Cognitive Vitality Pilot Study

Официальное название

Effects of Dietary Supplement Intervention on Cognitive Function and Psychological Well-Being

Обзор

This study's purpose is to evaluate the effects of a dietary supplement on cognitive function and psychological well-being in community-dwelling older adults aged 55+. The study involves taking a commercially available dietary supplement daily for 45 days. A 45-minute assessment will be conducted at the beginning and again at the end of the study.

Подробное описание

The primary aim of this randomized, single-site pilot study is to evaluate the effects of the oral liquid dietary supplement Axolt (https://axoltbrain.com) on cognitive function in adults aged 55 and older without cognitive impairment, compared to a control group taking a commercially available, hydration powdered drink flavoring, Bolero (https://bolerousa.net) daily for 45 days. The secondary aim is to assess changes in mood and psychological well-being with supplement intake. The study will use validated, low-risk cognitive measures at baseline and at the end of the study to measure change over time. 20 individuals age 55 years and older will be recruited. Sample size for enrollment: (n =8) for the active group and (n=8) in the control group (16 total), accounting for an anticipated 20% drop out rate.

Вмешательства

• Пищевая добавка Axolt Brain Supplement
  https://axoltbrain.com/ Axolt is a brain health supplement. It includes native ingredients, formulated to help the brain perform at its best.
• Пищевая добавка Bolero - Flavored Drink Placebo
  The control group will be asked to consume 1 packet of Bolero flavored water mix hydration enhancement also in about 16 oz of water once a day for 45 days.

Первичные конечные точки

• Digit Span Forward [Срок оценки: From enrollment to the end of treatment at 45 days.]
• RAVLT Learning [Срок оценки: From enrollment to the end of treatment at 45 days.]
• Digit Span Backward [Срок оценки: From enrollment to the end of treatment at 45 days.]
• Symbol Digit Modalities Test (SDMT) [Срок оценки: From enrollment to the end of treatment at 45 days.]
• RAVLT Recall [Срок оценки: From enrollment to the end of treatment at 45 days.]
• Brain Fog Questionnaire [Срок оценки: From enrollment to the end of treatment at 45 days.]
• PHQ-9 [Срок оценки: From enrollment to the end of treatment at 45 days.]
• GAD-7 [Срок оценки: From enrollment to the end of treatment at 45 days.]

Критерии участия

Критерии включения

• Adults aged 55 years and older
• Live independently,
• Self-report as healthy
• Adequate vision
• Fluent in English
• No history of mild cognitive impairment
• Currently not taking dietary supplements with the same active ingredients in Axolt or naturally flavored water
• A Montreal Cognitive Assessment \[12\] (MOCA) score ≥ 24
• Able to provide written informed consent, and medical clearance to participate.

Критерии исключения

• Previous participation in a cognitive dietary supplement study in the last 12 months
• A score of < 24 on the Montreal Cognitive Assessment (MoCA) as a potential risk for obtaining informed consent
• History of seizures
• Epilepsy
• Parkinson's disease
• History of severe head trauma
• Uncontrolled hypertension
• On psychoactive medications
• Substance abuse
• Unwilling or unable to discontinue current dietary supplements with similar ingredients
• Planned surgery during the study period
• Medications known to interact with active ingredients with Axolt
• Minors and prisoners will be excluded.

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

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Community — West Palm Beach

Идентификаторы

NCT: NCT07208279 · STUDY00022585

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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