Role of Flavanols in Exercise and Aging

NCT ID: NCT01557738

Last Updated: 2014-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-04-30

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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Acute effects of flavanol consumption

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

Group Type: EXPERIMENTAL

High Flavanol Trial

Intervention Type: DIETARY_SUPPLEMENT

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

Low Flavanol Trial; acute effects

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

Group Type: PLACEBO_COMPARATOR

Low Flavanol Trial

Intervention Type: DIETARY_SUPPLEMENT

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

Long-term effects of flavanol consumption

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.

Group Type: EXPERIMENTAL

High Flavanol Trial; long-term

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Low Flavanol Trial; long-term effects

Intervention Type: 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.

Interventions

High Flavanol Trial

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

Intervention Type: DIETARY_SUPPLEMENT

Low Flavanol Trial

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

Intervention Type: DIETARY_SUPPLEMENT

High Flavanol Trial; long-term

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.

Intervention Type: DIETARY_SUPPLEMENT

Low Flavanol Trial; long-term effects

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Robert M. Brothers

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Harrison, M.A.

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

University of Texas at Austin: Environmental and Autonomic Physiology Laboratory

Austin, Texas, United States

Countries

United States

Other Identifiers

2012-02-0114

Identifier Type: -

Identifier Source: org_study_id