NCT05067062

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
Last Updated

October 4, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

September 10, 2021

Last Update Submit

October 1, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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

    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.

    baseline, acute, one week and two weeks

  • Changes in carbon dioxide production from baseline with acute intake, one week and two weeks intake.

    baseline, acute, one week and two weeks

  • Changes in respiratory exchange ratio from baseline with acute intake, one week and two weeks intake.

    baseline, acute, one week and two weeks

  • Changes in carbohydrate oxidation from baseline with acute intake, one week and two weeks intake.

    baseline, acute, one week and two weeks

  • Changes in fat oxidation from baseline with acute intake, one week and two weeks intake.

    baseline, acute, one week and two weeks

Study Arms (2)

new zealand blackcurrant extract

ACTIVE COMPARATOR

Capsules will be take daily or every other day.

Dietary Supplement: New Zealand blackcurrant extract

control

PLACEBO COMPARATOR

no capsules will be provided.

Dietary Supplement: New Zealand blackcurrant extract

Interventions

Capsules taken daily or intermittent

controlnew zealand blackcurrant extract

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mark Willems

Chichester, West Sussex, PO19 6PE, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 32578472BACKGROUND
  • 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.

Study Officials

  • Mark E Willems, PhD

    University of Chichester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Exercise Physiology

Study Record Dates

First Submitted

September 10, 2021

First Posted

October 4, 2021

Study Start

September 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

October 4, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

But will be provide on request.

Locations