Clinical trial NCT06748989: Cognitive Effects of a Dietary Supplement with PQQ, GABA, Caffeine, and B-Vitamins in Healthy Postmenopausal Women: a Randomized Controlled Trial
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Function and Memory
Lead sponsor: FEMPHARMA Kft.
Sponsor class: INDUSTRY
First posted: 2024-12-27
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Neurocognition Index (NCI)
timeFrame: From enrollment to the end of treatment at 6 weeks.
Secondary outcomes:
measure: Central Nervous System-Vital Signs (CNS-VS)
timeFrame: From enrollment to the end of treatment at 6 weeks.
Other outcomes:
Locations:
city: Debrecen
country: Hungary
facility: Dr. Secret Private Clinic
state: HB
Study officials:
References: