Exercise PerformanceNCT04837898
Haskap and Endurance Running Performance
A study testing Haskapa in people with Exercise Performance, run by Northumbria University at 1 site in United Kingdom.
Trial summary
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. 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
- Exercise Performance
- What is being tested?
- Haskapa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Apr 2021to 8 Dec 2021
- 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-smoking males
- completed a 5 km run (in less than 25 minutes) within the 6 weeks prior to the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, NE18ST
About this study
Official title: 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.
Read the 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.
- Conditions
- Exercise Performance
- Being tested
- Haskapa, Placebo
- Keywords
- berry, running, time trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaskapaDietary supplement
Haskapa Ltd, Oxford, UK
PlaceboDietary supplement
isocaloric to the haskap powder
| Study group | Role | What they receive |
|---|---|---|
| Haskap berry | Active comparator | A commercially available haskap berry freeze-dried) powder Receives: Dietary Supplement: Haskapa |
| Placebo | Placebo comparator | Black cherry KoolAid (Kraft Foods, USA) with added maltodextrin to match carbohydrate and calorie content Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
5km time trial
time to complete the trial (seconds)
Measured: Change from baseline at 7 days
V̇O2peak test
time to exhaustion (seconds)
Measured: Change from baseline at 7 days
Secondary outcomes (4)
Blood lactate response during submaximal tests, maximal and time trial
lactate (mmol/L)
Measured: Change from baseline at 7 days
rating of perceived exertion during submaximal tests, maximal and time trial
RPE (/20)
Measured: Change from baseline at 7 days
heart rate during submaximal tests, maximal and time trial
(BPM)
Measured: Change from baseline at 7 days
VO2 during submaximal tests, maximal tests
(oxygen uptake - relative ml/kg/min and absolute l/min)
Measured: Change from baseline at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start12 Apr 2021
- Primary completion8 Nov 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise PerformanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Mibelle Group Biochemistry, Haskapa Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837898
- Sponsor's protocol ID
- 26514
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Haskap Berry on Exercise Performance
- ClinicalTrials.gov ID
- NCT04837898
- Acronym / sponsor ID
- 26514
- Conditions
- Exercise Performance
- Keywords
- berry, running, time trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Mibelle Group Biochemistry, Haskapa Ltd
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 8 Apr 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haskap berry | Active comparator | Dietary Supplement: HaskapaA commercially available haskap berry freeze-dried) powder |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboBlack cherry KoolAid (Kraft Foods, USA) with added maltodextrin to match carbohydrate and calorie content |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy non-smoking males
- completed a 5 km run (in less than 25 minutes) within the 6 weeks prior to the study
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| HaskapaHaskapa Ltd, Oxford, UK | Dietary supplement | Haskap berry |
| Placeboisocaloric to the haskap powder | Dietary supplement | Placebo |
Primary outcome
5km time trial
Time frame: Change from baseline at 7 days
time to complete the trial (seconds)
V̇O2peak test
Time frame: Change from baseline at 7 days
time to exhaustion (seconds)
4 secondary outcomes
Blood lactate response during submaximal tests, maximal and time trial
Time frame: 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
heart rate during submaximal tests, maximal and time trial
Time frame: Change from baseline at 7 days
VO2 during submaximal tests, maximal tests
Time frame: Change from baseline at 7 days
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 13 Apr 2022.
- Individual participant dataSharing planned: No. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haskapa in people with Exercise Performance, run by Northumbria University 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 2 inclusion and 3 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 13 Apr 2022. 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?
5km time trial (time frame: Change from baseline at 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2022.