Purpose

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

Conditions

Eligibility

Eligible Ages
Between 50 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Supportive Care
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Intervention-Placebo
Participants in this arm will consume muscadine wine polyphenol for six weeks and then placebo for another six weeks. The two phases are separated by a 21-day washout period
  • Other: Muscadine Wine Polyphenol
    dealcoholized muscadine wine with alcohol content <0.5% with addition of 50ppm of sodium metabisulfite for preservation
    Other names:
    • Dealcoholized Muscadine Wine
  • Other: Placebo
    this placebo beverage is formulated with matching sugar and organic acid content to the muscadine wine polyphenol. Food coloring is added to match the color of the intervention. 50ppm of sodium metabisulfite for preservation
Active Comparator
Placebo-Intervention
Participants in this arm will first consume placebo for six weeks and then muscadine wine polyphenol for another six weeks. The two phases are separated by a 21-day washout period
  • Other: Muscadine Wine Polyphenol
    dealcoholized muscadine wine with alcohol content <0.5% with addition of 50ppm of sodium metabisulfite for preservation
    Other names:
    • Dealcoholized Muscadine Wine
  • Other: Placebo
    this placebo beverage is formulated with matching sugar and organic acid content to the muscadine wine polyphenol. Food coloring is added to match the color of the intervention. 50ppm of sodium metabisulfite for preservation

Recruiting Locations

More Details

Status
Recruiting
Sponsor
University of Florida

Study Contact

Kylee Mai
479-203-8170
cmai1@ufl.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.