Clinical trial NCT05138939: Effects of Japanese Red Wines on Vascular Function in Adult Men
Official title: Effects of Japanese Red Wines on Vascular Function in Adult Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Function; Platelet Aggregation
Keywords: vascular function; platelet aggregation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 10
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three-way crossover randomized controlled trial
Primary purpose: OTHER

Brief summary: The overall objective of this study is to investigate the effects of different types of red wine on markers of endothelial function and platelet aggregation.

Detailed description: Potential participants are provided with information about the study and potential risks. Once participants decided to participate in the study, they will be scheduled for a health screening visit which determines eligibility to the study entry. If participants are eligible, they will be randomized in a three-way crossover study design to receive three interventions (control, red wine1, and red wine2) with the one-week washout period. On the study day, participants will be assessed for baseline measurements, provided with the designated beverage, and followed up for the measurements at 2 and 4 hours after the consumption.

Eligibility criteria: Inclusion Criteria:

* Male: 50-70 years old
* Subject is willing and able to comply with the study protocols.
* Subject is willing to participate in all study procedures
* BMI 18.5 - 40 kg/m2
* Weight ≥ 110 pounds
* Prescription medication if on a 6-month self-reported stable dose
* Regularly consume alcoholic beverages (2 drinks/week to 2 drinks/day)
* Non-smokers
* One standard drink of alcoholic beverages is defined as follow:

  12-ounces of beer (5% alcohol content) (\~1 regular bottle). 8-ounces of malt liquor (7% alcohol content) (\~1 regular bottle). 5-ounces of wine (12% alcohol content) (\~½ glass) 1.5-ounces of 80-proof (40% alcohol content) distilled spirits or liquor (e.g., gin, rum, vodka, whiskey) (\~ 1 shot)

Exclusion Criteria:

* BMI ≥ 40 kg/m2
* Daily use of aspirin or NSAIDs
* Dislike or allergic to any food, especially wine, grape, and alcohol
* Vegan, Vegetarians, food faddists, or those consuming a non-traditional diet
* Alcohol consumption \< 2 drinks/week (i.e. 1 bottle of beer, ½ glass of wine, and 1 shot of hard liquor)
* Alcohol consumption \> 2 drinks/ day
* Fruit consumption ≥ 2 cups/day
* Vegetable consumption ≥ 3 cups/day
* Fatty Fish ≥ 3 times/week
* Coffee/tea ≥ 3 cups/day
* Dark chocolate ≥ 3 oz/day
* Self-reported restriction of physical activity due to a chronic health condition
* Self-reported chronic/routine high intensity exercise
* Self-reported diabetes
* Blood pressure ≥ 140/90 mm Hg
* Self-reported renal or liver disease
* Self-reported heart disease, which includes cardiovascular events and Stroke
* Self-reported Cushing's syndrome
* Self-reported chronic/routine high-intensity exercise
* Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
* Abnormal Liver or Chemistry panels (laboratory values outside the reference range) if determined to be clinically significant by the study physician.
* Self-reported cancer within the past 5 years
* Self-reported malabsorption
* Use of multi-vitamin and minerals other than a general formula of vitamins and minerals that meet the recommended dietary allowance (RDA)
* Not willing to stop any supplement use, including herbal, plant or botanical, fish oil, oil supplements a month prior to study enrollment.
* Indications of substance or alcohol abuse within the last 3 years
* Current enrollee in a clinical research study.
* Reactive hyperemia index (RHI) value ≥ 2.8 (measured by PAT at the first study visit)
* Raynaud's disease, history of bleeding disorder and/or abnormal bleeding, and history of gastrointestinal ulceration and/or bleeding
* Under current medical supervision
* 1 ug/ml and 3 ug/ml collagen screening maximal platelet aggregatory response of \< 65%.
* Platelet number or mean platelet values that are outside of the normal reference range as indicated on a complete blood cell count report from the University of California Davis Medical Center
* Current diagnosis of anemia; or a screening hemoglobin and hematocrit that is less than the normal reference range.Individuals with blood clotting or platelet defect disorders

The following special populations will be excluded:

* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners

Primary outcomes:
measure: Peripheral Arterial Tonometry (PAT)
timeFrame: Baseline
measure: Peripheral Arterial Tonometry (PAT)
timeFrame: 2 hours after beverage consumption
measure: Peripheral Arterial Tonometry (PAT)
timeFrame: 4 hours after beverage consumption
Secondary outcomes:
measure: Platelet Aggregation
timeFrame: Baseline and 2 and 4 hours after beverage consumption
Other outcomes:
Locations:
city: Davis
country: United States
facility: Ragle Human Nutrition Research Center
state: California
Study officials:
affiliation: Department of Nutrition, UC Davis
name: Robert M Hackman, PhD
role: PRINCIPAL_INVESTIGATOR
References: