Clinical Trial

Genistein, Equol, Cognitive Function and Mood: Twelve-week. (GECFAMc)

Study acronym: GECFAMc
Completed
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Summary
Isoflavones (ISF) are naturally occurring compounds that can provide protective benefits for certain domains of cognitive function. Studies on the prevalence of cognitive decline and cancers in the Asian diet-eating areas of the world have investigated the effects of the ISFs and how they affect human bodies and brains. Previous literature has shown that ISFs are capable of activating oestrogen receptors in brains that provide protection in terms of long-term potentiation as well antioxidation, anti-inflammatory and promoting the growth and interaction of neurons (e.g., BDNF upregulation). Genistein is a bioactive ISF having been shown to provide a strong protective response in our brains and other aspects of healthcare; Equol is a metabolite of Daidzein and is thought to provide a similar (or stronger) response than Genistein due to its receptor binding strength. Not everyone is capable of digesting Equol from other Isoflavones (Daidzein) and therefore supplementing this directly could provide neurological benefits at a similar level, if not stronger than, Genistein. This twelve-week three-arm study will aim to evaluate the efficacies of two ISFs (Genistein and Equol) versus a control group. ISF are "Generally Recognised As Safe" ("GRAS") molecules by the United States of America's classification regulatory commission the Federal Drug Administration as well as deemed "Safe" by the European Food Safety Authority (EFSA). Participants will be required to undertake 4 one-hour-long sessions. Interventions will be taken once daily. This investigative team hypothesise that both ISFs will elicit significant positive changes in cognitive functions, specifically to spatial/verbal working memory, executive function, and speed of processing and measures of mood with a variation in effect due to age likely, the lacking restriction for age will allow for this as a covariate dependent on recruitment outcome.
Trial Details
NCT Number NCT07742501
Lead Sponsor University of Reading
Conditions Cognition, Mood
Enrollment 51 participants
Start Date 2024-11-01
Primary Completion 2025-10-14 (estimated)
Study Completion 2025-10-14 (estimated)
Updated on ClinicalTrials.gov 2026-08-03