Role of Flavanols in Exercise and Aging

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.

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

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Dietary Supplement: High Flavanol Trial
* Dietary Supplement: Low Flavanol Trial
* Dietary Supplement: High Flavanol Trial; long-term
* Dietary Supplement: Low Flavanol Trial; long-term effects


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute effects of flavanol consumption<br>The outcome measurements will be made on all study participants before and 2 hours after consumption of the high flavanol beverage. | Dietary Supplement: High Flavanol Trial<br>* The experimental trial (high flavanol content) will involve the consumption of a beverage containing about 1000mg of cocoa flavanols.<br>|
| Placebo Comparator: Low Flavanol Trial; acute effects<br>Once again, the outcome measurements will be made on all study participants before and 2 hours after consumption of the low flavanol beverage. | Dietary Supplement: Low Flavanol Trial<br>* The placebo trial (low flavanol content) will involve the consumption of a beverage containing 75 mg of cocoa flavanols.<br>|
| Experimental: Long-term effects of flavanol consumption<br>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. | Dietary Supplement: High Flavanol Trial; long-term<br>* 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.<br>|
| Placebo Comparator: Low Flavanol Trial; long-term effects<br>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. | Dietary Supplement: Low Flavanol Trial; long-term effects<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in femoral blood flow during exercise following flavanol consumption | 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. | During knee extension exercise, change from baseline in blood flow 2 hours post flavanol ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in flow-mediated dilation (FMD) following flavanol consumption | 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. | Change from baseline in FMD 2 hours post flavanol ingestion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Blood Flow, Nitric Oxide, Aging, Antioxidant, Flavanol, Young (18-30 yrs), Aging (60 - 80 yrs)