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

NCT02379403 | Withdrawn

• 2 other identifiers: 15008515-NR-0085
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Disease; Coronary Heart Disease; Aging

Keywords

Flavonoid; Vascular; Biomarkers; Arterial Stiffness; Nutrigenomics

Outcome Measures

Primary Outcomes (1)

• Endothelial Function

  Every 3 weeks over 15 weeks

Secondary Outcomes (3)

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

  Every 3 weeks over 15 weeks

• Proteomic panel of plasma proteins

  Every 3 weeks over 15 weeks

• Nutrigenomics

  Every 3 weeks over 15 weeks

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Related Publications (3)

• 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.

  PMID: 15190043 BACKGROUND

• 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.

  PMID: 24552647 BACKGROUND

• 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.

  PMID: 20576649 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Study Officials

• Mary B Engler, Ph.D.

  National Institute of Nursing Research (NINR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 5, 2015
• Study Start: February 19, 2015
• Primary Completion: May 9, 2017
• Study Completion: May 9, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-05-09