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OpenTrials
Completed

NCT Number: NCT03806829

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.

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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Highlands and Islands

Inverness, IV2 3JH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Water

Other

250 ml

Red Wine

Other

250 ml

Green Tea

Other

250 ml

Orange juice

Other

250 ml

Primary outcomes

  1. Endothelial (dys)function

    Time frame: 2 hours post-prandial

    Assessed via flow mediated dilatation

Secondary outcomes

  1. Plasma Nitrite

    Time frame: 2 hours post-prandial

  2. Plasma antioxidant capacity

    Time frame: 2 hours post-prandial

    Plasma oxygen radical absorbance capacity

  3. Plasma ox-LDL

    Time frame: 2 hours post-prandial

Sponsors and collaborators

Lead sponsor

University of the Highlands and Islands

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 16, 2019
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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