Haskap and Endurance Running Performance | NCT04837898

Studies
Haskap and Endurance Running Performance

NCT04837898

Sponsor

Northumbria University

Status

Completed

Last Update Posted

Apr 13, 2022Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Exercise Performance

Interventions

Haskapa
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2021Actual

Primary Completion Date

Nov 8, 2021Actual

Completion Date

Dec 8, 2021Actual

First Submitted Date

Apr 6, 2021

First Submission Date that Met QC Criteria

Apr 6, 2021

First Posted Date

Apr 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2022

Last Update Posted Date

Apr 13, 2022Actual

Name	Class
Mibelle Group Biochemistry	INDUSTRY
Haskapa Ltd	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Haskap berry	Active Comparator	A commercially available haskap berry freeze-dried) powder	Dietary Supplement: Haskapa
Placebo	Placebo Comparator	Black cherry KoolAid (Kraft Foods, USA) with added maltodextrin to match carbohydrate and calorie content	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Haskapa	Dietary Supplement	Haskapa Ltd, Oxford, UK	Haskap berry
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
5km time trial	time to complete the trial (seconds)	Change from baseline at 7 days
V̇O2peak test	time to exhaustion (seconds)	Change from baseline at 7 days

Secondary Outcomes

Measure	Description	Time Frame
Blood lactate response during submaximal tests, maximal and time trial	lactate (mmol/L)	Change from baseline at 7 days
rating of perceived exertion during submaximal tests, maximal and time trial

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northumbria University		Newcastle upon Tyne		NE18ST	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided