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The Effect of 5-hydroxytryptophan on ADHD Traits and Eye Movements

18 de agosto de 2026 atualizado por: Eleanor Jackson, University of Sheffield

The Effect of 5-hydroxytryptophan on Microsaccades and Distractibility in Individual With High Levels of ADHD Traits: a Randomised, Double-blind Trial

The aim of this project is to look at the impact of 5-Hydroxytryptophan (5-HTP) on distractibility. 5-HTP is the precursor to the neurotransmitter serotonin and is a chemical that the body produces naturally. There is evidence that distractibility is associated with a decreased level of serotonin. This research aims to see if giving people 5-HTP will alter their distractibility, which will form part of an initial assessment as to whether 5-HTP could be used to support people with attention problems. The study involves completing a short survey about mental health and behaviours, and if eligible, participation in an in-person study at the University of Sheffield. The in-person session involves completing some cognitive tasks to look at eye movement, taking 5-HTP or a sugar tablet with no active ingredients, and then completing the tasks again after a 90-minute wait.

Visão geral do estudo

Descrição detalhada

The overarching aim of this project is to assess the efficacy and suitability of 5-hydroxytryptophan, a nutritional supplement and precursor to serotonin, as a potential therapeutic for ADHD traits. 5-hydroxytryptophan is a metabolic product produced in the body following consumption of foods with high levels of the amino acid tryptophan, found in soy products, egg whites, and other high-protein foods. Both tryptophan and 5-hydroxytryptophan are metabolic precursors to serotonin, a neurotransmitter that is essential for the regulation of sleep, emotional state, aggression, and, most relevantly, the regulation of attention. Serotonin levels have been shown to be significantly reduced in individuals with ADHD, and some theories suggest that this is linked to reduced serotonin synthesis; of particular interest is the step where tryptophan is converted to 5-hydroxytryptophan, both the rate-limiting step of serotonin synthesis and a possible genetic locus of change in ADHD. 5-hydroxytryptophan can be readily obtained from health shops as a supplement, derived from the seeds of the edible plant Griffonia Simplicifolia, which has been long used in traditional medicine, and its ability to be absorbed easily from the intestinal tract and skip the rate-limiting step of synthesis makes it an attractive possible therapeutic. Pre-clinical work where 5-hydroxytryptophan was administered to Rhesus Macaques found that the supplement increased attention in animals with a low baseline level of attention, highlighting a possible benefit to supplementation.

Although theoretically promising, our previous empirical study failed to find any effect of 5-hydroxytryptophan supplementation on individuals with high or low levels of ADHD-like traits. The study had several limitations, a significant one being that tasks that were meant to assess distractibility did not show a distractor effect, and did not provide discrimination between high and low ADHD trait groups. As such, we aim to attempt to re-assess the impact of 5-hydroxytryptophan with tasks that are better established as being ADHD-sensitive, particularly those of microsaccades and ocular motor behaviour, alongside a distractor task established in a previous pilot. Our primary study design also only considered one dose of 5-hydroxytryptophan, whereas in this iteration, we will use two different doses of 5-hydroxytryptophan to better establish a dose-response effect. Finally, given the heterogeneity of ADHD-traits and comorbidity with other neurodevelopmental and psychiatric conditions, we intend to better characterise the affective state of the cohort in order to better control for confounds and co-morbidity in the final data set.

The proposed study will be conducted in two parts:

A pre-screen survey to determine participant eligibility:

AIM = to assess the eligibility and ADHD traits of potential participants.

In-person participation in a randomised, double-blind trial at the University of Sheffield, where participants will ingest either intervention or placebo and complete cognitive tasks pre- and post-administration.

AIM = to determine the impact of 5-hydroxytryptophan supplementation on cognitive and oculomotor behaviour of individuals with high and low levels of ADHD traits.

Tipo de estudo

Intervencional

Inscrição (Estimado)

150

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

    • South Yorkshire
      • Sheffield, South Yorkshire, Reino Unido, S10 2TN
        • Recrutamento
        • University of Sheffield
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • 18-65 years of age
  • Normal or corrected to normal vision with contact lenses.
  • Score of <9 or >14 on the ASRS v5 (assessed in pre screen questionnaire)

Exclusion Criteria:

  • Current use of psychostimulant medication or medication for the treatment of ADHD
  • Current use of medications known to impact the serotonergic system (e.g., SSRIs).
  • Smoking or vaping
  • Pregnancy
  • Breast feeding
  • Lactose intolerance
  • Veganism
  • Dyslexia

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: High ADHD traits - 200mg 5-HTP
Participants who have reported high levels of ADHD traits, and have been randomly allocated to the group receiving 200 mg 5-HTP, administered orally in tablet form.
200mg 5-HTP delivered in two tablets. Tablets obtained from Nature's Best supplements. Each tablet contains 3982mg of Griffonia seed extract, providing 100mg of 5-HTP. The tablets consist of calcium carbonate, griffonia seed extract, Anti-caking Agents (Silicon Dioxide, Stearic Acid, & Magnesium Stearate) and Tablet Coating (Hydroxypropyl Methylcellulose, Glycerol).
Outros nomes:
  • 5-HTP
Experimental: High ADHD traits - 300mg 5-HTP
Participants who have reported high levels of ADHD traits, and have been randomly allocated to the group receiving 300 mg 5-HTP, administered orally in tablet form.
300mg 5-HTP delivered in three tablets. Tablets obtained from Nature's Best supplements. Each tablet contains 3982mg of Griffonia seed extract, providing 100mg of 5-HTP. The tablets consist of calcium carbonate, griffonia seed extract, Anti-caking Agents (Silicon Dioxide, Stearic Acid, & Magnesium Stearate) and Tablet Coating (Hydroxypropyl Methylcellulose, Glycerol).
Outros nomes:
  • 5-HTP
Comparador de Placebo: High ADHD traits - Placebo
Participants who have reported high levels of ADHD traits, and have been randomly allocated to the group receiving placebo. Placebo consists of 2 sucrose-lactose tablets, administered orally.
Unmedicated lactose-sucrose tablets provided by Ainsworth's homoeopathic remedies
Comparador Ativo: Low ADHD traits - 200mg 5-HTP
Participants who have reported low levels of ADHD traits, and have been randomly allocated to the group receiving 200 mg 5-HTP, administered orally in tablet form.
200mg 5-HTP delivered in two tablets. Tablets obtained from Nature's Best supplements. Each tablet contains 3982mg of Griffonia seed extract, providing 100mg of 5-HTP. The tablets consist of calcium carbonate, griffonia seed extract, Anti-caking Agents (Silicon Dioxide, Stearic Acid, & Magnesium Stearate) and Tablet Coating (Hydroxypropyl Methylcellulose, Glycerol).
Outros nomes:
  • 5-HTP
Comparador Ativo: Low ADHD traits - 300mg 5-HTP
Participants who have reported low levels of ADHD traits, and have been randomly allocated to the group receiving 300 mg 5-HTP, administered orally in tablet form.
300mg 5-HTP delivered in three tablets. Tablets obtained from Nature's Best supplements. Each tablet contains 3982mg of Griffonia seed extract, providing 100mg of 5-HTP. The tablets consist of calcium carbonate, griffonia seed extract, Anti-caking Agents (Silicon Dioxide, Stearic Acid, & Magnesium Stearate) and Tablet Coating (Hydroxypropyl Methylcellulose, Glycerol).
Outros nomes:
  • 5-HTP
Comparador de Placebo: Low ADHD traits - placebo
Participants who have reported low levels of ADHD traits, and have been randomly allocated to the group receiving placebo. Placebo consists of 2 sucrose-lactose tablets, administered orally.
Unmedicated lactose-sucrose tablets provided by Ainsworth's homoeopathic remedies

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in distractibility - microsaccades
Prazo: pre and 90 minutes post administration
Frequency of microsaccades in a simple fixation task
pre and 90 minutes post administration
Change in distractibility - reaction time
Prazo: pre and 90 minutes post administration
Measurement of reaction time on a visual search task with varying auditory stimuli.
pre and 90 minutes post administration
Change in distractibility- fixations
Prazo: pre and 90 minute post administration
Number of fixations on distractor letters in a visual search task with varying auditory stimuli.
pre and 90 minute post administration

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

25 de novembro de 2025

Conclusão Primária (Estimado)

1 de fevereiro de 2027

Conclusão do estudo (Estimado)

1 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

12 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de agosto de 2026

Primeira postagem (Real)

20 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

IPD regarding group allocation, ASRS scores, and measures on microsaccades and visual search tasks will be shared following completion of the study.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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