Effects of Japanese Red Wines on Vascular Function in Adult Men

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Japanese Red Wines on Vascular Function in Adult Men

Conditions
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Vascular Function; Platelet Aggregation

Intervention / Treatment
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* Other: Red wine A
* Other: Red wine B
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Three-way crossover randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Participants in this group are randomized to receive Isocaloric beverage (a beverage that has similar caloric content to the red wines) as the first intervention. | Other: Red wine A<br>* 8 oz (237 ml) of red wine A and red wine B will be blinded and randomized between Japanese Zweigelt red wines from vintages 2015 or 2018.<br>Other: Red wine B<br>* 8 oz (237 ml) of red wine A and red wine B will be blinded and randomized between Japanese Zweigelt red wines from vintages 2015 or 2018.<br>Other: Control<br>* 8 oz (237 ml) of control beverage is a beverage that has similar calories to red wines.<br>|
| Experimental: Red wine A<br>Participants in this group are randomized to receive red wine A as the first intervention (can be the younger or older vintage). | Other: Red wine A<br>* 8 oz (237 ml) of red wine A and red wine B will be blinded and randomized between Japanese Zweigelt red wines from vintages 2015 or 2018.<br>Other: Red wine B<br>* 8 oz (237 ml) of red wine A and red wine B will be blinded and randomized between Japanese Zweigelt red wines from vintages 2015 or 2018.<br>Other: Control<br>* 8 oz (237 ml) of control beverage is a beverage that has similar calories to red wines.<br>|
| Experimental: Red wine B<br>Participants in this group are randomized to receive red wine B as the first intervention (can be the younger or older vintage) | Other: Red wine A<br>* 8 oz (237 ml) of red wine A and red wine B will be blinded and randomized between Japanese Zweigelt red wines from vintages 2015 or 2018.<br>Other: Red wine B<br>* 8 oz (237 ml) of red wine A and red wine B will be blinded and randomized between Japanese Zweigelt red wines from vintages 2015 or 2018.<br>Other: Control<br>* 8 oz (237 ml) of control beverage is a beverage that has similar calories to red wines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral Arterial Tonometry (PAT) | Endothelial function | Baseline | 
| Peripheral Arterial Tonometry (PAT) | Endothelial function | 2 hours after beverage consumption | 
| Peripheral Arterial Tonometry (PAT) | Endothelial function | 4 hours after beverage consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet Aggregation | Light Transmission Aggregometry | Baseline and 2 and 4 hours after beverage consumption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular function; platelet aggregation