Ignite Creation Date:
2024-05-06 @ 3:47 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02379403
Status:
WITHDRAWN
Last Update Posted:
2017-10-06
First Post:
2015-03-04
Brief Title:
Effects of Tart Cherry and Aroniaberry Supplementation on Endothelial Function and Cardiovascular Measures in Healthy Older Adults Interactions With Genotype and Proteome
Sponsor:
National Institute of Nursing Research NINR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Tart Cherry and Aroniaberry Supplementation on Endothelial Function and Cardiovascular Measures in Healthy Older AdultsInteractions With Genotype and Proteome
Status:
WITHDRAWN
Status Verified Date:
2017-05-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-NR-0085 | None | None | None |