Role of Flavanols In Cardiovascular Function in Healthy Aging

NCT01395277 | Completed Results

• 1 other identifier: 2011-05-0029
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Groups of naturally occurring compounds called flavonoids are found in foods such as fruits and vegetables, red wine, tea, dark chocolate and cocoa products. Diets rich in flavonoids are associated with decreased risk for cardiovascular disease and major cardiovascular events (i.e. myocardial infarction) and have been shown to improve blood pressure, insulin sensitivity, and vascular function in a variety populations (Type II diabetes, elderly, smokers, etc.). The presumed beneficial effects of these compounds are thought to act through their inherent ability to scavenge free radicals. Specifically flavonoids scavenge superoxide anions which are free radicals that react with nitric oxide (NO) to produce peroxynitrite. The formation of peroxynitrite ultimately reduces the bioavailability of NO which is essential for vasodilation and thus vascular health and function. Normal aging is associated with impaired endothelial function, which presumably is due to less than optimal levels of NO bioavailability. Therefore, interventions that can increase NO bioavailability would be expected to improve microvascular function and vascular health in this population. The purpose of this study is to investigate the effects of dietary flavonoid supplementation on the vasodilatory capacity of the cutaneous vasculature, as well as on cerebral vascular reactivity and arterial stiffness in young and old humans. This study will test the hypothesis that acute dietary flavonoid treatment will improve impaired cutaneous vasodilatory capacity, cerebral vasomotor reactivity, and reduce arterial stiffness in older but not young humans.

Conditions

Aging

Keywords

Nitric Oxide; Vascular Function; Aging; Blood Pressure; Arterial Stiffness; Cardiovascular Disease; Cerebral Blood Flow

Outcome Measures

Primary Outcomes (1)

• Cutaneous Blood Flow Response to Local Heating of the Skin.

  Local heating of the cutaneous vasculature to 42 degree C is commonly used to evoke a maximal skin blood flow response (only at the site of local heating). This response is almost entirely dependent on nitric oxide mediated vasodilation.

  prior to (baseline) and 2 hours post beverage consumption

Secondary Outcomes (1)

• Pulse Wave Velocity / Arterial Stiffness

  Prior to (baseline) and 2 hours following beverage consumption

Study Arms (2)

High Flavanol first then Low Flavanol

EXPERIMENTAL

The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with "high" flavanol content and 2) before and 2 hours following consumption of a beverage with "low" flavanol content.

Dietary Supplement: High Flavanol first then Low Flavanol

Low Flavanol first then High Flavanol

EXPERIMENTAL

The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with "low" flavanol content and 2) before and 2 hours following consumption of a beverage with "high" flavanol content.

Dietary Supplement: Low Flavanol first then High Flavanol

Interventions

High Flavanol first then Low Flavanol DIETARY_SUPPLEMENT

The high flavanol trial will be performed following consumption of a beverage containing 1,050 mg of commercially available Cocoa Flavanols which will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol trial will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols which will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.

Also known as: dark chocolate beverage

High Flavanol first then Low Flavanol

Low Flavanol first then High Flavanol DIETARY_SUPPLEMENT

The low flavanol trial will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols which will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The high flavanol trial will be performed following consumption of a beverage containing 1,050 mg of commercially available Cocoa Flavanols which will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.

Also known as: chocolate, Mars Incorporated

Low Flavanol first then High Flavanol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and Females between 18 - 26 years old
• Males and Females between 65 - 80 years old

You may not qualify if:

• cardiovascular disease
• metabolic disease
• neurological disease
• Pregnant lady
• Current smoker (or regularly smoked within last year)
• Currently taking medications known to effect the autonomic nervous system

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin: Environmental and Autonomic Physiolgy Laboratory

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Chocolate

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. R. Matthew Brothers
• Organization: University of Texas at Austin

r.m.brothers@austin.utexas.edu

512-232-6016

Study Officials

• R. Matthew Brothers, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 15, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 10, 2015
• Results First Posted: August 10, 2015

Record last verified: 2015-07

Locations

US (1)