Effects of Tart Cherry and Aroniaberry Supplementation on Endothelial Function and Cardiovascular Measures in Healthy Older Adults: Interactions With Genotype and Proteome
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
| Healthy: | No |
| Age Range: | 55 - 70 |
| Updated: | 4/22/2017 |
| Start Date: | February 19, 2015 |
| End Date: | March 1, 2019 |
| Contact: | Karen Taylor, R.N. |
| Email: | karen.taylor2@nih.gov |
| Phone: | (301) 451-5952 |
Effects of Tart Cherry and Aroniaberry Supplementation on Endothelial Function and Cardiovascular Measures in Healthy Older Adults:Interactions With Genotype and Proteome
Background:
- Heart disease is the leading cause of death and disabilities in the United States. Diets
high in fruits and vegetables may reduce the risk of heart disease. Fruits, including red
tart cherries and purple aroniaberries, may be especially beneficial. Researchers want to
know how tart cherry and aroniaberry extracts affect heart health.
Objective:
- To study the benefits of tart cherry and aroniaberry extract on vascular function and
other measures. These include inflammation, oxidation, and cholesterol.
Eligibility:
- Men and post-menopausal women ages 55 70 in good health and with normal or slightly high
blood pressure or cholesterol.
Design:
- Participants will be screened with a physical exam, medical history, and blood tests.
- Participants will have 6 visits. They will have blood taken at every visit.
- Visit 1:
- Blood vessel tests. Participants will lie down. Heart rhythm will be monitored. A
device will be placed on the upper arm, and pictures of blood vessels will be taken.
- A blood pressure cuff will be tightened around the lower arm for 5 minutes.
- Cardio-Ankle-Vascular Index (CAVI). Blood pressure cuffs will be placed on both arms
and legs. They will be tightened with air at the same time for a few minutes.
- Participants will be assigned to one of three groups. For 3 weeks each, in random
order, they will take: aroniaberry capsules, tart cherry capsules, placebo capsules,
and no capsules.
- Participants will answer questions online about their eating and exercise.
- Participants will be keep a record of what they eat for a few periods. They will come
for a study visit every 3 weeks through week 15.
- Heart disease is the leading cause of death and disabilities in the United States. Diets
high in fruits and vegetables may reduce the risk of heart disease. Fruits, including red
tart cherries and purple aroniaberries, may be especially beneficial. Researchers want to
know how tart cherry and aroniaberry extracts affect heart health.
Objective:
- To study the benefits of tart cherry and aroniaberry extract on vascular function and
other measures. These include inflammation, oxidation, and cholesterol.
Eligibility:
- Men and post-menopausal women ages 55 70 in good health and with normal or slightly high
blood pressure or cholesterol.
Design:
- Participants will be screened with a physical exam, medical history, and blood tests.
- Participants will have 6 visits. They will have blood taken at every visit.
- Visit 1:
- Blood vessel tests. Participants will lie down. Heart rhythm will be monitored. A
device will be placed on the upper arm, and pictures of blood vessels will be taken.
- A blood pressure cuff will be tightened around the lower arm for 5 minutes.
- Cardio-Ankle-Vascular Index (CAVI). Blood pressure cuffs will be placed on both arms
and legs. They will be tightened with air at the same time for a few minutes.
- Participants will be assigned to one of three groups. For 3 weeks each, in random
order, they will take: aroniaberry capsules, tart cherry capsules, placebo capsules,
and no capsules.
- Participants will answer questions online about their eating and exercise.
- Participants will be keep a record of what they eat for a few periods. They will come
for a study visit every 3 weeks through week 15.
Cardiovascular disease (CVD) continues to be the leading cause of death and disability
worldwide. Cardiovascular disease can be age-related in both onset and progression. The
aging process causes failure in protective vascular mechanisms leading to pathophysiological
changes and increased risk of CVD. Heart healthy strategies including consumption of diets
rich in fruits and vegetables reduce risk and prevent CVD. There is growing experimental
evidence that certain fruits and berries including, cherries and aroniaberries, may be
cardioprotective due to their antioxidant and vasodilatory properties, and beneficial
modulation of immune function and inflammation. However, there are limited human studies
that have examined these effects. In older adults, vascular aging predominantly includes
increased arterial stiffness and endothelial dysfunction. Oxidative stress and inflammation
are also linked to the aging process. Therefore, this study will investigate the effects of
tart cherry and aroniaberry supplementation on endothelial function (flow-mediated brachial
artery dilation) and arterial stiffness (cardio-ankle vascular index) as indicators of
cardiovascular risk and atherosclerosis. These measurements also provide an assessment of
arterial structure and function. Biomarkers of endothelial dysfunction, inflammation,
vascular injury, oxidation, lipids, as well as flavonoid and phenolic acid profiles will
also be examined. Importantly, the role of genetics and its environmental interactions as
causal factors in CVD are not completely understood. There is also limited data on the
plasma proteome and the changes in physiological processes that may result from
interventions with diet or nutrients. This study will explore the association between
responses to tart cherry or aroniaberry supplementation and single nucleotide polymorphisms
(SNPs) in loci related to the study s outcomes and to the risk of CVD. Moreover, the
association between these two supplements and a proteomic panel of plasma proteins involved
in several physiological pathways and CVD will also be investigated. In a randomized,
double-blind, placebo-controlled, crossover clinical trial, 96 healthy older adults (ages
55-70) will be given tart cherry alternating with aroniaberry supplementation daily for 3
weeks each while on their usual diet. This study will include an initial screening visit
followed by 6 visits at 3 week intervals consisting of treatment, washout and placebo
periods. This investigation will provide important information on the role of flavonoidrich
nutrients and their effect on arterial structure and function. Relating genomic and
proteomic signatures to the outcomes of this study will be useful in developing future
therapeutic strategies to lower CVD risk.
worldwide. Cardiovascular disease can be age-related in both onset and progression. The
aging process causes failure in protective vascular mechanisms leading to pathophysiological
changes and increased risk of CVD. Heart healthy strategies including consumption of diets
rich in fruits and vegetables reduce risk and prevent CVD. There is growing experimental
evidence that certain fruits and berries including, cherries and aroniaberries, may be
cardioprotective due to their antioxidant and vasodilatory properties, and beneficial
modulation of immune function and inflammation. However, there are limited human studies
that have examined these effects. In older adults, vascular aging predominantly includes
increased arterial stiffness and endothelial dysfunction. Oxidative stress and inflammation
are also linked to the aging process. Therefore, this study will investigate the effects of
tart cherry and aroniaberry supplementation on endothelial function (flow-mediated brachial
artery dilation) and arterial stiffness (cardio-ankle vascular index) as indicators of
cardiovascular risk and atherosclerosis. These measurements also provide an assessment of
arterial structure and function. Biomarkers of endothelial dysfunction, inflammation,
vascular injury, oxidation, lipids, as well as flavonoid and phenolic acid profiles will
also be examined. Importantly, the role of genetics and its environmental interactions as
causal factors in CVD are not completely understood. There is also limited data on the
plasma proteome and the changes in physiological processes that may result from
interventions with diet or nutrients. This study will explore the association between
responses to tart cherry or aroniaberry supplementation and single nucleotide polymorphisms
(SNPs) in loci related to the study s outcomes and to the risk of CVD. Moreover, the
association between these two supplements and a proteomic panel of plasma proteins involved
in several physiological pathways and CVD will also be investigated. In a randomized,
double-blind, placebo-controlled, crossover clinical trial, 96 healthy older adults (ages
55-70) will be given tart cherry alternating with aroniaberry supplementation daily for 3
weeks each while on their usual diet. This study will include an initial screening visit
followed by 6 visits at 3 week intervals consisting of treatment, washout and placebo
periods. This investigation will provide important information on the role of flavonoidrich
nutrients and their effect on arterial structure and function. Relating genomic and
proteomic signatures to the outcomes of this study will be useful in developing future
therapeutic strategies to lower CVD risk.
- INCLUSION CRITERIA:
An Associate Investigator will examine participants and determine their eligibility
according to the inclusion and exclusion criteria as documented by the eligibility
checklist.
- Men and women between the ages 55-70 years
- In good general health as determined by physical exam and normal ranges obtained
during screening
- Post-menopausal women (no menses within 12 months)
- Normal or pre-hypertensive blood pressure (e.g., SBP less than or equal to 139 mmHg
and DBP less than or equal to 89 mmHg)
- Normal or mild hyperlipidemia (e.g., TC less than or equal to 239, LDL less than or
equal to159, Triglycerides less than or equal to 199, HDL <45 mg/dL)
- BMI between 18.5 to 25kg/m2
- Willing and ability to sign consent
- Willing to make time commitment for study
- Individuals who are fluent in English
EXCLUSION CRITERIA:
- Progressive or unstable known disease of any body system including cardiovascular,
pulmonary, gastrointestinal, central nervous system, psychiatric, endocrine,
hematologic, renal, or immunologic disorders
- Known acute and chronic inflammatory disease (i.e. rheumatoid arthritis, systemic
lupus erythematous, hepatitis)
- Elevated C-reactive protein level (>3.0mg/L)
- Current (or within the last 3 months) smoking of any tobacco products, i.e.,
cigarettes, pipe
- Abnormal Complete Metabolic Panel (CMP), Complete Blood Count (CBC), cholesterol
panel, Thyroid Stimulating Hormone (TSH), Erythrocyte Sedimentation Rate (ESR) --
(laboratory values outside of acceptable reference range for older adults if
determined to
be clinically significant)
- Indications of current or within last 3 years substance or alcohol abuse
- Alcohol consumption >1 drink/day, i.e., 1 bottle of beer, half glass of wine, 1 shot
hard liquor
- Known sensitivity or allergy to tart cherry or aroniaberry
- Currently on cholesterol-lowering, anti-hypertensive, thyroid, steroid or hormonal
medications
- Routine use of vitamins, supplements, or over the counter medications including
aspirin, aspirin-containing products, non-steroidal anti-inflammatory drugs (NSAIDs),
i.e., motrin, advil, aleve, unless they were discontinued 14 days prior to their
first visit.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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