- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Eleanor F Jackson
- Номер телефона: +447908873415
- Электронная почта: efjackson1@sheffield.ac.uk
Учебное резервное копирование контактов
- Имя: Paul G Overton, Professor
- Электронная почта: p.g.overton@sheffield.ac.uk
Места учебы
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South Yorkshire
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Sheffield, South Yorkshire, Соединенное Королевство, S10 2TN
- Рекрутинг
- University of Sheffield
-
Контакт:
- Eleanor Jackson
- Номер телефона: +447908873415
- Электронная почта: efjackson1@sheffield.ac.uk
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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).
Другие имена:
|
|
Экспериментальный: 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).
Другие имена:
|
|
Плацебо Компаратор: 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
|
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Активный компаратор: 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).
Другие имена:
|
|
Активный компаратор: 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).
Другие имена:
|
|
Плацебо Компаратор: 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
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in distractibility - microsaccades
Временное ограничение: 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
Временное ограничение: pre and 90 minutes post administration
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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
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Психические расстройства
- Нарушения развития нервной системы
- Дефицит внимания и расстройства разрушительного поведения
- Синдром дефицита внимания с гиперактивностью
- Аминокислоты, пептиды и белки
- Еда
- Диета, еда и питание
- Физиологические явления
- Еда и напитки
- Аминокислоты
- Аминокислоты, ароматные
- Аминокислоты, циклические
- Триптофан
- 5-гидрокситриптофан
- Диетические добавки
Другие идентификационные номера исследования
- 070759
- 10.17605/OSF.IO/7GWMC (Другой идентификатор: OSF)
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .