Investigation of Genistein and Equol's Effects on Cognitive Function Domains and Mood Measures in a Post-prandial Time-frame, Placebo-controlled and Double-blind Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Reading
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Post-prandial effect of Genistein or Equol versus placebo on verbal memory and learning
Study Overview
Brief 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 our bodies and brains. Previous literature has shown that ISFs are capable of binding oestrogen receptors in our brains that provide protection in terms of antioxidation, anti-inflammatory and promoting the growth and interaction of our brain cells.
Genistein is an important ISF having been shown to provide a strong protective response in our brains and other aspects of healthcare; Equol is a metabolite of ISF and is thought to provide a similar (or stronger) response than Genistein due to its receptor binding strength. Unfortunately, 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 acute study will aim to evaluate the efficacies of two ISFs (Genistein and Equol) versus a control group, in an immediately post-prandial timeframe. SIF 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). Participant will be required to undertake 2 one hour-long sessions. Interventions will be taken once after the baseline task battery is completed.
Detailed Description
The design of this study is as a three-arm, placebo controlled, double-blind with between-groups comparison. Adult participants aged 18 years old and over will be recruited to the study from the local community. After demonstrating an initial interest in the study, participants will be sent the participant information sheet, a health and lifestyle questionnaire, and FFQ to assess habitual diets, supplements and medications. A screening interview will be used to answer the health and lifestyle questionnaire and participants who meet the screening criteria will be able to undergo a practice session where they will sign a consent form and familiarise themselves with the cognitive tasks and mood questionnaires. Recruitment materials will include posting posters advertising as well as posts on pertinent social media outlets.
Following a this screening session wherein we will check exclusion/inclusion criteria have been met; participants will be randomly allocated to interventions consisting of a control group (maltodextrin), a genistein group (70mg/day) and an equol group (70mg/day). Participants will also undergo a familiarisation session with the computerised software at this screening session. Return appointments will be made for the study day and participants will be reminded of their right to withdraw from the study at any point. Helplines and web links with support and advice will be provided (Mind, Alzheimer's Society, Dementia UK) alongside advice to contact their GP should they require medical support.
On the testing day, between 7-14 days after the screening visit, participants will attend the laboratory after consuming their standard breakfast, but to refrain from consuming any caffeine-containing products. Upon arrival at the University, participants will be asked to complete a battery of cognitive tasks and to complete the mood measure after this.
On completion of the battery, they will be supplied with their intervention capsule and asked to consume it in front of the researcher. After the two-hour break to allow for absorption and circulation, the participants will complete the task battery of cognitive and mood measures.Our task battery is composed of cognitive tests are categorised into one of three cognitive domains pertinent to neurotransmitter and oestrogen receptor functions, speed of processing/memory/executive function whilst changes in current mood state will be measured using the PANAS-Now.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Masking Description
Investigator masked from intervention group by third-party and participant blinded to intervention composition.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Not currently undertaking medications including but not limited to Hormone Replacement Therapy
- •Generally Healthy
Exclusion Criteria
- •Participant (female) has not menstruated in >12 months (post-menopausal).
- •Allergy to soy
Arms & Interventions
Maltodextrin
Maltodextrin powder at 70mg (encapsulated).
Intervention: Maltodextrin (Placebo) (Dietary Supplement)
Equol
Powdered equol at 70mg (encapsulated).
Intervention: Equol (Dietary Supplement)
Genistein
Powdered genistein at 70mg (encapsulated)
Intervention: Genistein (Dietary Supplement)
Outcomes
Primary Outcomes
Post-prandial effect of Genistein or Equol versus placebo on verbal memory and learning
Time Frame: 4 hours
Rey auditory verbal learning task: Immediate Recall Total Acquisition Final Acquisition Delayed Recall Hits Recognition Score
Post-prandial effect of Genistein or Equol versus placebo on spatial working memory
Time Frame: 4 hours
Corsi Block-Tapping Task: Correct Blocks Correct Sequences Reaction Time Initial Reaction Time
Post-prandial effect of Genistein or Equol versus placebo on executive function (set-switching and cognitive flexibility)
Time Frame: 4 hours
Task-Switching Task: Accuracy Switch Cost Reaction Time
Post-prandial effect of Genistein or Equol versus placebo on speed of processing and executive function
Time Frame: 4 hours
Trail-Making Test: Time to complete Part A Time to complete Part B B-A = Difference Score B/A = Ratio Score
Secondary Outcomes
- Post-prandial effect of Genistein or Equol versus placebo on mood items(4 hours)
Investigators
Prof Claire Williams
Professor
University of Reading