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AbnormalitiesNCT02019680

Study of the Effects of Blackcurrant Extract and Omega-3 Fats on the Health of the Heart and Blood Vessels

An observational study of Abnormalities and Hyperlipidemia, 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Withdrawn

Withdrawn.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 in the United States. Eating fruits and vegetables with chemicals called flavonoids may protect against heart disease and improve blood flow to the heart. They are found in blackcurrant berries. Read more about this study

Who is it for?
Ages 55 to 75 yearsHealthy volunteers can take part
How many people
0 participants
Where
No sites listed yet
Study dates
10 Dec 2013to 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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men and women between the ages of 55-75 years
  • In general good health as determined by screening evaluation
  • Normal or pre-hypertensive blood pressure (e.g. Systolic less than or equal to 139 mm Hg and Diastolic less than or equal to 89 mm Hg
  • Normal or mild hyperlipidemia (e. g. Total Cholesterol less than or equal to 239, LDL less than or equal to 159, Triglycerides less than or equal to 199, HDL less than or equal to 40 mg/dL)
  • BMI between 18.5 to 25 kg/m^2
  • Willingness and ability to give consent
  • Willingness to make time commitment for the study

Who cannot join

  • Progressive or unstable disease of any body system including cardiovascular, pulmonary, gastrointestinal, central nervous system, psychiatric, endocrine, hematologic, renal or immunologic disorders
  • Known acute or chronic inflammatory disease ( e.g. rheumatoid arthritis, systemic lupus erythematosus, hepatitis)
  • Elevated C-reactive protein (CRP) level > 3.0 mg/L
  • Elevated fasting blood glucose level > 120 mg/dL
  • Elevated lipid profile : Total cholesterol > 239 mg/dL, Triglycerides > 200 mg/dL, LDL >160mg/dL
  • Abnormal complete blood count (CBC): White Blood Cell Count < 4 or > 10 K/uL, Red Blood Cell Count < 4 or > 7 M/uL, Hemoglobin < 13 or > 18 g/dL, Hematocrit < 39 or > 52%
Show all 16Show fewer
  • Recent or ongoing alcohol or drug abuse (Subjects with moderate alcohol consumption described as 12oz. of beer, 5oz. glasses of wine, or 1.5 glasses of hard liquor/day or greater alcohol consumption will be excluded.)
  • Known sensitivity or allergy to fish oil, or shell fish
  • Smoking any tobacco products (cigarettes, pipe, etc.)
  • Subjects currently taking fish oil supplements (participation is possible after 2 month washout period)
  • Subjects taking blood thinners (i.e., Coumadin, warfarin etc.)
  • Subjects with bleeding disorders (i.e., hemophilia)
  • Subjects taking cholesterol-lowering, anti-hypertensive, thyroid or hormonal medications
  • Subjects taking aspirin, non-steroidal anti-inflammatory (NSAIDS) medications or fish oil on a regular basis unless they were discontinued 14 days prior to their first visit.
  • Subjects starting cholesterol-lowering, anti-hypertensive, thyroid or hormonal medications or fish oil during the study
  • Subjects taking supplements unless they were discontinued 14 days prior to their first visit.

About this study

Official title: Effects of Dietary Blackcurrant Extract and PCSO-524 (PernaCanaliculus Supercritical Oil) on Endothelial Function and Biomarkers of Vascular Health

Background:

  • Heart disease is the leading cause of death in the United States. Eating fruits and vegetables with chemicals called flavonoids may protect against heart disease and improve blood flow to the heart. They are found in blackcurrant berries. Oils found in fish and mussels called omega-3 fats have also been shown to protect the heart. Researchers want to know if blackcurrant extract and omega-3 fats can improve blood flow, which may increase blood to the heart. They also want to learn about the health of blood vessels and how the heart works.
Read more

Objective:

  • To learn if blackcurrant extract and omega-3 fats will improve blood flow and make the heart beat stronger.

Eligibility:

  • Healthy adults 55 to 75 years old.

Design:

  • Participants will be screened with medical history, physical exam, and blood tests.
  • Visit 1 will take 6 7 hours.
  • Participants will have physical exam and blood and urine tests.
  • A small device like a microphone will be placed on their arm to take pictures of blood vessels. A blood pressure cuff will be tightened on their arm and more pictures will be taken.
  • Blood pressure cuffs will be placed on their arms and legs. They will be tightened at the same time and blood pressure will be measured.
  • Participants will answer questions about their eating and exercise.
  • Every 8 weeks, participants switch from taking blackcurrant and/or omega-3 tablets to a placebo to no tablets. <TAB>
  • Every 8 weeks, they will have another shorter clinic visit that will repeat most of visit 1.
Read the detailed description

Numerous studies have shown the beneficial effects of fruits, vegetables and omega-3 fatty acids in reducing the risk of cardiovascular disease. The cardioprotective properties may be attributed to the bioactive compounds found in fruits and vegetables called flavonoids. High concentrations of flavonoids with antioxidant activity are found in blackcurrant extract. Flavonoids like omega-3 fatty acids may improve vascular function by increasing the bioavailability of nitric oxide, a potent vasodilator. PCSO-524 (Pernacanaliculus supercritical oil) is of particular interest as a rich source of omega-3 fatty acids derived from the green-lipped mussel. The objectives of this study are to determine the effects of blackcurrant extract, PCSO-524 or the combination of blackcurrant extract \& PCSO-524 on endothelial function (flow-mediated brachial artery dilation) and arterial stiffness (cardioankle vascular index) as indicators of cardiovascular risk and atherosclerosis. These indices also provide an assessment of structure and function of the artery. The effects of the supplements on biomarkers of vascular health (endothelial dysfunction, inflammation, injury, oxidative stress, nitric oxide status), lipids and fatty acid profile, and flavonoid profiles will also be determined. In a randomized, double-blind, placebo-controlled trial, 122 healthy older adults (ages 55-75) will be given either blackcurrant extract (1000 mg), PCSO-524 (400 mg), or blackcurrant extract (1000 mg) \& PCSO-524 (400 mg) daily for 8 weeks while consuming their usual diet. The study will include 4 visits at 8 week intervals consisting of treatment, washout and placebo phases.

Keywords
Endothelial Function, Biomarkers, Atherosclerosis, Blood Flow, Blood Pressure
Medical subject headings
Congenital Abnormalities, Hyperlipidemias, Cardiovascular Diseases, Arteriosclerosis, Atherosclerosis

What is being measured

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

  1. Endothelial function (flow-mediated brachial artery dilation) and arterial stiffness (cardio-ankle vascular index)

    Measured: 8 weeks x 4

Secondary outcomes (1)

  1. Biomarkers of vascular health (endothelial dysfunction, inflammation, injury, oxidative stress, nitric oxide status), lipids and fatty acid profile, and flavonoid profiles

    Measured: 8 weeks x 4

Timeline

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

  1. First posted24 Dec 2013 (estimated)
  2. Study start10 Dec 2013
  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
NCT02019680
Sponsor's protocol ID
140034
Other IDs
14-NR-0034
Status last verified
9 May 2017
First submitted
20 Dec 2013
Last updated
2 Jul 2017
Results posted
No

Publications

  • Joshipura KJ, Hu FB, Manson JE, Stampfer MJ, Rimm EB, Speizer FE, Colditz G, Ascherio A, Rosner B, Spiegelman D, Willett WC. The effect of fruit and vegetable intake on risk for coronary heart disease. Ann Intern Med. 2001 Jun 19;134(12):1106-14. doi: 10.7326/0003-4819-134-12-200106190-00010.

    PubMed 11412050

  • Ness AR, Powles JW. Fruit and vegetables, and cardiovascular disease: a review. Int J Epidemiol. 1997 Feb;26(1):1-13. doi: 10.1093/ije/26.1.1.

    PubMed 9126498

  • Hertog MG, Feskens EJ, Hollman PC, Katan MB, Kromhout D. Dietary antioxidant flavonoids and risk of coronary heart disease: the Zutphen Elderly Study. Lancet. 1993 Oct 23;342(8878):1007-11. doi: 10.1016/0140-6736(93)92876-u.

    PubMed 8105262

Questions about this trial

What is this clinical trial studying?

An observational study of Abnormalities and Hyperlipidemia, 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 7 inclusion and 16 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 2 Jul 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 (flow-mediated brachial artery dilation) and arterial stiffness (cardio-ankle vascular index) (time frame: 8 weeks x 4). 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 NCT02019680, 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 2 Jul 2017.

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