The Feasibility of a Dietary Intervention in Children With ADHD

NCT ID: NCT03737877

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-14
• Study Completion Date: 2019-07-31

Brief Summary

The aim is to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with ADHD.

Detailed Description

Children with Attention Deficit Hyperactivity Disorder (ADHD) can suffer debilitating symptoms, including problematic behaviour and sleep. Research suggests dietary manipulations may be a helpful treatment option for children with ADHD, although the most effective are highly restrictive, with little known about why they might work. Optimising gut bacteria in individuals with ADHD may help alleviate some of the symptoms of this condition via the gut-brain-axis and would provide a plausible mechanism by which dietary interventions operate. We propose to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with ADHD.

Conditions

ADHD; Diet Modification

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Diet modification

Group Type: EXPERIMENTAL

Diet modification

Intervention Type: OTHER

The parents will have four group sessions with a nutritional therapist, where in depth advice and information about the diet will be provided. Ongoing support will also be provided throughout the study by use of a closed Facebook or WhatsApp group (whichever the parents choose as most appropriate). The diet is based on five main principles:

• Eat at least seven portions of different varieties of fruit and vegetables each day.
• Have a 12 hour overnight break from food (water only during this time).
• Drink a Kefir drink each day - provided free of charge.
• Eat a microbiome friendly, protein rich, breakfast from our menu.
• Reduce sugar and artificial sweeteners.

Interventions

Diet modification

The parents will have four group sessions with a nutritional therapist, where in depth advice and information about the diet will be provided. Ongoing support will also be provided throughout the study by use of a closed Facebook or WhatsApp group (whichever the parents choose as most appropriate). The diet is based on five main principles:

• Eat at least seven portions of different varieties of fruit and vegetables each day.
• Have a 12 hour overnight break from food (water only during this time).
• Drink a Kefir drink each day - provided free of charge.
• Eat a microbiome friendly, protein rich, breakfast from our menu.
• Reduce sugar and artificial sweeteners.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Parent-reported diagnosis of ADHD.

2. Children aged between 8 years - 13 years 11 months at onset of study.

3. Children not taking ADHD medication (such as methylphenidate) at the time of the study.

4. Parental permission to attend three group sessions and for themselves and their child to complete the requisite assessments.

5. Both males and females are eligible to take part.

6. Children with a co-occurring diagnosis will be accepted onto the trial.

7. Children with food allergies/sensitivities/coeliac disease will be accepted onto the trial.

Exclusion Criteria

1. Children undergoing a current course of behavioural therapy.

2. Children currently on ADHD medication (such as methylphenidate).

3. Children who have taken antibiotics in the past 3 months

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Goldsmiths, University of London

OTHER

Sponsor Role: collaborator

St Mary's University College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St Mary's University

London, , United Kingdom

Countries

United Kingdom

References

Lawrence K, Myrissa K, Toribio-Mateas M, Minini L, Gregory AM. Trialling a microbiome-targeted dietary intervention in children with ADHD-the rationale and a non-randomised feasibility study. Pilot Feasibility Stud. 2022 May 23;8(1):108. doi: 10.1186/s40814-022-01058-4.

Reference Type: DERIVED

PMID: 35606889 (View on PubMed)

Other Identifiers

SMEC_2017-18_132

Identifier Type: -

Identifier Source: org_study_id