Effects of Japanese Red Wines on Vascular Function in Adult Men

NCT ID: NCT05138939

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-17
• Study Completion Date: 2023-02-04

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.

Conditions

Vascular Function; Platelet Aggregation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control

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.

Group Type: PLACEBO_COMPARATOR

Red wine A

Intervention Type: OTHER

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.

Red wine B

Intervention Type: OTHER

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.

Control

Intervention Type: OTHER

8 oz (237 ml) of control beverage is a beverage that has similar calories to red wines.

Red wine A

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

Group Type: EXPERIMENTAL

Red wine A

Intervention Type: OTHER

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.

Red wine B

Intervention Type: OTHER

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.

Control

Intervention Type: OTHER

8 oz (237 ml) of control beverage is a beverage that has similar calories to red wines.

Red wine B

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

Group Type: EXPERIMENTAL

Red wine A

Intervention Type: OTHER

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.

Red wine B

Intervention Type: OTHER

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.

Control

Intervention Type: OTHER

8 oz (237 ml) of control beverage is a beverage that has similar calories to red wines.

Interventions

Red wine A

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.

Intervention Type: OTHER

Red wine B

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.

Intervention Type: OTHER

Control

8 oz (237 ml) of control beverage is a beverage that has similar calories to red wines.

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert M Hackman, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, UC Davis

Locations

Ragle Human Nutrition Research Center

Davis, California, United States

Countries

United States

Other Identifiers

1306528

Identifier Type: -

Identifier Source: org_study_id