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

Endothelial Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03806829
• Other study ID #: ETHSHE1376
• Status: Completed
• Phase: N/A
• Start date: June 6, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: January 2019
• Source: University of the Highlands and Islands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Other:
• Water
250 ml
• Red Wine
250 ml
• Green Tea
250 ml
• Orange Juice
250 ml

Locations

Country	Name	City	State
United Kingdom	University of the Highlands and Islands	Inverness

Sponsors (1)

Lead Sponsor	Collaborator
University of the Highlands and Islands

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial (dys)function	Assessed via flow mediated dilatation	2 hours post-prandial
Secondary	Plasma Nitrite		2 hours post-prandial
Secondary	Plasma antioxidant capacity	Plasma oxygen radical absorbance capacity	2 hours post-prandial
Secondary	Plasma ox-LDL		2 hours post-prandial