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Completed

NCT Number: NCT05760742

Evaluation of the Effects of a Novel Dietary Microalgae Based Ingredient on Muscle Recovery and Endurance Capacity

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.

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Key information

Conditions

Healthy Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Florida

Orlando, Florida, 32816, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MicAlgae

Dietary Supplement

2 months of supplementation with an innovative microalgae based ingredient

Placebo

Dietary Supplement

2 months of supplementation with a placebo (Maltodextrin)

Primary outcomes

  1. Neuromuscular function

    Time frame: From 0 to week 4

    isokinetic peak torque in Newton per meter (N/m)

Secondary outcomes

  1. Energy utilization (Oxygen consumption - VO2)

    Time frame: From 0 to week 4

    Running economy during a 5-minute run at 80% of the speed at VO2max with gaz exchange analyzis

  2. Energy utilization (Oxygen consumption - VO2)

    Time frame: From 0 to week 8

    Running economy during a 5-minute run at 80% of the speed at VO2max with gaz exchange analyzis

  3. Isokinetic neuromuscular function

    Time frame: From 0 to week 8

    peak torque in Newton per meter (N/m)

  4. Isometric neuromuscular function

    Time frame: From 0 to week 8

    peak torque in Newton per meter (N/m)

  5. Endurance capacity

    Time frame: From 0 to week 4

    Maximal oxygen consumption (VO2max) determined during graded exercise test

  6. Endurance capacity

    Time frame: From 0 to week 8

    Maximal oxygen consumption (VO2max) determined during graded exercise test

  7. Soreness and perceptual wellness

    Time frame: From 0 to week 4

    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

  8. Soreness and perceptual wellness

    Time frame: From 0 to week 8

    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

  9. Swelling - Muscle thickness (mm or cm)

    Time frame: From 0 to week 4

    Evaluated using musculoskeletal ultrasound

  10. Swelling - overall thigh circumference (mm or cm)

    Time frame: From 0 to week 4

    Evaluated using musculoskeletal ultrasound

  11. Creatine kinase (UI/I)

    Time frame: After 4 weeks of supplementation

    Blood marker analyzis

  12. lactate dehydrogenase (U/L)

    Time frame: After 4 weeks of supplementation

    Blood marker analyzis

  13. Myoglobin (ug/l)

    Time frame: After 4 weeks of supplementation

    Blood marker analyzis

  14. Interleukin-6 (pg/ml)

    Time frame: After 4 weeks of supplementation

    Blood marker analyzis - inflammation

  15. Tumor necrosis factor-α (ug/ml)

    Time frame: After 4 weeks of supplementation

    Blood marker analyzis - inflammation

  16. C-reactive protein (mg/l)

    Time frame: After 4 weeks of supplementation

    Blood marker analyzis - inflammation

  17. Isometric Neuromuscular function

    Time frame: From 0 to week 4

    Peak torque in Newton per meter (N/m)

Sponsors and collaborators

Lead sponsor

Microphyt

Industry

Collaborators

  • University of Central Florida

Registry information

Official study 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

Acronym: PORPHY-ONE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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