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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06391957
Other study ID # 4530276
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 4, 2024
Est. completion date September 30, 2024

Study information

Verified date June 2024
Source University of Exeter
Contact Benjamin Wall, Prof
Phone +441392724774
Email b.t.wall@exeter.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Exercise can cause muscle damage, leading to a loss in muscle function, increased muscle soreness and inflammation. Evidence supports the use of nutritional strategies to help recovery. Spirulina is a type of algae. It is eaten as a food supplement as it is full of micronutrients, some which provide anti-inflammatory benefits. This work will assess the impact of taking spirulina supplements on recovery from hard exercise. Investigators will measure changes in muscle function, soreness and markers of inflammation.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Are available and willing to attend St Luke's Campus, Exeter - Age 18 - 40 - BMI 18.5 - 30 kg/m2 - The participant exercises / plays sport for > 2 h/week, but doesn't do structured resistance strength training - Self-reported as healthy (absence of injury or disease) - Have no known food allergy to algae - Are not taking any over the counter or prescribed medication that might interfere with study, e.g. anti-inflammatory medication - Non-smoker Exclusion Criteria: - Are unable to attend St Luke's Campus, Exeter - Are out-with age range 18 - 40 - BMI below 18.5 or above 30 kg/m2 - The participant does not exercise - The participant does regular structured resistance strength training - Known injury or disease that might influence study outcomes - Have a known food allergy to algae - Are taking over the counter or prescribed medication that might interfere with study, e.g. anti-inflammatory medication - Smoker

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Spirulina supplement
Participants consume a 3g spirulina supplement 3 times daily for 5 consecutive days.
Procedure:
Eccentric exercise
On the morning of Day 3 (where Day 1 is when participants start taking supplements), participants perform a single bout of eccentric exercise. The exercise protocol is performed on a single leg and involves 300 (10 sets of 30 repetitions separated by 120 seconds) voluntary maximal, isokinetic, eccentric contractions of the knee extensor. Exercise is performed using a Biodex System 3 isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, USA), and contractions are performed at 60?/s over an 80? range of motion.
Dietary Supplement:
Placebo supplement
Participants consume a macronutrient matched placebo supplement 3 times daily for 5 consecutive days.

Locations

Country Name City State
United Kingdom University of Exeter Exeter

Sponsors (1)

Lead Sponsor Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure changes in the concentration of blood plasma inflammatory markers via immunoassay. Blood plasma inflammatory markers will be measured before (baseline) and after eccentric exercise (at 3, 6, 24, 48 and 72 h post eccentric exercise) in both the spirulina and placebo group. Inflammatory markers that will be assessed include: interferon ? (IFN-?), interleukin (IL) -1ß, -4, -6, -10, tumour necrosis factor a (TNF-a) via immunoassay (pg/mL). Measurements take place across a 6 day experimental period.
Secondary Measure changes in muscle function of the quadriceps using knee extensor peak isometric torque on a Biodex System 3 isokinetic dynamometer. Knee extensor peak isometric torque (three maximal isometric contractions at 75? of knee flexion) will be measured before (baseline) and after eccentric exercise (at 3, 6, 24, 48 and 72 h post eccentric exercise) in both the spirulina and placebo group to report recovery of peak isometric torque (N). Testing will be performed on a Biodex System 3 isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, US). Measurements take place across a 6 day experimental period.
Secondary Measure changes in muscle function of the quadriceps using knee extensor total isokinetic work on a Biodex System 3 isokinetic dynamometer. Knee extensor total isokinetic work (area under the torque-time curve after 30 maximal, concentric, isokinetic knee extensor contractions performed at 75?/s through an 80? range of motion) will be measured before (baseline) and after eccentric exercise (at 3, 6, 24, 48 and 72 h post eccentric exercise) in both the spirulina and placebo group to report recovery of total isokinetic work (N.s). Testing will be performed on a Biodex System 3 isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, US). Measurements take place across a 6 day experimental period.
Secondary Measure changes in perceived lower body muscle soreness via visual analogue scale questionnaire. Perceived lower body muscle soreness will be measured before (baseline) and after eccentric exercise (at 3, 6, 24, 48 and 72 h post eccentric exercise) in both the spirulina and placebo group to report recovery of muscle. Participants will stand from a seated position and rate the corresponding sensation of lower body muscle soreness on a 100-mm visual analogue scale anchored by 'no pain' at 0 mm and 'worst possible pain' at 100 mm. Measurements take place across a 6 day experimental period.
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