Effect of a Specially Formulated Dietary Supplement With Pyrroloquinoline Quinone, γ-aminobutyric Acid, Caffeine and B-vitamins on Cognitive Function in Healthy Postmenopausal Women: a Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Neurocognition Index (NCI)
研究概览
简要总结
Various food supplements have been shown to improve cognitive function. However, there is limited data on the impact of these supplements on postmenopausal women. Millions of women experience difficulty with concentration, and memory lapses during menopause. Research shows that up to 60% of women report cognitive changes related to menopause, severely impacting their quality of life and professional performance. Women are significantly more likely to develop dementia and other cognitive dysfunction. The specially formulated Cortexium with four key ingredients aims to support cognitive function in women:
- PQQ (Pyrroloquinoline Quinone) is a redox coenzyme with high antioxidant potential and is considered to affect the brain function by increasing mitochondrial production and activation, nerve cell protection, and enhanced production of nerve growth factor.
- GABA (gamma-aminobutyric acid) is an important neurotransmitter that helps induce calm and relaxation in the brain. Its positive effects include reducing stress and anxiety, which promotes mental clarity and concentration, thus enhancing mental performance. Additionally, it can help combat fatigue by supporting restful sleep, which, in the long term, boosts brain function efficiency.
- B-VITAMINS (B1, B2, B3, B5, B6, B7, B9, B12) are essential for brain function and energy production. They support the synthesis of neurotransmitters that improve mood, memory, and concentration, and help combat stress and mental fatigue. Together, they contribute to protecting brain cells and maintaining cognitive performance.
- CAFFEINE: The stimulating and invigorating effects of caffeine on the brain and nervous system have been known for centuries. Caffeine is a mild psychostimulant with invigorating effects. It also alleviates symptoms of fatigue and enhances work capacity. Moreover, moderate amounts of caffeine are known to have a stimulating effect on the cerebrocortical fields responsible for thinking: it enhances mental activity, improves cognitive functions, and accelerates mental associations. In this way, caffeine's stimulating effect can also lead to an improved sense of well-being Our aim is test the hypothesis that Cortexium dietary supplement improves cognitive function in postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Good general health.
- •Education level at least completed elementary.
- •Menopausal status with minimum 1 year from the last menstrual period and based on the criterion of follicle-stimulating hormone (FSH) level (FSH > 30 mlU/ml) or a history of bilateral oophorectomy.
排除标准
- •Active cancerous disease within the period of 5 years before recruitment.
- •Mental diseases in medical history, including depression.
- •Addiction to drugs and alcohol.
- •Symptoms of dementia or history of neurological treatment or neurocognitive disorder.
研究组 & 干预措施
Placebo
Participant will receive matching placebo supplement daily over a period of 6 weeks.
干预措施: Placebo food supplement (Dietary Supplement)
Treatment
Participants will receive Cortexium (a specially formulated dietary supplement with pyrroloquinoline quinone, γ-aminobutyric acid and B vitamins).
干预措施: Cortexium food supplement (Dietary Supplement)
结局指标
主要结局
Neurocognition Index (NCI)
时间窗: From enrollment to the end of treatment at 6 weeks.
Neurocognition Index (NCI) as calculated by Cognitive functions using the diagnostic instrument Central Nervous System-Vital Signs (CNS-VS) computerized neuropsychological / neurocognitive test.
次要结局
- Central Nervous System-Vital Signs (CNS-VS)(From enrollment to the end of treatment at 6 weeks.)
