Curcumin and Retinal Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Low curcumin group, High curcumin group.
- Кому может быть актуально
- Состояния в реестре: Bioavailability, Gut Microbiome, Safety. Базовые параметры: 40 лет — 89 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Curcumin and Retinal Amyloid-beta Pilot Study
Обзор
To test how two weeks of curcumin supplementation would cross the blood brain barrier (BBB) and attach to amyloid beta proteins, to assess the feasibility (safety and bioavailability), and to explore the resulting abundance/composition of gut microbiota.
Подробное описание
Alzheimer's disease (AD) leads to progressive cognitive decline. Increased amyloid beta (Aβ) burden and Aβ deposits have been shown in the AD retina. Aβ accumulation inside retinal pericytes in AD and pericyte degeneration in the retina mirror prominent features of brain AD pathology. Curcumin, a derivative of turmeric, has a high affinity for amyloid beta. Thus, curcumin would bind to amyloid beta plaques and emit a strong fluorescent signal, suggesting it can be a powerful diagnostic tool for AD. Emerging evidence has shown the connection between the brain and GI tract (gut microbiome), and its potential implications for both metabolic and neurologic diseases including AD. This pilot study is to test how two weeks of curcumin supplementation would cross the blood brain barrier and attach to amyloid beta proteins and to explore the resulting abundance/composition of gut microbiota. The investigators plan to recruit subjects through direct person-to-person solicitation in the Ophthalmology clinics, health fairs, community events, flyers, non-solicited email system, campus announcements, Clinical Research Institute Volunteer Database website, local radio, newspapers, senior newsletters, and TV scripts. The Clinical Research Institute Volunteer database will also be queried and potential subjects contacted as requested in their form. The investigators plan to enroll approximately 100-150 patients to obtain 30-40 qualified subjects at the start of the study. After screening, qualified participants will be randomly assigned to a low curcumin group or high curcumin group. Thus, this pilot study would focus on characterizing the distribution, manifestation, and prevalence of curcumin-loaded retinal Aβ deposits in study subjects with existing Aβ plaque (primary outcome). In addition, this study will assess safety, bioavailability, and fecal microbiome composition (secondary outcome). All outcomes will be assessed at baseline and after 2 weeks of intervention. Data will be analyzed statistically.
Вмешательства
- Препарат Low curcumin group
One curcumin capsule (250 mg curcumin) after each meal, 3 times a day for 2 weeks. - Препарат High curcumin group
One curcumin capsule (500 mg curcumin) after each meal, 3 times a day for 2 weeks.
Первичные конечные точки
- Retinal imaging- amyloid fluorescent intensity [Срок оценки: Baseline]
- Retinal imaging-amyloid fluorescent deposit number [Срок оценки: Baseline]
- Retinal imaging-amyloid fluorescent location [Срок оценки: Baseline]
- Retinal imaging-amyloid fluorescent intensity [Срок оценки: After 2 weeks]
- Retinal imaging-amyloid fluorescent deposit number [Срок оценки: After 2 weeks]
- Retinal imaging-amyloid fluorescent location [Срок оценки: After 2 weeks]
Вторичные конечные точки (12)
- Bioavailability- curcumin concentrations in plasma [Срок оценки: Baseline]
- Bioavailability-curcumin concentrations in red blood cells [Срок оценки: Baseline]
- Bioavailability-curcumin concentrations in plasma [Срок оценки: After 2 weeks]
- Bioavailability-curcumin concentrations in red blood cells [Срок оценки: After 2 weeks]
- Liver function-serum AST [Срок оценки: Baseline]
- Liver function-serum ALT [Срок оценки: Baseline]
- Kidney function-serum BUN [Срок оценки: Baseline]
- Liver function-serum ALT [Срок оценки: After 2 weeks]
- Kidney function-serum BUN [Срок оценки: After 2 weeks]
- Gut microbiome-abundance [Срок оценки: Baseline]
- Gut microbiome-composition [Срок оценки: Baseline]
- Gut microbiome-abundance [Срок оценки: After 2 weeks]
Критерии участия
Inclusion:
- Both male and female, age 40 - 89 years.
- Diagnosed with Aβ deposits in retina (peripheral superior quadrants)--to be confirmed after consent obtained. If there is documentation the potential participant has been diagnosed with Aβ deposits in retina within 6 months before the consent session, we will use this diagnosis/documentation for eligibility criteria. Otherwise, the ophthalmic exam will be repeated after consent is obtained for the study.
- No pre-existing liver or kidney diseases by self-report.
Exclusion:
- Patients with ocular diseases (macular degeneration, severe diabetes retinopathy)
- Had used systemic antibiotics within 1 month prior to the start of the study intervention
- Had taken any turmeric or curcumin products within 2 weeks prior to the start of the study intervention
- Had a known allergy to black pepper
- Women that are pregnant or breastfeeding
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Другое
Центры проведения
США · 1 центр
- Texas Tech University Health Sciences Center — Lubbock
Идентификаторы
NCT: NCT05774704 · Curcumin-Retinal Pilot Study