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

January 14, 2019 updated by: University of the Highlands and Islands

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Inverness, United Kingdom, IV2 3JH
        • University of the Highlands and Islands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Water + Meal
250 ml Water and a high calorie, high fat meal (>900 kcal, 50g fat)
Other: Water
250 ml
Experimental: Red Wine + Meal
250 ml Red Wine and a high calorie, high fat meal (>900 kcal, 50g fat)
Other: Red Wine
250 ml
Experimental: Green Tea + Meal
250 ml Green Tea and a high calorie, high fat meal (>900 kcal, 50g fat)
Other: Green Tea
250 ml
Experimental: Orange Juice + Meal
250 ml Orange Juice and a high calorie, high fat meal (>900 kcal, 50g fat)
Other: Orange Juice
250 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial (dys)function
Time Frame: 2 hours post-prandial
Assessed via flow mediated dilatation
2 hours post-prandial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Nitrite
Time Frame: 2 hours post-prandial
2 hours post-prandial
Plasma antioxidant capacity
Time Frame: 2 hours post-prandial
Plasma oxygen radical absorbance capacity
2 hours post-prandial
Plasma ox-LDL
Time Frame: 2 hours post-prandial
2 hours post-prandial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Highlands and Islands

Investigators

  • Principal Investigator: Ian Megson, Megson, University of the Highlands and Islands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2018

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

July 31, 2018

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ETHSHE1376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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