HealthyPORPHY-ONENCT05760742
Evaluation of the Effects of a Novel Dietary Microalgae Based Ingredient on Muscle Recovery and Endurance Capacity
A study testing MicAlgae in people with Healthy, run by Microphyt at 1 site in United States.
Trial summary
The purpose of this investigation is to examine the effects of consuming a new dietary microalgae based supplement vs. placebo on neuromuscular function, energy utilization, soreness, perceptual wellness, swelling, and markers of muscle damage and inflammation in healthy young men before and after an acute… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MicAlgae
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 18 Aug 2023
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants
- Healthy as assessed by Medical and activity history questionnaire (MHQ)
- Recreationally active according to American College of Sports Medicine guidelines
- Able to provide written and dated informed consent to participate in the study
Who cannot join
- Untrained
- Any response of "yes" on the PAR-Q+
- Physical limitations preventing running, countermovement jump, and strength (peak isometric torque and peak isokinetic torque) assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: Evaluation of the Protective Effects of a Novel Dietary Microalgae Supplement (PeLiv) Following Exercise-induced Muscle Damage and Influence on Endurance Capacity After Prolonged Consumption
The purpose of this investigation is to examine the effects of consuming a new dietary microalgae based supplement vs. placebo on neuromuscular function, energy utilization, soreness, perceptual wellness, swelling, and markers of muscle damage and inflammation in healthy young men before and after an acute exercise-induced muscle damage protocol (downhill running), and influence on endurance capacity after prolonged consumption.
- Conditions
- Healthy
- Being tested
- MicAlgae, Placebo
- Keywords
- recovery, muscle endurance, exercise capacity, microalgae, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicAlgaeDietary supplement
2 months of supplementation with an innovative microalgae based ingredient
PlaceboDietary supplement
2 months of supplementation with a placebo (Maltodextrin)
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | 2 capsules of Maltodextrin per day Receives: Dietary Supplement: Placebo |
| MicAlgae100 | Experimental | 2 capsules per day containing 100mg of microalgae based ingredient Receives: Dietary Supplement: MicAlgae |
| MicAlgae250 | Experimental | 2 capsules per day containing 250mg of microalgae based ingredient Receives: Dietary Supplement: MicAlgae |
| MicAlgae500 | Experimental | 2 capsules per day containing 500mg of microalgae based ingredient Receives: Dietary Supplement: MicAlgae |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular function
isokinetic peak torque in Newton per meter (N/m)
Measured: From 0 to week 4
Secondary outcomes (17)
Energy utilization (Oxygen consumption - VO2)
Running economy during a 5-minute run at 80% of the speed at VO2max with gaz exchange analyzis
Measured: From 0 to week 4
Energy utilization (Oxygen consumption - VO2)
Running economy during a 5-minute run at 80% of the speed at VO2max with gaz exchange analyzis
Measured: From 0 to week 8
Isokinetic neuromuscular function
peak torque in Newton per meter (N/m)
Measured: From 0 to week 8
Isometric neuromuscular function
peak torque in Newton per meter (N/m)
Measured: From 0 to week 8
Endurance capacity
Maximal oxygen consumption (VO2max) determined during graded exercise test
Measured: From 0 to week 4
Endurance capacity
Maximal oxygen consumption (VO2max) determined during graded exercise test
Measured: From 0 to week 8
Soreness and perceptual wellness
Evaluated using using a 100-point numerical pain rating scale anchored with 0= no pain to 100= the most intense pain sensation imaginable after exercise-induced muscle damage protocol
Measured: From 0 to week 4
Soreness and perceptual wellness
Evaluated using using a 100-point numerical pain rating scale anchored with 0= no pain to 100= the most intense pain sensation imaginable after exercise-induced muscle damage protocol
Measured: From 0 to week 8
Swelling - Muscle thickness (mm or cm)
Evaluated using musculoskeletal ultrasound
Measured: From 0 to week 4
Swelling - overall thigh circumference (mm or cm)
Evaluated using musculoskeletal ultrasound
Measured: From 0 to week 4
Creatine kinase (UI/I)
Blood marker analyzis
Measured: After 4 weeks of supplementation
lactate dehydrogenase (U/L)
Blood marker analyzis
Measured: After 4 weeks of supplementation
Myoglobin (ug/l)
Blood marker analyzis
Measured: After 4 weeks of supplementation
Interleukin-6 (pg/ml)
Blood marker analyzis - inflammation
Measured: After 4 weeks of supplementation
Tumor necrosis factor-α (ug/ml)
Blood marker analyzis - inflammation
Measured: After 4 weeks of supplementation
C-reactive protein (mg/l)
Blood marker analyzis - inflammation
Measured: After 4 weeks of supplementation
Isometric Neuromuscular function
Peak torque in Newton per meter (N/m)
Measured: From 0 to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start10 Jan 2023
- Primary completion1 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microphyt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Central Florida
- Responsible party
- Sponsor
- Investigators
- David Fukuda, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760742
- Sponsor's protocol ID
- STUDY00004940
- Acronym
- PORPHY-ONE
- Status last verified
- Sep 2023
- First submitted
- 23 Feb 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Protective Effects of a Novel Dietary Microalgae Supplement (PeLiv) Following Exercise-induced Muscle Damage and Influence on Endurance Capacity After Prolonged Consumption
- ClinicalTrials.gov ID
- NCT05760742
- Acronym / sponsor ID
- PORPHY-ONE / STUDY00004940
- Conditions
- Healthy
- Keywords
- recovery, muscle endurance, exercise capacity, microalgae, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- MicrophytIndustry (pharma, biotech, devices)
- Collaborators
- University of Central Florida
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 8 Mar 2023 (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.
The purpose of this investigation is to examine the effects of consuming a new dietary microalgae based supplement vs. placebo on neuromuscular function, energy utilization, soreness, perceptual wellness, swelling, and markers of muscle damage and inflammation in healthy young men before and after an acute exercise-induced muscle damage protocol (downhill running), and influence on endurance capacity after prolonged consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: Placebo2 capsules of Maltodextrin per day |
| MicAlgae100 | Experimental | Dietary Supplement: MicAlgae2 capsules per day containing 100mg of microalgae based ingredient |
| MicAlgae250 | Experimental | Dietary Supplement: MicAlgae2 capsules per day containing 250mg of microalgae based ingredient |
| MicAlgae500 | Experimental | Dietary Supplement: MicAlgae2 capsules per day containing 500mg of microalgae based ingredient |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male participants
- Healthy as assessed by Medical and activity history questionnaire (MHQ)
- Recreationally active according to American College of Sports Medicine guidelines
- Able to provide written and dated informed consent to participate in the study
Key exclusion criteria (3 listed)
- Untrained
- Any response of "yes" on the PAR-Q+
- Physical limitations preventing running, countermovement jump, and strength (peak isometric torque and peak isokinetic torque) assessments
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 |
|---|---|---|
| MicAlgae2 months of supplementation with an innovative microalgae based ingredient | Dietary supplement | MicAlgae100, MicAlgae250, MicAlgae500 |
| Placebo2 months of supplementation with a placebo (Maltodextrin) | Dietary supplement | Placebo group |
Primary outcome
Neuromuscular function
Time frame: From 0 to week 4
isokinetic peak torque in Newton per meter (N/m)
17 secondary outcomes
Energy utilization (Oxygen consumption - VO2)
Time frame: From 0 to week 4
Energy utilization (Oxygen consumption - VO2)
Time frame: From 0 to week 8
Isokinetic neuromuscular function
Time frame: From 0 to week 8
Isometric neuromuscular function
Time frame: From 0 to week 8
Endurance capacity
Time frame: From 0 to week 4
Endurance capacity
Time frame: From 0 to week 8
Soreness and perceptual wellness
Time frame: From 0 to week 4
Soreness and perceptual wellness
Time frame: From 0 to week 8
Swelling - Muscle thickness (mm or cm)
Time frame: From 0 to week 4
Swelling - overall thigh circumference (mm or cm)
Time frame: From 0 to week 4
Creatine kinase (UI/I)
Time frame: After 4 weeks of supplementation
lactate dehydrogenase (U/L)
Time frame: After 4 weeks of supplementation
Myoglobin (ug/l)
Time frame: After 4 weeks of supplementation
Interleukin-6 (pg/ml)
Time frame: After 4 weeks of supplementation
Tumor necrosis factor-α (ug/ml)
Time frame: After 4 weeks of supplementation
C-reactive protein (mg/l)
Time frame: After 4 weeks of supplementation
Isometric Neuromuscular function
Time frame: From 0 to week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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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.
David Fukuda, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MicAlgae in people with Healthy, run by Microphyt at 1 site in United States.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 22 Sep 2023. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuromuscular function (time frame: From 0 to week 4). 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 22 Sep 2023.