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Идёт набор NCT06489873

Lutein, Zeaxathin, and Fish Oil Supplementation

Без фазы С лечением Cognitive Performance Age-Related Macular Degeneration Bone Loss

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: Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF), Placebo Comparator.
Кому может быть актуально
Состояния в реестре: Cognitive Performance, Age-Related Macular Degeneration, Bone Loss. Базовые параметры: 18 лет — 45 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
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Официальное название

The Role of Lutein, Zeaxanthin, and Fish Oil on Cognitive Function and Bone Health in Healthy Adults

Обзор

The goal of this clinical trial is to learn the impact of lutein, zeaxanthin, and fish oil (LZF) supplementation in healthy adults. The main question it aims to answer is: Will supplementation with LZF improve macular pigment optical density (MPOD), cognitive performance and bone mass compared to controls after six months? Subjects with an MPOD \<.43 will significantly improve MPOD after 6-months of LZF supplementation. Consuming a LZFO supplement for 6-months will improve visual cognitive performance. Consuming a LZFO supplement for 6-months will improve bone density. Participants will be asked to take either a LZF supplement or placebo daily for 6 months.

Подробное описание

Macular degeneration, cognitive decline, and osteoporosis often occur with aging. Lutein, zeaxanthin, and fish oil (LZF) have been shown to have improvements in these areas. This 6-month double-blind randomized controlled trial will study the impact of LZF on cognitive performance, macular pigment optical density (MPOD), and bone health in healthy adults ages 18-45 with a MPOD \<.43. We seek to create a precision nutrition model reducing macular degeneration, cognition, and bone health that includes non-invasive screening for high-risk carotenoid deficiencies (MPOD, dietary intake) and individual response to LZF supplementation.

Healthy adults ages 18-45 years with MPOD \<.43 will be randomly assigned to take a LZF supplement with 7 mg lutein, 14 mg zeaxanthin, and 245 mg fish oil or a placebo daily for six months. They will have baseline and ending measures of fasting blood draw, MPOD, bone health using a DXA, and visual cognitive performance using Neurotracker software.

Вмешательства

  • Пищевая добавка Active Comparator (Lutein, zeaxanthin, and fish oil supplement (LZF)
    Each participant will be assigned to t a LZF supplement daily for six months
  • Пищевая добавка Placebo Comparator
    Each participant will be assigned to take a placebo supplement daily for six months

Первичные конечные точки

  • Macular Pigment Optical Density (MPOD) [Срок оценки: MPOD will be measured at baseline, 3 months after the start of the study, and at the final 6 month visit, which will be the completion of the study.]
  • Cognitive Performance [Срок оценки: Cognitive performance will be measured at the three baseline appointments, the three appointments at 3 months, and the 3 appointments at 6 months after the start of the study, which will be the completion of the study]
  • Bone Density [Срок оценки: Bone density will be measured at baseline and at the final 6 month visit, which will be the completion of the study.]
Вторичные конечные точки (1)
  • Lutein and Zeaxanthin Serum Levels [Срок оценки: Serum lutein and zeaxanthin will be measured at baseline and at the final 6 month visit, which will be the completion of the study.]

Критерии участия

Критерии включения

  • <.43 MPOD, a self-reported best-corrected vision of 20/40 or better in each eye, a BMI range of 18.5-30, and meets the inclusion criteria on the preliminary participant questionnaire.

Критерии исключения

  • allergic to lutein, zeaxanthin, or fish oil, taking supplements with >6 mg lutein and/or >2 mg zeaxanthin for more than two months before study starts, MPOD between >.43, self-reported condition of vertigo, diabetic retinopathy, retinitis pigmentosa, optic neuropathy, retinal vascular occlusions, strabismus, autoimmune disorders related to visual health, currently pregnant or trying to become pregnant, history of concussion, vegan (due to gelatin in the placebo), and/or taking neuroactive medications, such as Ritalin, Adderall, antidepressants, etc.

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
  • Gilchrist Building — College Station

Идентификаторы

NCT: NCT06489873 · 2024-0035

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗