The Acute Effects of Commercially Available Drinks on the Endothelial Function of Humans Following a High-fat Meal

NCT ID: NCT03806829

Last Updated: 2019-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-06

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Water + Meal

250 ml Water and a high calorie, high fat meal (\>900 kcal, 50g fat)

Group Type ACTIVE_COMPARATOR

Water

Intervention Type OTHER

250 ml

Red Wine + Meal

250 ml Red Wine and a high calorie, high fat meal (\>900 kcal, 50g fat)

Group Type EXPERIMENTAL

Red Wine

Intervention Type OTHER

250 ml

Green Tea + Meal

250 ml Green Tea and a high calorie, high fat meal (\>900 kcal, 50g fat)

Group Type EXPERIMENTAL

Green Tea

Intervention Type OTHER

250 ml

Orange Juice + Meal

250 ml Orange Juice and a high calorie, high fat meal (\>900 kcal, 50g fat)

Group Type EXPERIMENTAL

Orange Juice

Intervention Type OTHER

250 ml

Interventions

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Water

250 ml

Intervention Type OTHER

Red Wine

250 ml

Intervention Type OTHER

Green Tea

250 ml

Intervention Type OTHER

Orange Juice

250 ml

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Females to be postmenopausal and not on hormone replacement therapy
* 25 \> BMI \< 35
* Sedentary to light activity lifestyle.

Exclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of the Highlands and Islands

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian Megson, Megson

Role: PRINCIPAL_INVESTIGATOR

University of the Highlands and Islands

Locations

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University of the Highlands and Islands

Inverness, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ETHSHE1376

Identifier Type: -

Identifier Source: org_study_id

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