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AzTrials

Cardiovascular DiseaseNCT02379403

Effects of Tart Cherry and Aroniaberry Supplementation on Endothelial Function and Cardiovascular Measures in Healthy Older Adults: Interactions With Genotype and Proteome

An observational study of Cardiovascular Disease and Coronary Heart Disease, run by National Institute of Nursing Research (NINR).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 70 yearsHealthy volunteers can take part
How many people
0 participants
Where
No sites listed yet
Study dates
19 Feb 2015to 9 May 2017
Phase
Observational
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 55 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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.

About this study

Official title: 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.
Read more

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.
Read the 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.

Keywords
Flavonoid, Vascular, Biomarkers, Arterial Stiffness, Nutrigenomics
Medical subject headings
Cardiovascular Diseases, Coronary Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endothelial Function

    Measured: Every 3 weeks over 15 weeks

Secondary outcomes (3)

  1. Arterial stiffness, biomarkers of endothelial dysfunction, inflammation, vascular injury, oxidation, lipids, nitric oxide status, flavonoid and phenolic acid profiles.

    Measured: Every 3 weeks over 15 weeks

  2. Proteomic panel of plasma proteins

    Measured: Every 3 weeks over 15 weeks

  3. Nutrigenomics

    Measured: Every 3 weeks over 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2015 (estimated)
  2. Study start19 Feb 2015
  3. Primary completion9 May 2017
  4. Study completion9 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02379403
Sponsor's protocol ID
150085
Other IDs
15-NR-0085
Status last verified
9 May 2017
First submitted
4 Mar 2015
Last updated
6 Oct 2017
Results posted
No

Publications

  • Engler MB, Engler MM, Chen CY, Malloy MJ, Browne A, Chiu EY, Kwak HK, Milbury P, Paul SM, Blumberg J, Mietus-Snyder ML. Flavonoid-rich dark chocolate improves endothelial function and increases plasma epicatechin concentrations in healthy adults. J Am Coll Nutr. 2004 Jun;23(3):197-204. doi: 10.1080/07315724.2004.10719361.

    PubMed 15190043

  • Tresserra-Rimbau A, Rimm EB, Medina-Remon A, Martinez-Gonzalez MA, de la Torre R, Corella D, Salas-Salvado J, Gomez-Gracia E, Lapetra J, Aros F, Fiol M, Ros E, Serra-Majem L, Pinto X, Saez GT, Basora J, Sorli JV, Martinez JA, Vinyoles E, Ruiz-Gutierrez V, Estruch R, Lamuela-Raventos RM; PREDIMED Study Investigators. Inverse association between habitual polyphenol intake and incidence of cardiovascular events in the PREDIMED study. Nutr Metab Cardiovasc Dis. 2014 Jun;24(6):639-47. doi: 10.1016/j.numecd.2013.12.014. Epub 2014 Jan 22.

    PubMed 24552647

  • Ungvari Z, Kaley G, de Cabo R, Sonntag WE, Csiszar A. Mechanisms of vascular aging: new perspectives. J Gerontol A Biol Sci Med Sci. 2010 Oct;65(10):1028-41. doi: 10.1093/gerona/glq113. Epub 2010 Jun 24.

    PubMed 20576649

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Disease and Coronary Heart Disease, run by National Institute of Nursing Research (NINR).

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 10 inclusion and 11 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: withdrawn, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.

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?

Endothelial Function (time frame: Every 3 weeks over 15 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02379403, which also lists 3 linked publications.

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 6 Oct 2017.

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