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

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.

Conditions

• Cognition
• Mood

Interventions

DIETARY_SUPPLEMENT

Equol

Equol is a metabolite of the Isoflavone Daidzein, metabolised in roughly 10-20% of the western population.

DIETARY_SUPPLEMENT

Genistein

Genistein is a neuroprotective Isoflavone commonly found in Glycine Max (Soy).

DIETARY_SUPPLEMENT

Maltodextrin

Maltodextrin is the placebo control used in this study. A non-neuroactive starch derived polysaccharide .

Sponsors & Collaborators

• University of Reading

  lead OTHER

Principal Investigators

• Claire Williams, PhD · University of Reading

• Daniel Lamport, PhD · University of Reading

• Luke R Till, MSc · University of Reading

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-01

Primary Completion

2025-10-14

Completion

2025-10-14

Countries

• United Kingdom

Study Locations