Social stress induces neurovascular pathology promoting depression.
Caroline Menard, Madeline L Pfau, Georgia E Hodes...
https://pubmed.ncbi.nlm.nih.gov/29184215Actively Recruiting
Phase Not Applicable
Age: 50Years - 65Years
All Genders
Healthy Volunteers
ID05541887
Acute and Chronic Effects of Muscadine Wine Polyphenols on Cognition, Memory, Mood, and Anxiety in Adults Aged 50 to 65
Led by University of Florida · Updated on 2025-06-12
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how muscadine wine polyphenols may affect brain health, including cognition, memory, mood, and anxiety in healthy adults aged 50 to 65. The study explores the idea that these polyphenols might improve brain function by regulating the hypothalamic-pituitary-adrenal (HPA) axis, reducing inflammation and oxidative stress, and inhibiting monoamine oxidase activities. This trial aims to provide the first clinical evidence on the effects and mechanisms of muscadine wine polyphenols on mental and cognitive health. Participants will be randomly assigned to one of two groups. One group will consume muscadine wine polyphenols for six weeks, followed by a 21-day washout period, then a placebo for six weeks. The other group will take the placebo first, followed by washout and then muscadine wine polyphenols. The muscadine wine polyphenol is a dealcoholized beverage with less than 0.5% alcohol content, while the placebo matches sugar, acid content, and color but contains no polyphenols. During the trial, participants will undergo assessments of cognitive performance, mood, anxiety, depression, and various biological markers at baseline, four hours after a single dose, and after six weeks of treatment or placebo. These include tests of cognitive function, measurements of monoamine oxidase activity, brain-derived neurotrophic factors, inflammatory markers, and cortisol levels. The study will track acute and chronic effects over the treatment periods and monitor safety and adherence throughout the trial, which is expected to continue until late 2026.
CONDITIONS
Brief Title
Use Muscadine Wine Nutraceuticals to Improve Brain Health, Cognition, and Mental Health
Who Can Participate
Age: 50Years - 65Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Healthy
- Body mass index between 18.5 and 29.9
- Body weight at least 110 pounds
- Age between 50 and 65 years
- Both males and females
You will not qualify if you...
- Pregnant or breastfeeding
- Current smoker
- Diabetic
- Heavy alcohol drinker
- Cognitive impairment with Montreal cognitive assessment score below 26
- Unable to understand cognitive function tasks
- Use of medications that may affect study outcomes (e.g., psychostimulants)
- Cannabis product user
- Clinically diagnosed mental illnesses
- Cardiovascular or neurological disorders
- Uncontrolled high blood pressure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 weeks for each treatment phase separated by a 21-day washout period
Participants consume muscadine wine polyphenol and placebo in a crossover design to assess effects on cognition, memory, mood, and anxiety.
Multiple visits including baseline, acute (4-hour post single dose), and end of each 6-week phase assessments
Trial Site Locations
Total: 1 location
1
Food Science and human nutrition department at University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
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Research Team
K
Kylee Mai
L
Liwei Gu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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