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Clinical Trials/NCT03806829
NCT03806829CompletedNot Applicable

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

University of the Highlands and Islands2 sites in 1 country7 target enrollmentStarted: June 6, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
7
Locations
2
Primary Endpoint
Endothelial (dys)function

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
50 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Red Wine + Meal

Experimental

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

Intervention: Red Wine (Other)

Orange Juice + Meal

Experimental

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

Intervention: Orange Juice (Other)

Water + Meal

Active Comparator

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

Intervention: Water (Other)

Green Tea + Meal

Experimental

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

Intervention: Green Tea (Other)

Outcomes

Primary Outcomes

Endothelial (dys)function

Time Frame: 2 hours post-prandial

Assessed via flow mediated dilatation

Secondary Outcomes

  • Plasma antioxidant capacity(2 hours post-prandial)
  • Plasma ox-LDL(2 hours post-prandial)
  • Plasma Nitrite(2 hours post-prandial)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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