct;25(10):1011-8. doi: 10.1016/j.jnutbio.2014.05.004. Epub 2014 Jun 6.

    PMID: 25018147BACKGROUND

Related Links

MeSH Terms

Conditions

Autistic DisorderAttention Deficit Disorder with HyperactivityAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersAttention Deficit and Disruptive Behavior Disorders

Study Officials

  • John K Lodge, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 22, 2016

First Posted

September 22, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will share

Group data will be available upon request

Locations

GB(1)