- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04837898
Haskap and Endurance Running Performance
April 5, 2022 updated by: Northumbria University
The Influence of Haskap Berry on Exercise Performance
This study will employ a randomised, double-blind, placebo-controlled, independent groups experimental design.
Submaximal, maximal and 5 km time trial running performance will be assessed before and after supplementation with haskap berry or a placebo.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will consume haskap berry powder or an isocaloric placebo for 7 days.
They will be required to run on a treadmill before and after supplementation to asses the influence on the intervention on aerobic performance parameters.
Other performance parameters such as blood lactate, heart rate, ratings of perceived exertion and respiratory variables will also be monitored throughout the various elements of the exercise trials.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- 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
-
-
-
Newcastle Upon Tyne, United Kingdom, NE18ST
- Northumbria University
-
-
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
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- healthy non-smoking males
- completed a 5 km run (in less than 25 minutes) within the 6 weeks prior to the study
Exclusion Criteria:
- female
- allergies to fruit or dairy, currently taking any nutritional supplements (e.g. vitamins, antioxidant, herbal or sports enhancing supplements) or medication that might affect the study outcome
- history of gastrointestinal, renal or cardiovascular disease
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Haskap berry
A commercially available haskap berry freeze-dried) powder
|
Haskapa Ltd, Oxford, UK
|
|
Placebo Comparator: Placebo
Black cherry KoolAid (Kraft Foods, USA) with added maltodextrin to match carbohydrate and calorie content
|
isocaloric to the haskap powder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
5km time trial
Time Frame: Change from baseline at 7 days
|
time to complete the trial (seconds)
|
Change from baseline at 7 days
|
|
V̇O2peak test
Time Frame: Change from baseline at 7 days
|
time to exhaustion (seconds)
|
Change from baseline at 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood lactate response during submaximal tests, maximal and time trial
Time Frame: Change from baseline at 7 days
|
lactate (mmol/L)
|
Change from baseline at 7 days
|
|
rating of perceived exertion during submaximal tests, maximal and time trial
Time Frame: Change from baseline at 7 days
|
RPE (/20)
|
Change from baseline at 7 days
|
|
heart rate during submaximal tests, maximal and time trial
Time Frame: Change from baseline at 7 days
|
(BPM)
|
Change from baseline at 7 days
|
|
VO2 during submaximal tests, maximal tests
Time Frame: Change from baseline at 7 days
|
(oxygen uptake - relative ml/kg/min and absolute l/min)
|
Change from baseline at 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 12, 2021
Primary Completion (Actual)
November 8, 2021
Study Completion (Actual)
December 8, 2021
Study Registration Dates
First Submitted
April 6, 2021
First Submitted That Met QC Criteria
April 6, 2021
First Posted (Actual)
April 8, 2021
Study Record Updates
Last Update Posted (Actual)
April 13, 2022
Last Update Submitted That Met QC Criteria
April 5, 2022
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 26514
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Data will be held by on a secure data based by the PI and made available to others but in line with contractual agreements with the funder and legal requirements of General Data Protection Regulations (GDPR) in the UK.
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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