AgingNCT01557738
Role of Flavanols in Exercise and Aging
A study testing High Flavanol Trial, Low Flavanol Trial and High Flavanol Trial; long-term in people with Aging, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- High Flavanol Trial, Low Flavanol Trial and High Flavanol Trial; long-term
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and Females between 18 - 30 years old
- Males and Females between 60 - 80 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Austin: Environmental and Autonomic Physiology Laboratory
Austin, Texas, 78712
About this study
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
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
- Being tested
- High Flavanol Trial, Low Flavanol Trial, High Flavanol Trial; long-term, Low Flavanol Trial; long-term effects
- Keywords
- Exercise, Blood Flow, Nitric Oxide, Aging, Antioxidant, Flavanol, Young (18-30 yrs), Aging (60 - 80 yrs)
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flavanol TrialDietary supplement
The experimental trial (high flavanol content) will involve the consumption of a beverage containing about 1000mg of cocoa flavanols.
Low Flavanol TrialDietary supplement
The placebo trial (low flavanol content) will involve the consumption of a beverage containing 75 mg of cocoa flavanols.
High Flavanol Trial; long-termDietary 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 effectsDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: High Flavanol Trial |
| 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. Receives: Dietary Supplement: Low Flavanol Trial |
| 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. Receives: Dietary Supplement: High Flavanol Trial; long-term |
| 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. Receives: Dietary Supplement: Low Flavanol Trial; long-term effects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During knee extension exercise, change from baseline in blood flow 2 hours post flavanol ingestion
Secondary outcomes (1)
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.
Measured: Change from baseline in FMD 2 hours post flavanol ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert M. Brothers, University of Texas at Austin
- Investigators
- Michelle Harrison, M.A., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557738
- Sponsor's protocol ID
- 2012-02-0114
- Status last verified
- May 2014
- First submitted
- 8 Mar 2012
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01557738
- Acronym / sponsor ID
- 2012-02-0114
- Conditions
- Aging
- Keywords
- Exercise, Blood Flow, Nitric Oxide, Aging, Antioxidant, Flavanol, Young (18-30 yrs), Aging (60 - 80 yrs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute effects of flavanol consumption | Experimental | Dietary Supplement: High Flavanol TrialThe outcome measurements will be made on all study participants before and 2 hours after consumption of the high flavanol beverage. |
| Low Flavanol Trial; acute effects | Placebo comparator | Dietary Supplement: Low Flavanol TrialOnce again, the outcome measurements will be made on all study participants before and 2 hours after consumption of the low flavanol beverage. |
| Long-term effects of flavanol consumption | Experimental | Dietary Supplement: High Flavanol Trial; long-termOnly 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. |
| Low Flavanol Trial; long-term effects | Placebo comparator | Dietary Supplement: Low Flavanol Trial; long-term effectsOnly 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and Females between 18 - 30 years old
- Males and Females between 60 - 80 years old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flavanol TrialThe experimental trial (high flavanol content) will involve the consumption of a beverage containing about 1000mg of cocoa flavanols. | Dietary supplement | Acute effects of flavanol consumption |
| Low Flavanol TrialThe placebo trial (low flavanol content) will involve the consumption of a beverage containing 75 mg of cocoa flavanols. | Dietary supplement | Low Flavanol Trial; acute effects |
| High Flavanol Trial; long-termThe 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. | Dietary supplement | Long-term effects of flavanol consumption |
| Low Flavanol Trial; long-term effectsThe 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. | Dietary supplement | Low Flavanol Trial; long-term effects |
Primary outcome
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.
1 secondary outcome
Change in flow-mediated dilation (FMD) following flavanol consumption
Time frame: Change from baseline in FMD 2 hours post flavanol ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
Related trials for Aging
Recruiting
Feasibility of A Smartphone Application Intervention in Community Settings: A Pretest-Posttest Pilot Study
Aging, Dementia
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Plant-based Diet in Older People: What Consequences for Muscle Health?
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Harrison, M.A. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flavanol Trial, Low Flavanol Trial and High Flavanol Trial; long-term in people with Aging, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2014.