Endothelial DysfunctionNCT03806829
The Acute Effects of Commercially Available Drinks on the Endothelial Function of Humans Following a High-fat Meal
A study testing Water, Red Wine and Green Tea in people with Endothelial Dysfunction, run by University of the Highlands and Islands at 1 site in United Kingdom.
Trial summary
High fat diets are associated with impaired endothelial function and increased cardiovascular disease risk amongst our population. These negative effects are likely caused by triglyceride induced suppression of nitric oxide, which is produced from the endothelium, and/or an increase in oxidative stress. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Water, Red Wine and Green Tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2018to 31 Jul 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females to be postmenopausal and not on hormone replacement therapy
- 25 > BMI < 35
- Sedentary to light activity lifestyle.
Who cannot join
- History of cardiovascular disease (Hypertension, Atherosclerosis, endothelial issues etc).
- History of diabetes (Type 1 or type 2)
- Vegan or with food allergies or intolerances.
- Taking any antioxidants over the counter (Vit C, E or polyphenol supplements)
- Taking prescription medication for hypertension.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of the Highlands and Islands
Inverness, IV2 3JH
About this study
Official title: Pilot Study: The Acute Effects of Commercially Available Drinks on the Endothelial Function of Humans Following a High-fat Meal
High fat diets are associated with impaired endothelial function and increased cardiovascular disease risk amongst our population. These negative effects are likely caused by triglyceride induced suppression of nitric oxide, which is produced from the endothelium, and/or an increase in oxidative stress.
Interestingly, previous studies have found that some beverages that are high in polyphenols and antioxidants may suppress the impairment in endothelial function observed following high fat meals/diets. Typically, these studies have investigated the ingestion of red wine, orange juice or green tea on outcome measures (typically flow mediated dilatation (FMD) of the brachial artery). Despite this previous research, no study has compared the effects of different beverages on endothelial outcomes following a high-fat meal within the same participants.
- Conditions
- Endothelial Dysfunction
- Being tested
- Water, Red Wine, Green Tea, Orange Juice
- Keywords
- antioxidants, polyphenols, flow-mediated dilatation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
250 ml
Red WineOther
250 ml
Green TeaOther
250 ml
Orange JuiceOther
250 ml
| Study group | Role | What they receive |
|---|---|---|
| Water + Meal | Active comparator | 250 ml Water and a high calorie, high fat meal (>900 kcal, 50g fat) Receives: Other: Water |
| Red Wine + Meal | Experimental | 250 ml Red Wine and a high calorie, high fat meal (>900 kcal, 50g fat) Receives: Other: Red Wine |
| Green Tea + Meal | Experimental | 250 ml Green Tea and a high calorie, high fat meal (>900 kcal, 50g fat) Receives: Other: Green Tea |
| Orange Juice + Meal | Experimental | 250 ml Orange Juice and a high calorie, high fat meal (>900 kcal, 50g fat) Receives: Other: Orange Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial (dys)function
Assessed via flow mediated dilatation
Measured: 2 hours post-prandial
Secondary outcomes (3)
Plasma Nitrite
Measured: 2 hours post-prandial
Plasma antioxidant capacity
Plasma oxygen radical absorbance capacity
Measured: 2 hours post-prandial
Plasma ox-LDL
Measured: 2 hours post-prandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start6 Jun 2018
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Highlands and Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Megson, Megson, Principal investigator, University of the Highlands and Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806829
- Sponsor's protocol ID
- ETHSHE1376
- Status last verified
- Jan 2019
- First submitted
- 14 Jan 2019
- Last updated
- 16 Jan 2019
- 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 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: The Acute Effects of Commercially Available Drinks on the Endothelial Function of Humans Following a High-fat Meal
- ClinicalTrials.gov ID
- NCT03806829
- Acronym / sponsor ID
- ETHSHE1376
- Conditions
- Endothelial Dysfunction
- Keywords
- antioxidants, polyphenols, flow-mediated dilatation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of the Highlands and IslandsUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 16 Jan 2019 (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.
High fat diets are associated with impaired endothelial function and increased cardiovascular disease risk amongst our population. These negative effects are likely caused by triglyceride induced suppression of nitric oxide, which is produced from the endothelium, and/or an increase in oxidative stress.
Interestingly, previous studies have found that some beverages that are high in polyphenols and antioxidants may suppress the impairment in endothelial function observed following high fat meals/diets. Typically, these studies have investigated the ingestion of red wine, orange juice or green tea on outcome measures (typically flow mediated dilatation (FMD) of the brachial artery). Despite this previous research, no study has compared the effects of different beverages on endothelial outcomes following a high-fat meal within the same participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Water + Meal | Active comparator | Other: Water250 ml Water and a high calorie, high fat meal (>900 kcal, 50g fat) |
| Red Wine + Meal | Experimental | Other: Red Wine250 ml Red Wine and a high calorie, high fat meal (>900 kcal, 50g fat) |
| Green Tea + Meal | Experimental | Other: Green Tea250 ml Green Tea and a high calorie, high fat meal (>900 kcal, 50g fat) |
| Orange Juice + Meal | Experimental | Other: Orange Juice250 ml Orange Juice and a high calorie, high fat meal (>900 kcal, 50g fat) |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females to be postmenopausal and not on hormone replacement therapy
- 25 > BMI < 35
- Sedentary to light activity lifestyle.
Key exclusion criteria (5 listed)
- History of cardiovascular disease (Hypertension, Atherosclerosis, endothelial issues etc).
- History of diabetes (Type 1 or type 2)
- Vegan or with food allergies or intolerances.
- Taking any antioxidants over the counter (Vit C, E or polyphenol supplements)
- Taking prescription medication for hypertension.
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 |
|---|---|---|
| Water250 ml | Other | Water + Meal |
| Red Wine250 ml | Other | Red Wine + Meal |
| Green Tea250 ml | Other | Green Tea + Meal |
| Orange Juice250 ml | Other | Orange Juice + Meal |
Primary outcome
Endothelial (dys)function
Time frame: 2 hours post-prandial
Assessed via flow mediated dilatation
3 secondary outcomes
Plasma Nitrite
Time frame: 2 hours post-prandial
Plasma antioxidant capacity
Time frame: 2 hours post-prandial
Plasma ox-LDL
Time frame: 2 hours post-prandial
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 16 Jan 2019.
- 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.
Ian Megson, Megson principal investigator
University of the Highlands and Islands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water, Red Wine and Green Tea in people with Endothelial Dysfunction, run by University of the Highlands and Islands at 1 site in United Kingdom.
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 3 inclusion and 5 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 16 Jan 2019. 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 Kingdom. 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. 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?
Endothelial (dys)function (time frame: 2 hours post-prandial). 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 16 Jan 2019.