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Clinical Trials/NCT01557738
NCT01557738CompletedNot Applicable

Acute and Long-term Effects of Dietary Flavanols on Local Control of Skeletal Muscle Blood Flow During Exercise in Young and Old Humans

University of Texas at Austin1 site in 1 country20 target enrollmentStarted: December 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Change in femoral blood flow during exercise following flavanol consumption

Study Overview

Brief Summary

It has well known that diets rich in fruits, vegetables and cocoa products are associated with positive health benefits and these positive effects have been shown to be due to compounds they contain called flavanols. Flavanols have been shown to exert their positive effects by indirectly increasing nitric oxide (NO) bioavailability. NO is a potent vasodilator that is believed to play a role in increasing blood flow to active muscle during exercise. This regulatory process is impaired with healthy aging. The underlying premise to this study is that if NO bioavailability can be increased following flavanol ingestion, will there be a restoration of blood flow during exercise in older individuals? Accordingly, the first part of this research project will compare the acute vascular effects of flavanol ingestion between a young and old group. The investigators have hypothesized that both groups will show an improvement in blood flow to active muscle during exercise, though the magnitude of the change will be greater in the older group. The second part of this project will look at the effects of 4 weeks of daily flavanol ingestion in the old group. The investigators hypothesize that subjects will demonstrate an improvement in blood flow to active muscle during exercise after the 4 week intervention and that the magnitude of the change will be greater than the acute effects. Findings from this proposal will provide evidence for the efficacy of flavanols to be used (as a simple and safe lifestyle intervention) to reverse or combat impaired blood flow regulation in older individuals.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Males and Females between 18 - 30 years old
  • •Males and Females between 60 - 80 years old

Exclusion Criteria

  • •cardiovascular and/or microvascular disease
  • •blood clotting disorder
  • •pregnant lady
  • •current smoker (or regularly smoked within last year)
  • •a history of an adverse reaction to cold
  • •taking medications known to effect the autonomic nervous system

Arms & Interventions

Acute effects of flavanol consumption

Experimental

The outcome measurements will be made on all study participants before and 2 hours after consumption of the high flavanol beverage.

Intervention: High Flavanol Trial (Dietary Supplement)

Low Flavanol Trial; acute effects

Placebo Comparator

Once again, the outcome measurements will be made on all study participants before and 2 hours after consumption of the low flavanol beverage.

Intervention: Low Flavanol Trial (Dietary Supplement)

Long-term effects of flavanol consumption

Experimental

Only those study participants over 60 years of age will continue with this arm of the trial. The same outcome measures will be performed following 4 weeks of daily consumption of a high flavanol beverage.

Intervention: High Flavanol Trial; long-term (Dietary Supplement)

Low Flavanol Trial; long-term effects

Placebo Comparator

Only those study participants over 60 years of age will continue with this arm of the trial. The same outcome measures will be performed following 4 weeks of daily consumption of a low flavanol beverage.

Intervention: Low Flavanol Trial; long-term effects (Dietary Supplement)

Outcomes

Primary Outcomes

Change in femoral blood flow during exercise following flavanol consumption

Time Frame: During knee extension exercise, change from baseline in blood flow 2 hours post flavanol ingestion

Blood flow regulation to active muscles during knee extension exercise can be assessed by using ultrasound to measure blood flow in the femoral artery. This will be done before and after stimulation of the sympathetic nervous system. A baseline value will be obtained and then the measurement will be performed again 2 hours after flavanol ingestion.

Secondary Outcomes

  • Change in flow-mediated dilation (FMD) following flavanol consumption(Change from baseline in FMD 2 hours post flavanol ingestion)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Robert M. Brothers

Assistant Professor

University of Texas at Austin

Study Sites (1)

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