no ConditionsNCT05067062

Intake Duration Effects of Blackcurrant on Cardiovascular and Metabolic Responses

A study testing New Zealand blackcurrant extract in people with no Conditions, run by University of Chichester at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: no Conditions
What is being tested?: New Zealand blackcurrant extract
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Sep 2017to 1 Sep 2018
Phase: Interventional
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 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

Sedentary
Known high blood pressure
Smoking
On medication

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Mark Willems
Chichester, West Sussex, PO19 6PE

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions: no Conditions
Being tested: New Zealand blackcurrant extract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

New Zealand blackcurrant extractDietary supplement
Capsules taken daily or intermittent

Study groups in NCT05067062
Study group	Role	What they receive
new zealand blackcurrant extract	Active comparator	Capsules will be take daily or every other day. Receives: Dietary Supplement: New Zealand blackcurrant extract
control	Placebo comparator	no capsules will be provided. Receives: Dietary Supplement: New Zealand blackcurrant extract

What is being measured

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

Changes in heart rate from baseline with acute intake, one week and two weeks intake of New Zealand blackcurrant extract
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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
Measured: baseline, acute, one week and two weeks

Secondary outcomes (5)

Changes in oxygen consumption from baseline with acute intake, one week and two weeks intake.
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
Measured: baseline, acute, one week and two weeks
Changes in carbon dioxide production from baseline with acute intake, one week and two weeks intake.
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.
Measured: baseline, acute, one week and two weeks
Changes in respiratory exchange ratio from baseline with acute intake, one week and two weeks intake.
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.
Measured: baseline, acute, one week and two weeks
Changes in carbohydrate oxidation from baseline with acute intake, one week and two weeks intake.
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.
Measured: baseline, acute, one week and two weeks
Changes in fat oxidation from baseline with acute intake, one week and two weeks intake.
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.
Measured: baseline, acute, one week and two weeks

Timeline

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

1 Sep 20171 Sep 2018

First posted4 Oct 2021
Study start1 Sep 2017
Primary completion1 Sep 2018
Study completion1 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for no ConditionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05067062
Sponsor's protocol ID: MW1718NZBCduration
Status last verified: Oct 2021
First submitted: 10 Sep 2021
Last updated: 4 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: But will be provide on request.

Publications

Sahin PhD MA, Bilgic PhD P, Montanari MSc S, Willems PhD MET. Intake Duration of Anthocyanin-Rich New Zealand Blackcurrant Extract Affects Metabolic Responses during Moderate Intensity Walking Exercise in Adult Males. J Diet Suppl. 2021;18(4):406-417. doi: 10.1080/19390211.2020.1783421. Epub 2020 Jun 24.
PubMed 32578472
Sahin PhD MA, Bilgic PhD P, Montanari MSc S, Willems PhD MET. Daily and Not Every-Other-Day Intake of Anthocyanin-Rich New Zealand Blackcurrant Extract Alters Substrate Oxidation during Moderate-Intensity Walking in Adult Males. J Diet Suppl. 2022;19(1):49-61. doi: 10.1080/19390211.2020.1841356. Epub 2020 Oct 29.
PubMed 33118421

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05067062
Acronym / sponsor ID: MW1718NZBCduration
Conditions: no Conditions
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of ChichesterUniversity, hospital or other
Study start: 1 Sep 2017 (actual)
Primary completion: 1 Sep 2018 (actual)
Study completion: 1 Sep 2018 (actual)
First posted: 4 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
new zealand blackcurrant extract	Active comparator	Dietary Supplement: New Zealand blackcurrant extractCapsules will be take daily or every other day.
control	Placebo comparator	Dietary Supplement: New Zealand blackcurrant extractno capsules will be provided.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

Sedentary
Known high blood pressure
Smoking
On medication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
New Zealand blackcurrant extractCapsules taken daily or intermittent	Dietary supplement	control, new zealand blackcurrant extract

Primary outcome

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.
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.
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.
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.
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

5 secondary outcomes

Changes in oxygen consumption from baseline with acute intake, one week and two weeks intake.
Time frame: 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
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
Changes in carbohydrate oxidation from baseline with acute intake, one week and two weeks intake.
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
Background: PubMed 32578472Sahin PhD MA, Bilgic PhD P, Montanari MSc S, Willems PhD MET. Intake Duration of Anthocyanin-Rich New Zealand Blackcurrant Extract Affects Metabolic Responses during Moderate Intensity Walking Exercise in Adult Males. J Diet Suppl. 2021;18(4):406-417. doi: 10.1080/19390211.2020.1783421. Epub 2020 Jun 24.
Results publication: PubMed 33118421Sahin PhD MA, Bilgic PhD P, Montanari MSc S, Willems PhD MET. Daily and Not Every-Other-Day Intake of Anthocyanin-Rich New Zealand Blackcurrant Extract Alters Substrate Oxidation during Moderate-Intensity Walking in Adult Males. J Diet Suppl. 2022;19(1):49-61. doi: 10.1080/19390211.2020.1841356. Epub 2020 Oct 29.
Individual participant dataSharing planned: No. But will be provide on request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark E Willems, PhD principal investigator

University of Chichester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing New Zealand blackcurrant extract in people with no Conditions, run by University of Chichester at 1 site in United Kingdom.

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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 study lists 5 primary outcomes in all. 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 NCT05067062, which also lists 2 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 4 Oct 2021.