- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Eleanor F Jackson
- Numer telefonu: +447908873415
- E-mail: efjackson1@sheffield.ac.uk
Kopia zapasowa kontaktu do badania
- Nazwa: Paul G Overton, Professor
- E-mail: p.g.overton@sheffield.ac.uk
Lokalizacje studiów
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-
South Yorkshire
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Sheffield, South Yorkshire, Zjednoczone Królestwo, S10 2TN
- Rekrutacyjny
- University of Sheffield
-
Kontakt:
- Eleanor Jackson
- Numer telefonu: +447908873415
- E-mail: efjackson1@sheffield.ac.uk
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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).
Inne nazwy:
|
|
Eksperymentalny: 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).
Inne nazwy:
|
|
Komparator 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
|
|
Aktywny 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).
Inne nazwy:
|
|
Aktywny 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).
Inne nazwy:
|
|
Komparator 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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in distractibility - microsaccades
Ramy czasowe: pre and 90 minutes post administration
|
Frequency of microsaccades in a simple fixation task
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pre and 90 minutes post administration
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Change in distractibility - reaction time
Ramy czasowe: pre and 90 minutes post administration
|
Measurement of reaction time on a visual search task with varying auditory stimuli.
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pre and 90 minutes post administration
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Change in distractibility- fixations
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Zaburzenia neurorozwojowe
- Deficyt uwagi i destrukcyjne zaburzenia zachowania
- Zespół deficytu uwagi z nadpobudliwością
- Aminokwasy, peptydy i białka
- Żywność
- Dieta, żywność i odżywianie
- Zjawiska fizjologiczne
- Jedzenie i napoje
- Aminokwasy
- Aminokwasy, aromatyczne
- Aminokwasy, cykliczne
- Tryptofan
- 5-hydroksytryptofan
- Suplementy diety
Inne numery identyfikacyjne badania
- 070759
- 10.17605/OSF.IO/7GWMC (Inny identyfikator: OSF)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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