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Effects of Japanese Red Wines on Vascular Function in Adult Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05138939
Recruitment Status : Recruiting
First Posted : December 1, 2021
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Vascular Function; Platelet Aggregation Other: Red wine A Other: Red wine B Other: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Three-way crossover randomized controlled trial
Masking: Single (Participant)
Masking Description: Participants will be blinded by the type of beverages (control, red wine1, and red wine2).
Primary Purpose: Other
Official Title: Effects of Japanese Red Wines on Vascular Function in Adult Men
Actual Study Start Date : November 17, 2021
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023

Arm Intervention/treatment
Placebo Comparator: 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.
Other: 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.

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.

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

Experimental: 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).
Other: 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.

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.

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

Experimental: 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)
Other: 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.

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.

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




Primary Outcome Measures :
  1. Peripheral Arterial Tonometry (PAT) [ Time Frame: Baseline ]
    Endothelial function

  2. Peripheral Arterial Tonometry (PAT) [ Time Frame: 2 hours after beverage consumption ]
    Endothelial function

  3. Peripheral Arterial Tonometry (PAT) [ Time Frame: 4 hours after beverage consumption ]
    Endothelial function


Secondary Outcome Measures :
  1. Platelet Aggregation [ Time Frame: Baseline and 2 and 4 hours after beverage consumption ]
    Light Transmission Aggregometry



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05138939


Contacts
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Contact: Prae Charoenwoodhipong, MS 530-761-6183 pcharoen@ucdavis.edu

Locations
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United States, California
Ragle Human Nutrition Research Center Recruiting
Davis, California, United States, 95616
Contact: Jody Randolph    530-752-7620    jmrandolph@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Robert M Hackman, PhD Department of Nutrition, UC Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT05138939    
Other Study ID Numbers: 1306528
First Posted: December 1, 2021    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
vascular function; platelet aggregation