- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06391957
Spirulina Supplementation In Recovery From Damaging Exercise (SPIRAL)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Benjamin Wall, Prof
- Phone Number: +441392724774
- Email: b.t.wall@exeter.ac.uk
Study Locations
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-
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Exeter, United Kingdom
- Recruiting
- University of Exeter
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Contact:
- Ellen Williamson
- Phone Number: 07791054736
- Email: ew655@exeter.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Spirulina supplement
3g of spirulina supplement three times daily for 5 days.
|
Participants consume a 3g spirulina supplement 3 times daily for 5 consecutive days.
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.
|
Placebo Comparator: Placebo supplement
macronutrient matched placebo supplement three times daily for 5 days.
|
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.
Participants consume a macronutrient matched placebo supplement 3 times daily for 5 consecutive days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure changes in the concentration of blood plasma inflammatory markers via immunoassay.
Time Frame: Measurements take place across a 6 day experimental period.
|
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 γ (IFN-γ), interleukin (IL) -1β, -4, -6, -10, tumour necrosis factor α (TNF-α) via immunoassay (pg/mL).
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Measurements take place across a 6 day experimental period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure changes in muscle function of the quadriceps using knee extensor peak isometric torque and total isokinetic work on a Biodex System 3 isokinetic dynamometer.
Time Frame: Measurements take place across a 6 day experimental period.
|
Muscle function of the quadriceps 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 function. Muscle function testing will be performed on a Biodex System 3 isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, US). Muscle function measurements will include:
|
Measurements take place across a 6 day experimental period.
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Measure changes in perceived lower body muscle soreness via visual analogue scale questionnaire.
Time Frame: Measurements take place across a 6 day experimental period.
|
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.
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Measurements take place across a 6 day experimental period.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 4530276
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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