NCT04837898

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

April 12, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2021

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

April 6, 2021

Last Update Submit

April 5, 2022

Conditions

Keywords

berryrunningtime trial

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • Blood lactate response during submaximal tests, maximal and time trial

    Change from baseline at 7 days

  • rating of perceived exertion during submaximal tests, maximal and time trial

    Change from baseline at 7 days

  • heart rate during submaximal tests, maximal and time trial

    Change from baseline at 7 days

  • VO2 during submaximal tests, maximal tests

    Change from baseline at 7 days

Study Arms (2)

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

HaskapaDIETARY_SUPPLEMENT

Haskapa Ltd, Oxford, UK

Haskap berry
PlaceboDIETARY_SUPPLEMENT

isocaloric to the haskap powder

Placebo

Eligibility Criteria

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

You may qualify if:

  • healthy non-smoking males
  • completed a 5 km run (in less than 25 minutes) within the 6 weeks prior to the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, NE18ST, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Supplement will be pre-weighed by an individual (independent of the study) and provided to participants in sealed packets
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 8, 2021

Study Start

April 12, 2021

Primary Completion

November 8, 2021

Study Completion

December 8, 2021

Last Updated

April 13, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

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.

Locations