Vascular Function; Platelet AggregationNCT05138939
Effects of Japanese Red Wines on Vascular Function in Adult Men
A study testing Red wine A and Red wine B in people with Vascular Function; Platelet Aggregation, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vascular Function; Platelet Aggregation
- What is being tested?
- Red wine A and Red wine B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2021to 4 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Show all 37Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Ragle Human Nutrition Research Center
Davis, California, 95616
About this study
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.
Read the 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
- Being tested
- Red wine A, Red wine B, Control
- Keywords
- vascular function; platelet aggregation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red wine AOther
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 BOther
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.
ControlOther
8 oz (237 ml) of control beverage is a beverage that has similar calories to red wines.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 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. Receives: Other: Red wine A; Other: Red wine B; Other: Control |
| Red wine A | Experimental | Participants in this group are randomized to receive red wine A as the first intervention (can be the younger or older vintage). Receives: Other: Red wine A; Other: Red wine B; Other: Control |
| Red wine B | Experimental | Participants in this group are randomized to receive red wine B as the first intervention (can be the younger or older vintage) Receives: Other: Red wine A; Other: Red wine B; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Arterial Tonometry (PAT)
Endothelial function
Measured: Baseline
Peripheral Arterial Tonometry (PAT)
Endothelial function
Measured: 2 hours after beverage consumption
Peripheral Arterial Tonometry (PAT)
Endothelial function
Measured: 4 hours after beverage consumption
Secondary outcomes (1)
Platelet Aggregation
Light Transmission Aggregometry
Measured: Baseline and 2 and 4 hours after beverage consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start17 Nov 2021
- Primary completion4 Feb 2023
- Study completion4 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Function; Platelet AggregationStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three-way crossover randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert M Hackman, PhD, Principal investigator, Department of Nutrition, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138939
- Sponsor's protocol ID
- 1306528
- Status last verified
- Jun 2023
- First submitted
- 15 Nov 2021
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Japanese Red Wines on Vascular Function in Adult Men
- ClinicalTrials.gov ID
- NCT05138939
- Acronym / sponsor ID
- 1306528
- Conditions
- Vascular Function; Platelet Aggregation
- Keywords
- vascular function; platelet aggregation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 4 Feb 2023 (actual)
- Study completion
- 4 Feb 2023 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three-way crossover randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Red wine A, Other: Red wine B, Other: ControlParticipants in this group are randomized to receive Isocaloric beverage (a beverage that has similar caloric content to the red wines) as the first intervention. |
| Red wine A | Experimental | Other: Red wine A, Other: Red wine B, Other: ControlParticipants in this group are randomized to receive red wine A as the first intervention (can be the younger or older vintage). |
| Red wine B | Experimental | Other: Red wine A, Other: Red wine B, Other: ControlParticipants in this group are randomized to receive red wine B as the first intervention (can be the younger or older vintage) |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (37 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red wine A8 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, Red wine A, Red wine B |
| Red wine B8 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, Red wine A, Red wine B |
| Control8 oz (237 ml) of control beverage is a beverage that has similar calories to red wines. | Other | Control, Red wine A, Red wine B |
Primary outcome
Peripheral Arterial Tonometry (PAT)
Time frame: Baseline
Endothelial function
Peripheral Arterial Tonometry (PAT)
Time frame: 2 hours after beverage consumption
Endothelial function
Peripheral Arterial Tonometry (PAT)
Time frame: 4 hours after beverage consumption
Endothelial function
1 secondary outcome
Platelet Aggregation
Time frame: Baseline and 2 and 4 hours after beverage consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Hackman, PhD principal investigator
Department of Nutrition, UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red wine A and Red wine B in people with Vascular Function; Platelet Aggregation, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Arterial Tonometry (PAT) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.