NCT05010057

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration 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

Study Start

First participant enrolled

June 10, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

2.2 years

First QC Date

August 6, 2021

Last Update Submit

August 17, 2021

Conditions

Keywords

Exercise-induced muscle damageRecoverySupplementationOxidative stressAnthocyaninNew Zealand blackcurrant

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in creatine kinase (CK) concentration at 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

    Serum biomarker for muscle damage

    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

    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

    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

    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

    At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).

Study Arms (2)

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.

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.

Dietary Supplement: Placebo (PLA)

Interventions

NZBC capsules containing anthocyanin-rich blackcurrant extract

Also known as: NZBC extract supplement (Health Currancy Ltd [UK] / CurraNZ Ltd [NZ])
New Zealand blackcurrants (NZBC)
Placebo (PLA)DIETARY_SUPPLEMENT

Placebo capsules containing microcrystalline cellulose

Also known as: Placebo capsules
Placebo (PLA)

Eligibility Criteria

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

You may qualify if:

  • Males and Females
  • years old
  • BMI: 19 - 29.9 kg/m2
  • Healthy: no active disease process that could interfere with endpoints measured as determined by medical history

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surrey Human Performance Institute

Guildford, Surrey, GU2 7AD, United Kingdom

Location

Study Officials

  • Julie EA Hunt, PhD

    University of Surrey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Coded, capsules
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised, parallel design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 18, 2021

Study Start

June 10, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 18, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Will provide basic data spreadsheet upon request.

Locations