- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05010057
The Effect of New Zealand Blackcurrant (NZBC) Supplementation on Recovery Following Strenuous Exercise (CurraNZ_MD)
August 17, 2021 updated by: University of Surrey
The Effect of New Zealand Blackcurrant (NZBC) Supplementation on Indices of Muscle Damage Following Strenuous Exercise
The study aims to examine the effect of a New Zealand blackcurrant (NZBC) supplement on markers of muscle damage and recovery following strenuous resistance exercise.
The investigation will compare responses between an experimental (NZBC capsule, 300 mg/day) and placebo (PLA capsule, 300 mg sugar) group.
Participants will attend a screening session where they will consent to the study, complete a pre-activity medical questionnaire and have their height, weight and resting blood pressure measured.
If the participants meet the inclusion criteria they will perform a familarisation session on the muscle strength assessment.
Participants will be randomized to NZBC or placebo groups, and consume one capsule in the morning (between 6-10 am) for 12 days.
This is a double-blinded study, which means that the participant and the study team will not know which group the participants are assigned to until the study is over.
On day 8 participants will perform a strenuous bout of upper body resistance exercise on the isokinetic dynamometer (exercise device).
Muscle strength and soreness, arm circumference, and elbow range of motion will be measured, and a fasted blood sample will be collected, before and 24, 48, 72 & 96 hours after the muscle fatigue protocol (on days 9, 10, 11 & 12).
A marker of muscle damage (creatine kinase [CK] concentration) will be measured in the blood samples.
Participants will also be asked to complete a 6-day dietary record, beginning on day 7 and ending on the final day of testing (day 12).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
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
-
-
Surrey
-
Guildford, Surrey, United Kingdom, GU2 7AD
- Surrey Human Performance Institute
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and Females
- 18 - 45 years old
- BMI: 19 - 29.9 kg/m2
- Healthy: no active disease process that could interfere with endpoints measured as determined by medical history
Exclusion Criteria:
- Smoking and tobacco use
- Takes medication [excluding contraception]
- BMI ≥ 30 kg/m2
- Hypertensive (diastolic > 90 and/or systolic blood pressure > 140 mmHg)
- History of musculoskeletal upper limb injuries
- Performs regular resistance exercise (> 2 sessions per week)
- Uses dietary supplements that could influence muscle recovery or function (e.g. protein supplements, antioxidants etc)
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: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: New Zealand blackcurrants (NZBC)
1 NZBC capsule (containing 300 mg active cassis containing 105 mg of anthocyanins, i.e. 35-50 % delphinidin-3-rutinoside, 5-20 % delphinidin-3-glucoside, 30-45 % cyanidin-3-rutinoside, 3-10 % cyanidin-3-glucoside), consumed in the morning, for 12 days.
|
NZBC capsules containing anthocyanin-rich blackcurrant extract
Other Names:
|
PLACEBO_COMPARATOR: Placebo (PLA)
1 placebo capsule (containing 300 mg microcrystalline cellulose M102), consumed in the morning, for 12 days.
|
Placebo capsules containing microcrystalline cellulose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in creatine kinase (CK) concentration at 72 hours post-exercise
Time Frame: At baseline (pre-exercise) and 72 hours post-exercise.
|
Serum biomarker for muscle damage
|
At baseline (pre-exercise) and 72 hours post-exercise.
|
Change from baseline in creatine kinase (CK) concentration at 96 hours post-exercise
Time Frame: At baseline (pre-exercise) and 96 hours post-exercise..
|
Serum biomarker for muscle damage
|
At baseline (pre-exercise) and 96 hours post-exercise..
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in maximum voluntary contraction (MVC) from baseline to 96 hours post-exercise
Time Frame: At baseline (pre-exercise) and post-exercise time points (at 0, 24, 48, 72 and 96 hours respectively).
|
Muscle function measure; maximal voluntary isometric contraction (torque, Nm) performed on isokinetic dynamometer
|
At baseline (pre-exercise) and post-exercise time points (at 0, 24, 48, 72 and 96 hours respectively).
|
Change in rating of Delayed Onset of Muscle Soreness (DOMS) from baseline to 96 hours post-exercise
Time Frame: At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).
|
Self-reported perception of muscle soreness using a visual analogue scale (VAS), from 'no soreness' [0 mm] on the left anchor point to 'extremely sore' [100 mm] on the right
|
At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).
|
Change in joint range of motion (ROM) from baseline to 96 hours post-exercise
Time Frame: At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).
|
Elbow ROM measured using a goniometer
|
At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).
|
Change in mid arm circumference (MAC) from baseline to 96 hours post-exercise
Time Frame: At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).
|
Mid-upper arm circumference measured at the midpoint of the distance from the acromion process (acromiale) to the olecranon process (radiale).
|
At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julie EA Hunt, PhD, University of Surrey
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)
June 10, 2016
Primary Completion (ACTUAL)
September 1, 2018
Study Completion (ACTUAL)
September 1, 2018
Study Registration Dates
First Submitted
August 6, 2021
First Submitted That Met QC Criteria
August 17, 2021
First Posted (ACTUAL)
August 18, 2021
Study Record Updates
Last Update Posted (ACTUAL)
August 18, 2021
Last Update Submitted That Met QC Criteria
August 17, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UEC/2015/112/FHMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Will provide basic data spreadsheet upon request.
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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