Effects of Japanese Red Wines on Vascular Function in Adult Men

University of California (UC) Davis

Status

Completed

Conditions

Vascular Function; Platelet Aggregation

Treatments

Other: Red wine A

Other: Control

Other: Red wine B

Study type

Interventional

Funder types

Other

Identifiers

NCT05138939

1306528

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

Male

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

10 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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.

Treatment:

Other: Control

Other: Red wine B

Other: Red wine A

Red wine A

Experimental group

Description:

Participants in this group are randomized to receive red wine A as the first intervention (can be the younger or older vintage).

Treatment:

Other: Control

Other: Red wine B

Other: Red wine A