Damage MuscleSPIRALNCT06391957
Spirulina Supplementation In Recovery From Damaging Exercise
A study testing Spirulina supplement and Eccentric exercise in people with Damage Muscle, run by University of Exeter at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Damage Muscle
- What is being tested?
- Spirulina supplement and Eccentric exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Exeter
Exeter
Ellen Williamson, 07791054736, ew655@exeter.ac.uk
About this study
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.
- Conditions
- Damage Muscle
- Being tested
- Spirulina supplement, Eccentric exercise, Placebo supplement
- Keywords
- spirulina, exercise recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirulina supplementDietary supplement
Participants consume a 3g spirulina supplement 3 times daily for 5 consecutive days.
Eccentric exerciseProcedure or surgery
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 supplementDietary supplement
Participants consume a macronutrient matched placebo supplement 3 times daily for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Spirulina supplement | Experimental | 3g of spirulina supplement three times daily for 5 days. Receives: Dietary Supplement: Spirulina supplement; Procedure: Eccentric exercise |
| Placebo supplement | Placebo comparator | macronutrient matched placebo supplement three times daily for 5 days. Receives: Procedure: Eccentric exercise; Dietary Supplement: Placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 γ (IFN-γ), interleukin (IL) -1β, -4, -6, -10, tumour necrosis factor α (TNF-α) via immunoassay (pg/mL).
Measured: Measurements take place across a 6 day experimental period.
Secondary outcomes (3)
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).
Measured: 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.
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).
Measured: Measurements take place across a 6 day experimental period.
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.
Measured: Measurements take place across a 6 day experimental period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start4 Jan 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Damage MuscleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391957
- Sponsor's protocol ID
- 4530276
- Acronym
- SPIRAL
- Status last verified
- Jun 2024
- First submitted
- 22 Apr 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spirulina Supplementation In Recovery From Damaging Exercise
- ClinicalTrials.gov ID
- NCT06391957
- Acronym / sponsor ID
- SPIRAL / 4530276
- Conditions
- Damage Muscle
- Keywords
- spirulina, exercise recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spirulina supplement | Experimental | Dietary Supplement: Spirulina supplement, Procedure: Eccentric exercise3g of spirulina supplement three times daily for 5 days. |
| Placebo supplement | Placebo comparator | Procedure: Eccentric exercise, Dietary Supplement: Placebo supplementmacronutrient matched placebo supplement three times daily for 5 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirulina supplementParticipants consume a 3g spirulina supplement 3 times daily for 5 consecutive days. | Dietary supplement | Spirulina supplement |
| Eccentric exerciseOn 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. | Procedure or surgery | Placebo supplement, Spirulina supplement |
| Placebo supplementParticipants consume a macronutrient matched placebo supplement 3 times daily for 5 consecutive days. | Dietary supplement | Placebo supplement |
Primary outcome
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).
3 secondary outcomes
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.
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.
Measure changes in perceived lower body muscle soreness via visual analogue scale questionnaire.
Time frame: Measurements take place across a 6 day experimental period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirulina supplement and Eccentric exercise in people with Damage Muscle, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Wall, Prof (+441392724774, b.t.wall@exeter.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure changes in the concentration of blood plasma inflammatory markers via immunoassay. (time frame: Measurements take place across a 6 day experimental period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.