Evaluation of the Effects of a Novel Dietary Microalgae Based Ingredient on Muscle Recovery and Endurance Capacity (PORPHY-ONE)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: MicAlgae

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816
      • University of Central Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; 2 capsules of Maltodextrin per day	Dietary supplement: Placebo; 2 months of supplementation with a placebo (Maltodextrin)
Experimental: MicAlgae100; 2 capsules per day containing 100mg of microalgae based ingredient	Dietary supplement: MicAlgae; 2 months of supplementation with an innovative microalgae based ingredient
Experimental: MicAlgae250; 2 capsules per day containing 250mg of microalgae based ingredient	Dietary supplement: MicAlgae; 2 months of supplementation with an innovative microalgae based ingredient
Experimental: MicAlgae500; 2 capsules per day containing 500mg of microalgae based ingredient	Dietary supplement: MicAlgae; 2 months of supplementation with an innovative microalgae based ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuromuscular function	isokinetic peak torque in Newton per meter (N/m)	From 0 to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy utilization (Oxygen consumption - VO2)	Running economy during a 5-minute run at 80% of the speed at VO2max with gaz exchange analyzis	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	From 0 to week 8
Isokinetic neuromuscular function	peak torque in Newton per meter (N/m)	From 0 to week 8
Isometric neuromuscular function	peak torque in Newton per meter (N/m)	From 0 to week 8
Endurance capacity	Maximal oxygen consumption (VO2max) determined during graded exercise test	From 0 to week 4
Endurance capacity	Maximal oxygen consumption (VO2max) determined during graded exercise test	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	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	From 0 to week 8
Swelling - Muscle thickness (mm or cm)	Evaluated using musculoskeletal ultrasound	From 0 to week 4
Swelling - overall thigh circumference (mm or cm)	Evaluated using musculoskeletal ultrasound	From 0 to week 4
Creatine kinase (UI/I)	Blood marker analyzis	After 4 weeks of supplementation
lactate dehydrogenase (U/L)	Blood marker analyzis	After 4 weeks of supplementation
Myoglobin (ug/l)	Blood marker analyzis	After 4 weeks of supplementation
Interleukin-6 (pg/ml)	Blood marker analyzis - inflammation	After 4 weeks of supplementation
Tumor necrosis factor-α (ug/ml)	Blood marker analyzis - inflammation	After 4 weeks of supplementation
C-reactive protein (mg/l)	Blood marker analyzis - inflammation	After 4 weeks of supplementation
Isometric Neuromuscular function	Peak torque in Newton per meter (N/m)	From 0 to week 4

Collaborators and Investigators

• Sponsor: Microphyt
• Collaborators: University of Central Florida
• Investigators: Principal Investigator: David Fukuda, PhD, University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 18, 2023

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: exercise capacity; recovery; inflammation; muscle endurance; microalgae
• Other Study ID Numbers: STUDY00004940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No