- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07777328
The Effect of 5-hydroxytryptophan on ADHD Traits and Eye Movements
The Effect of 5-hydroxytryptophan on Microsaccades and Distractibility in Individual With High Levels of ADHD Traits: a Randomised, Double-blind Trial
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Eleanor F Jackson
- Numéro de téléphone: +447908873415
- E-mail: efjackson1@sheffield.ac.uk
Sauvegarde des contacts de l'étude
- Nom: Paul G Overton, Professor
- E-mail: p.g.overton@sheffield.ac.uk
Lieux d'étude
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South Yorkshire
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Sheffield, South Yorkshire, Royaume-Uni, S10 2TN
- Recrutement
- University of Sheffield
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Contact:
- Eleanor Jackson
- Numéro de téléphone: +447908873415
- E-mail: efjackson1@sheffield.ac.uk
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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).
Autres noms:
|
|
Expérimental: 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).
Autres noms:
|
|
Comparateur 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
|
|
Comparateur actif: 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).
Autres noms:
|
|
Comparateur actif: 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).
Autres noms:
|
|
Comparateur 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in distractibility - microsaccades
Délai: pre and 90 minutes post administration
|
Frequency of microsaccades in a simple fixation task
|
pre and 90 minutes post administration
|
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Change in distractibility - reaction time
Délai: 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
|
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Change in distractibility- fixations
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Weinberg-Wolf H, Fagan NA, Anderson GM, Tringides M, Dal Monte O, Chang SWC. The effects of 5-hydroxytryptophan on attention and central serotonin neurochemistry in the rhesus macaque. Neuropsychopharmacology. 2018 Jun;43(7):1589-1598. doi: 10.1038/s41386-017-0003-7. Epub 2018 Jan 30.
- Vigliante I, Mannino G, Maffei ME. Chemical Characterization and DNA Fingerprinting of Griffonia simplicifolia Baill. Molecules. 2019 Mar 15;24(6):1032. doi: 10.3390/molecules24061032.
- Panagiotidi M, Paul O, Tom S. Increased microsaccade rate in individuals with ADHD traits. J Eye Mov Res. 2017 Mar 4;10(1):10.16910/jemr.10.1.6. doi: 10.16910/jemr.10.1.6.
- Turner EH, Loftis JM, Blackwell AD. Serotonin a la carte: supplementation with the serotonin precursor 5-hydroxytryptophan. Pharmacol Ther. 2006 Mar;109(3):325-38. doi: 10.1016/j.pharmthera.2005.06.004. Epub 2005 Jul 14.
- Lovejoy LP, Krauzlis RJ. Inactivation of primate superior colliculus impairs covert selection of signals for perceptual judgments. Nat Neurosci. 2010 Feb;13(2):261-6. doi: 10.1038/nn.2470. Epub 2009 Dec 20.
- Lindseth G, Helland B, Caspers J. The effects of dietary tryptophan on affective disorders. Arch Psychiatr Nurs. 2015 Apr;29(2):102-7. doi: 10.1016/j.apnu.2014.11.008. Epub 2014 Dec 9.
- Jackson E, Riley T, Overton PG. The effect of 5-hydroxytryptophan, a serotonin precursor, on adults with high levels of Attention Deficit Hyperactivity Disorder traits: A randomised, controlled trial. PLoS One. 2026 May 20;21(5):e0349512. doi: 10.1371/journal.pone.0349512. eCollection 2026.
- Jackson EF, Riley TB, Overton PG. Serotonin dysfunction in ADHD. J Neurodev Disord. 2025 Apr 22;17(1):20. doi: 10.1186/s11689-025-09610-y.
- Birdsall TC. 5-Hydroxytryptophan: a clinically-effective serotonin precursor. Altern Med Rev. 1998 Aug;3(4):271-80.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles neurodéveloppementaux
- Déficit de l'attention et troubles du comportement perturbateur
- Trouble déficitaire de l'attention avec hyperactivité
- Acides aminés, peptides et protéines
- Nourriture
- Régime, nourriture et nutrition
- Phénomènes physiologiques
- Nourriture et boissons
- Acides aminés
- Acides aminés, aromatique
- Acides aminés, cyclique
- Tryptophane
- 5-hydroxytryptophane
- Suppléments alimentaires
Autres numéros d'identification d'étude
- 070759
- 10.17605/OSF.IO/7GWMC (Autre identifiant: OSF)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
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