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

NCT03806829 | Completed

• 1 other identifier: ETHSHE1376
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Dysfunction

Keywords

antioxidants; polyphenols; flow-mediated dilatation

Outcome Measures

Primary Outcomes (1)

• Endothelial (dys)function

  Assessed via flow mediated dilatation

  2 hours post-prandial

Secondary Outcomes (3)

• Plasma Nitrite

  2 hours post-prandial

• Plasma antioxidant capacity

  2 hours post-prandial

• Plasma ox-LDL

  2 hours post-prandial

Study Arms (4)

Water + Meal

ACTIVE COMPARATOR

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

Other: Water

Red Wine + Meal

EXPERIMENTAL

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

Other: Red Wine

Green Tea + Meal

EXPERIMENTAL

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

Other: Green Tea

Orange Juice + Meal

EXPERIMENTAL

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

Other: Orange Juice

Interventions

Water OTHER

250 ml

Water + Meal

Red Wine OTHER

250 ml

Red Wine + Meal

Green Tea OTHER

250 ml

Green Tea + Meal

Orange Juice OTHER

250 ml

Orange Juice + Meal

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Highlands and Islands: lead

Study Sites (1)

University of the Highlands and Islands

Inverness, IV2 3JH, United Kingdom

Location

MeSH Terms

Interventions

Water; Tea

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ian Megson, Megson

  University of the Highlands and Islands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: June 6, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)