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OpenTrials
Completed

NCT Number: NCT01557738

Role of Flavanols in Exercise and Aging

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at Austin: Environmental and Autonomic Physiology Laboratory

Austin, Texas, 78712, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Flavanol Trial

Dietary Supplement

The experimental trial (high flavanol content) will involve the consumption of a beverage containing about 1000mg of cocoa flavanols.

Low Flavanol Trial

Dietary Supplement

The placebo trial (low flavanol content) will involve the consumption of a beverage containing 75 mg of cocoa flavanols.

High Flavanol Trial; long-term

Dietary Supplement

The experimental trial (high flavanol content) will involve the daily consumption of a beverage containing about 1000mg of cocoa flavanols for 4 weeks. Subjects will be provided with 28 packets of the beverage to take home with them.

Low Flavanol Trial; long-term effects

Dietary Supplement

The placebo trial (low flavanol content) will involve the daily consumption of a beverage containing 75 mg of cocoa flavanols for 4 weeks. Subjects will be provided with 28 packets to take home with them.

Primary outcomes

  1. 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

  1. Change in flow-mediated dilation (FMD) following flavanol consumption

    Time frame: Change from baseline in FMD 2 hours post flavanol ingestion

    Flow-mediated dilation is commonly used as an index of nitric oxide bioavailability. Nitric oxide is believed to play a role in blood flow regulation during exercise. A baseline value will be obtained and then the measurement will be performed again 2 hours after flavanol ingestion.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 19, 2012
Registry last updated
Jun 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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