Effects of Resveratrol Supplements on Vascular Health in Postmenopausal Women
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 50 - 70 |
| Updated: | 7/15/2017 |
| Start Date: | March 2012 |
| End Date: | March 2015 |
The investigators hope to learn if resveratrol supplementation can be beneficial for the
cardiovascular system. Seeing that resveratrol is rapidly metabolized, the investigators are
interested in learning if a novel form of resveratrol, ResA, which is a mixture of
resveratrol with amino acid, may have greater bioavailability and lead to greater improvement
in vascular function, compared to standard resveratrol supplement.
cardiovascular system. Seeing that resveratrol is rapidly metabolized, the investigators are
interested in learning if a novel form of resveratrol, ResA, which is a mixture of
resveratrol with amino acid, may have greater bioavailability and lead to greater improvement
in vascular function, compared to standard resveratrol supplement.
Cardiovascular disease is the leading cause of morbidity and mortality in the United States.
To reduce the risk of cardiovascular disease (CVD) and its associated health care costs,
nutrition and health recommendations strongly advocate the consumption of a diet rich in
fruits and vegetables. In addition to essential vitamins and minerals, fruits and vegetables
contain a number of bioactive compounds that may be involved in vascular function.
The "French Paradox" refers to diet patterns that, despite being high in saturated fat, are
associated with a relatively low cardiovascular risk. An important aspect of many of the
diets that were identified in the French Paradox studies is a significant intake of wine,
particularly red wine, which can contain an array of phytochemicals that have been postulated
to improve cardiovascular health. A polyphenolic that has received particular attention is
this regard is resveratrol.
The stilbene resveratrol is found predominately in red grapes, red wine, peanuts and some
berries, and it has been touted in the popular press for its potential health-promoting
benefits. Emerging evidence suggests a role for resveratrol in the protection against
numerous degenerative health problems including CVD and certain cancers, diabetes and some
forms of neurodegeneration.
The amount of resveratrol in most foods is very low; thus obtaining the amounts of this
compound that have been associated with improved health in animal models is difficult for
humans. ResA is a product produced using patented technology that physically binds
resveratrol to arginine, creating a novel conjugate. In the preliminary studies the ResA
conjugate produced higher peak plasma levels, as well as total plasma levels that persist for
a longer period of time when fed to rats. Whether similar results would occur in humans, and
the extent to which increasing blood resveratrol concentration can be associated with
positive cardiovascular effects in an at-risk population is the subject of this project.
To reduce the risk of cardiovascular disease (CVD) and its associated health care costs,
nutrition and health recommendations strongly advocate the consumption of a diet rich in
fruits and vegetables. In addition to essential vitamins and minerals, fruits and vegetables
contain a number of bioactive compounds that may be involved in vascular function.
The "French Paradox" refers to diet patterns that, despite being high in saturated fat, are
associated with a relatively low cardiovascular risk. An important aspect of many of the
diets that were identified in the French Paradox studies is a significant intake of wine,
particularly red wine, which can contain an array of phytochemicals that have been postulated
to improve cardiovascular health. A polyphenolic that has received particular attention is
this regard is resveratrol.
The stilbene resveratrol is found predominately in red grapes, red wine, peanuts and some
berries, and it has been touted in the popular press for its potential health-promoting
benefits. Emerging evidence suggests a role for resveratrol in the protection against
numerous degenerative health problems including CVD and certain cancers, diabetes and some
forms of neurodegeneration.
The amount of resveratrol in most foods is very low; thus obtaining the amounts of this
compound that have been associated with improved health in animal models is difficult for
humans. ResA is a product produced using patented technology that physically binds
resveratrol to arginine, creating a novel conjugate. In the preliminary studies the ResA
conjugate produced higher peak plasma levels, as well as total plasma levels that persist for
a longer period of time when fed to rats. Whether similar results would occur in humans, and
the extent to which increasing blood resveratrol concentration can be associated with
positive cardiovascular effects in an at-risk population is the subject of this project.
Inclusion Criteria:
- 50 to 70 years of age
- Lack of menses in the last year and FSH 23-116.3 mlU/mL
- Subject is willing and able to comply with the study protocols.
- Subject is willing to consume resveratrol supplements/placebo capsules on three
separate occasions.
- BMI 18.5-34.9 kg/m2
- Weight ≥ 110 pounds
- LDL-C ≥ 130 mg/dL
Exclusion Criteria:
- BMI ≥ 35 kg/m2
- Self reported use of anticoagulation agents including NSAIDs
- Self reported use of oral cortisone or other immunosuppressive agents,
- Self reported underlying neoplasia or immunological disease
- Food faddists or those taking a non-traditional diet
- Self reported physical activity restricted or reduced due to chronic health conditions
- Self reported diabetes
- Blood pressure ≥ 140/90 mm Hg
- PFA-100 readings 10 % outside of normal reference range (normal reference range for
ADP-Collagen: 71-118 sec; Epinephrine-Collagen: 94-193 sec).
- Self reported renal or liver disease
- Self reported heart disease, which includes cardiovascular events and stroke
- Self reported Cushing's syndrome
- Self reported chronic/routine high intensity exercise
- Inability to properly place or wear the PAT probes or abnormal measurements on
pre-screening PAT
- Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference
range) if determined to be clinically significant.
- Self reported cancer within past 5 years
- Self reported history of psychiatric disorders i.e. schizophrenia or bi-polar or
depression treated with antidepressants within the last 1 year.
- Self reported use of MAOI inhibitor within the last 1 year (e.g. phenelzine (Nardil),
tranylcypromine (Parnate), etc)
- Self reported malabsorption (e.g. difficulty digesting or absorbing nutrients from
food,
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