- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05067062
Intake Duration Effects of Blackcurrant on Cardiovascular and Metabolic Responses
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Sussex
-
Chichester, West Sussex, United Kingdom, PO19 6PE
- Mark Willems
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: new zealand blackcurrant extract
Capsules will be take daily or every other day.
|
Capsules taken daily or intermittent
|
|
Placebo Comparator: control
no capsules will be provided.
|
Capsules taken daily or intermittent
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Investigators
- Principal Investigator: Mark E Willems, PhD, University of Chichester
Publications and helpful links
General 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.
- 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MW1718NZBCduration
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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