Intake Duration Effects of Blackcurrant on Cardiovascular and Metabolic Responses

October 1, 2021 updated by: Mark Eilisabeth Willems, University of Chichester

Effects of Intake Duration of New Zealand Blackcurrant Extract on Physiological, Cardiovascular and Metabolic Responses at Rest and During Moderate-intensity Exercise in Healthy Males

Study will examine the metabolic, physiological and cardiovascular changes by intake of New Zealand blackcurrant extract at rest and during moderate-intensity treadmill walking in healthy males.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators will examine effects of acute intake, intermittent intake and chronic intake of New Zealand blackcurrant extract using indirect calorimetry and hemodynamic measurements.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Sussex
      • Chichester, West Sussex, United Kingdom, PO19 6PE
        • Mark Willems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy
  • Non-smokers
  • Not taking any supplements
  • No known allergy to berries or berry products

Exclusion Criteria

  • Sedentary
  • Known high blood pressure
  • Smoking
  • On medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: new zealand blackcurrant extract
Capsules will be take daily or every other day.
Dietary supplement: New Zealand blackcurrant extract
Capsules taken daily or intermittent
Placebo Comparator: control
no capsules will be provided.
Dietary supplement: New Zealand blackcurrant extract
Capsules taken daily or intermittent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in heart rate from baseline with acute intake, one week and two weeks intake of New Zealand blackcurrant extract
Time Frame: baseline, acute, one week and two weeks

The investigators will use a beat-to-beat blood pressure monitoring system (Portapres® Model 2, Finapres Medical Systems BV, Amsterdam, The Netherlands). The Portapres® is a beat-to-beat finger pressure analyser that allows the non-invasive continuous measurement of hemodynamic parameters. The finger cuff will be positioned around the same finger of the left hand for each testing. All measurements will be taken in rest and during moderate-intensity exercise.

Heart rate will be measured in beats/min.
baseline, acute, one week and two weeks
Changes in stroke volume from baseline with acute intake, one week and two weeks intake of New Zealand blackcurrant extract
Time Frame: baseline, acute, one week and two weeks

The investigators will use a beat-to-beat blood pressure monitoring system (Portapres® Model 2, Finapres Medical Systems BV, Amsterdam, The Netherlands). The Portapres® is a beat-to-beat finger pressure analyser that allows the non-invasive continuous measurement of hemodynamic parameters. The finger cuff will be positioned around the same finger of the left hand for each testing. All measurements will be taken in rest and during moderate-intensity exercise.

Stroke volume will be measured in mL.
baseline, acute, one week and two weeks
Changes in cardiac output from baseline with acute intake, one week and two weeks intake of New Zealand blackcurrant extract
Time Frame: baseline, acute, one week and two weeks

The investigators will use a beat-to-beat blood pressure monitoring system (Portapres® Model 2, Finapres Medical Systems BV, Amsterdam, The Netherlands). The Portapres® is a beat-to-beat finger pressure analyser that allows the non-invasive continuous measurement of hemodynamic parameters. The finger cuff will be positioned around the same finger of the left hand for each testing. All measurements will be taken in rest and during moderate-intensity exercise.

Cardiac output will be measured in L/min.
baseline, acute, one week and two weeks
Changes in blood pressure from baseline with acute intake, one week and two weeks intake of New Zealand blackcurrant extract
Time Frame: baseline, acute, one week and two weeks

The investigators will use a beat-to-beat blood pressure monitoring system (Portapres® Model 2, Finapres Medical Systems BV, Amsterdam, The Netherlands). The Portapres® is a beat-to-beat finger pressure analyser that allows the non-invasive continuous measurement of hemodynamic parameters. The finger cuff will be positioned around the same finger of the left hand for each testing. All measurements will be taken in rest and during moderate-intensity exercise.

Systolic, diastolic and mean arterial blood pressure will be measured in mmHg.
baseline, acute, one week and two weeks
Changes in total peripheral resistance from baseline with acute intake, one week and two weeks intake of New Zealand blackcurrant extract
Time Frame: baseline, acute, one week and two weeks

The investigators will use a beat-to-beat blood pressure monitoring system (Portapres® Model 2, Finapres Medical Systems BV, Amsterdam, The Netherlands). The Portapres® is a beat-to-beat finger pressure analyser that allows the non-invasive continuous measurement of hemodynamic parameters. The finger cuff will be positioned around the same finger of the left hand for each testing. All measurements will be taken in rest and during moderate-intensity exercise.

Total peripheral resistance will be measured in (mmHg·min)/L
baseline, acute, one week and two weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in oxygen consumption from baseline with acute intake, one week and two weeks intake.
Time Frame: baseline, acute, one week and two weeks

The investigators will use Douglas bags to collect expired air. Indirect calorimetry techniques will be used to measured oxygen consumption and carbon dioxide production and allow quantification of carbohydrate and fat oxidation in rest and during moderate-intensity treadmill walking.

Oxygen consumption will be measured in L/min
baseline, acute, one week and two weeks
Changes in carbon dioxide production from baseline with acute intake, one week and two weeks intake.
Time Frame: baseline, acute, one week and two weeks

The investigators will use Douglas bags to collect expired air. Indirect calorimetry techniques will be used to measured oxygen consumption and carbon dioxide production and allow quantification of carbohydrate and fat oxidation in rest and during moderate-intensity treadmill walking.

Carbon dioxide production will be measured in L/min.
baseline, acute, one week and two weeks
Changes in respiratory exchange ratio from baseline with acute intake, one week and two weeks intake.
Time Frame: baseline, acute, one week and two weeks

The investigators will use Douglas bags to collect expired air. Indirect calorimetry techniques will be used to measured oxygen consumption and carbon dioxide production and allow quantification of carbohydrate and fat oxidation in rest and during moderate-intensity treadmill walking.

Respiratory exchange ratio is unitless and calculated from the ratio of carbon dioxide production and oxygen consumption.
baseline, acute, one week and two weeks
Changes in carbohydrate oxidation from baseline with acute intake, one week and two weeks intake.
Time Frame: baseline, acute, one week and two weeks

The investigators will use Douglas bags to collect expired air. Indirect calorimetry techniques will be used to measured oxygen consumption and carbon dioxide production and allow quantification of carbohydrate and fat oxidation in rest and during moderate-intensity treadmill walking.

Carbohydrate oxidation is calculated using carbon dioxide production and oxygen consumption and expressed in g/min.
baseline, acute, one week and two weeks
Changes in fat oxidation from baseline with acute intake, one week and two weeks intake.
Time Frame: baseline, acute, one week and two weeks

The investigators will use Douglas bags to collect expired air. Indirect calorimetry techniques will be used to measured oxygen consumption and carbon dioxide production and allow quantification of carbohydrate and fat oxidation in rest and during moderate-intensity treadmill walking.

Fat oxidation is calculated using carbon dioxide production and oxygen consumption and expressed in g/min.
baseline, acute, one week and two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chichester

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark E Willems, PhD, University of Chichester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MW1718NZBCduration

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

But will be provide on request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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