- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Eleanor F Jackson
- Telefonnummer: +447908873415
- E-mail: efjackson1@sheffield.ac.uk
Undersøgelse Kontakt Backup
- Navn: Paul G Overton, Professor
- E-mail: p.g.overton@sheffield.ac.uk
Studiesteder
-
-
South Yorkshire
-
Sheffield, South Yorkshire, Det Forenede Kongerige, S10 2TN
- Rekruttering
- University of Sheffield
-
Kontakt:
- Eleanor Jackson
- Telefonnummer: +447908873415
- E-mail: efjackson1@sheffield.ac.uk
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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).
Andre navne:
|
|
Eksperimentel: 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).
Andre navne:
|
|
Placebo komparator: 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
|
|
Aktiv komparator: 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).
Andre navne:
|
|
Aktiv komparator: 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).
Andre navne:
|
|
Placebo komparator: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in distractibility - microsaccades
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Neuroudviklingsforstyrrelser
- Opmærksomhedsunderskud og forstyrrende adfærdsforstyrrelser
- Attention Deficit Disorder med hyperaktivitet
- Aminosyrer, peptider og proteiner
- Mad
- Diæt, mad og ernæring
- Fysiologiske fænomener
- Mad og drikkevarer
- Aminosyrer
- Aminosyrer, aromatisk
- Aminosyrer, cykliske
- Tryptophan
- 5-hydroxytryptophan
- Kosttilskud
Andre undersøgelses-id-numre
- 070759
- 10.17605/OSF.IO/7GWMC (Anden identifikator: OSF)
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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