Muscle DamageCurraNZ_MDNCT05010057
The Effect of New Zealand Blackcurrant (NZBC) Supplementation on Recovery Following Strenuous Exercise
A study testing New Zealand blackcurrants (NZBC) in people with Muscle Damage, run by University of Surrey at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- New Zealand blackcurrants (NZBC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jun 2016to 1 Sep 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Surrey Human Performance Institute
Guildford, Surrey, GU2 7AD
About this study
Official title: 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).
- Conditions
- Muscle Damage
- Being tested
- New Zealand blackcurrants (NZBC), Placebo (PLA)
- Keywords
- Exercise-induced muscle damage, Recovery, Supplementation, Oxidative stress, Anthocyanin, New Zealand blackcurrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Zealand blackcurrants (NZBC)Dietary supplement
Also called NZBC extract supplement (Health Currancy Ltd [UK] / CurraNZ Ltd [NZ])
NZBC capsules containing anthocyanin-rich blackcurrant extract
Placebo (PLA)Dietary supplement
Also called Placebo capsules
Placebo capsules containing microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| New Zealand blackcurrants (NZBC) | Experimental | 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. Receives: Dietary Supplement: New Zealand blackcurrants (NZBC) |
| Placebo (PLA) | Placebo comparator | 1 placebo capsule (containing 300 mg microcrystalline cellulose M102), consumed in the morning, for 12 days. Receives: Dietary Supplement: Placebo (PLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in creatine kinase (CK) concentration at 72 hours post-exercise
Serum biomarker for muscle damage
Measured: At baseline (pre-exercise) and 72 hours post-exercise.
Change from baseline in creatine kinase (CK) concentration at 96 hours post-exercise
Serum biomarker for muscle damage
Measured: At baseline (pre-exercise) and 96 hours post-exercise..
Secondary outcomes (4)
Change in maximum voluntary contraction (MVC) from baseline to 96 hours post-exercise
Muscle function measure; maximal voluntary isometric contraction (torque, Nm) performed on isokinetic dynamometer
Measured: 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
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
Measured: 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
Elbow ROM measured using a goniometer
Measured: 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
Mid-upper arm circumference measured at the midpoint of the distance from the acromion process (acromiale) to the olecranon process (radiale).
Measured: At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start10 Jun 2016
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, parallel design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie EA Hunt, PhD, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010057
- Sponsor's protocol ID
- UEC/2015/112/FHMS
- Acronym
- CurraNZ_MD
- Status last verified
- Aug 2021
- First submitted
- 6 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will provide basic data spreadsheet upon request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of New Zealand Blackcurrant (NZBC) Supplementation on Indices of Muscle Damage Following Strenuous Exercise
- ClinicalTrials.gov ID
- NCT05010057
- Acronym / sponsor ID
- CurraNZ_MD / UEC/2015/112/FHMS
- Conditions
- Muscle Damage
- Keywords
- Exercise-induced muscle damage, Recovery, Supplementation, Oxidative stress, Anthocyanin, New Zealand blackcurrant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- 10 Jun 2016 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 18 Aug 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomised, parallel design.
| Arm | Type | Receives |
|---|---|---|
| New Zealand blackcurrants (NZBC) | Experimental | Dietary Supplement: 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. |
| Placebo (PLA) | Placebo comparator | Dietary Supplement: Placebo (PLA)1 placebo capsule (containing 300 mg microcrystalline cellulose M102), consumed in the morning, for 12 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| New Zealand blackcurrants (NZBC)Also: NZBC extract supplement (Health Currancy Ltd [UK] / CurraNZ Ltd [NZ])NZBC capsules containing anthocyanin-rich blackcurrant extract | Dietary supplement | New Zealand blackcurrants (NZBC) |
| Placebo (PLA)Also: Placebo capsulesPlacebo capsules containing microcrystalline cellulose | Dietary supplement | Placebo (PLA) |
Primary outcome
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
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
4 secondary outcomes
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).
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).
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).
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).
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 18 Aug 2021.
- Individual participant dataSharing planned: No. Will provide basic data spreadsheet upon request.
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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.
Julie EA Hunt, PhD principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Zealand blackcurrants (NZBC) in people with Muscle Damage, run by University of Surrey 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 4 inclusion and 7 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 18 Aug 2021. 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?
Change from baseline in creatine kinase (CK) concentration at 72 hours post-exercise (time frame: At baseline (pre-exercise) and 72 hours post-exercise.). 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 18 Aug 2021.