Clinical trial NCT05541887: Use Muscadine Wine Nutraceuticals to Improve Brain Health, Cognition, and Mental Health
Official title: Acute and Chronic Impacts of Muscadine Wine Polyphenols on Cognition, Memory, Mood, and Anxiety in Adults Over 50 Years of Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Performance
Memory
Mood
Anxiety
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Previous studies have shown that polyphenol-rich foods can positively affect cognitive functions, memory, and mood in humans. We hypothesize that both acute and chronic intake of muscadine wine polyphenols will improve cognitive performance and mood through regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities

Detailed description: Although the exact biological mechanisms for depression and Alzheimer's Disease are not fully understood, it's believed that they are caused by a combination of factors. An increasing amount of scientific research has proposed several possible pathophysiologies linking depression and AD. For example, increased production of pro-inflammatory cytokines in the nervous system, oxidative stress induced by chronic inflammation leads to dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, and disturbance in the brain-derived neurotrophic factor signal pathway. Polyphenol has been well recognized for its antioxidant and anti-inflammatory properties. Previous studies have shown that polyphenol-rich food such as concord grape juice, blueberries, blackcurrants, and green oats positively affect cognition, memory, and mood in humans. However, no one has examined the effects of muscadine wine polyphenol on cognitive and mental health. In addition, if they do have effects, through what mechanism? This clinical trial will allow us to investigate the questions raised. We hypothesize that intake of muscadine wine polyphenols enhances cognition and memory and improve depression and anxiety in healthy adults over 50 year-old via regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities. The research will provide the first clinical evidence of how muscadine wine polyphenols affect the brain and mental health.

Eligibility criteria: Inclusion Criteria:

* Healthy
* BMI (18.5-29.9)
* Body weight ≥110 pounds

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Smokers
* Diabetic
* Heavy drinkers
* Subjective but not clinically diagnosed cognitive impairment (Montreal cognitive assessment score \<26),
* Inability to understand the cognitive function tasks
* Intake of medication that might influence the outcome of the study (e.g. psychostimulant)
* cannabis product user
* Clinically diagnosed mental illnesses
* Cardiovascular and neurological disorders
* Uncontrolled hypertension

Primary outcomes:
measure: Change from baseline cognitive performance score after intervention/placebo
timeFrame: Baseline, acute (4-hour post single dose), chronic (end of six week)
measure: Change from baseline cognitive performance score after intervention/placebo - continued
timeFrame: Baseline, acute (4-hour post single dose), chronic (end of six week)
measure: Change from baseline cognitive performance score after intervention/placebo - continued
timeFrame: Baseline, acute (4-hour post single dose), chronic (end of six week)
measure: Change from baseline monoamine oxidase (MAOs) activity
timeFrame: Baseline, acute (4-hour post single dose), chronic (end of six week)
measure: Change from baseline neurotransmitters
timeFrame: Baseline, acute (4-hour post single dose), chronic (end of six week)
measure: Change from baseline brain-derived neurotrophic factors
timeFrame: Baseline, acute (4-hour post single dose), chronic (end of six week)
measure: Change from baseline cortisol, TNF-α, high sensitivity C-reactive protein, and LPS binding protein
timeFrame: Baseline, acute (4-hour post single dose), chronic (end of six week)
Secondary outcomes:
measure: Change from baseline mood and anxiety score after intervention/placebo
timeFrame: Baseline, acute (4-hour post single dose), chronic (end of six week)
measure: Change from baseline depression score after intervention/placebo
timeFrame: Baseline, acute (4-hour post single dose), chronic (end of six week)
measure: Change from baseline pro-inflammatory cytokines
timeFrame: Baseline, acute (4-hour post single dose), chronic (end of six week)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Food Science and human nutrition department at University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Liwei Gu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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