- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06391957
Spirulina Supplementation In Recovery From Damaging Exercise (SPIRAL)
June 13, 2024 updated by: University of Exeter
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Benjamin Wall, Prof
- Phone Number: +441392724774
- Email: b.t.wall@exeter.ac.uk
Study Locations
-
-
-
Exeter, United Kingdom
- Recruiting
- University of Exeter
-
Contact:
- Ellen Williamson
- Phone Number: 07791054736
- Email: ew655@exeter.ac.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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).
|
Measurements take place across a 6 day experimental period.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Measurements take place across a 6 day experimental period.
|
|
Measure changes in muscle function of the quadriceps using knee extensor peak isometric torque on a Biodex System 3 isokinetic dynamometer.
Time Frame: Measurements take place across a 6 day experimental period.
|
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.
|
|
Measure changes in muscle function of the quadriceps using knee extensor total isokinetic work on a Biodex System 3 isokinetic dynamometer.
Time Frame: Measurements take place across a 6 day experimental period.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2024
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
April 22, 2024
First Submitted That Met QC Criteria
April 29, 2024
First Posted (Actual)
April 30, 2024
Study Record Updates
Last Update Posted (Actual)
June 14, 2024
Last Update Submitted That Met QC Criteria
June 13, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4530276
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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