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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05010057
Other study ID # UEC/2015/112/FHMS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 10, 2016
Est. completion date September 1, 2018

Study information

Verified date August 2021
Source University of Surrey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date September 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
New Zealand blackcurrants (NZBC)
NZBC capsules containing anthocyanin-rich blackcurrant extract
Placebo (PLA)
Placebo capsules containing microcrystalline cellulose

Locations

Country Name City State
United Kingdom Surrey Human Performance Institute Guildford Surrey

Sponsors (1)

Lead Sponsor Collaborator
University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 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 At baseline (pre-exercise) and post-exercise time points (at 0, 24, 48, 72 and 96 hours respectively).
Secondary 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 At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).
Secondary Change in joint range of motion (ROM) from baseline to 96 hours post-exercise Elbow ROM measured using a goniometer At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).
Secondary 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). At baseline (pre-exercise) and post-exercise time points (at 24, 48, 72 and 96 hours respectively).
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