Cognitive Effects of a Dietary Supplement With PQQ, GABA, Caffeine, and B-Vitamins in Healthy Postmenopausal Women: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cortexium food supplement, Placebo food supplement.
- Who it may be relevant to
- Registry conditions: Cognitive Function and Memory. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Dietary supplement Cortexium food supplement
Cortexium (a specially formulated dietary supplement with pyrroloquinoline quinone, γ-aminobutyric acid and B vitamins). - Dietary supplement Placebo food supplement
Placebo food supplement is completely identical weight and outlook capsule to Cortexium, with 50% microcrystalline cellulose and 50% starch.
Primary outcome measures
- Neurocognition Index (NCI) [Time frame: From enrollment to the end of treatment at 6 weeks.]
Secondary outcome measures (1)
- Central Nervous System-Vital Signs (CNS-VS) [Time frame: From enrollment to the end of treatment at 6 weeks.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Hungary · 1 center
- Dr. Secret Private Clinic — Debrecen
Identifiers
NCT: NCT06748989 · 2025CORTEXIUM