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

Healthy Clinical Trial

— PORPHY-ONE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05760742
• Other study ID #: STUDY00004940
• Status: Completed
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: August 18, 2023

Study information

• Verified date: September 2023
• Source: Microphyt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 exercise-induced muscle damage protocol (downhill running), and influence on endurance capacity after prolonged consumption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 18, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• MicAlgae
2 months of supplementation with an innovative microalgae based ingredient
• Placebo
2 months of supplementation with a placebo (Maltodextrin)

Locations

Country	Name	City	State
United States	University of Central Florida	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Microphyt	University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuromuscular function	isokinetic peak torque in Newton per meter (N/m)	From 0 to week 4
Secondary	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
Secondary	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
Secondary	Isokinetic neuromuscular function	peak torque in Newton per meter (N/m)	From 0 to week 8
Secondary	Isometric neuromuscular function	peak torque in Newton per meter (N/m)	From 0 to week 8
Secondary	Endurance capacity	Maximal oxygen consumption (VO2max) determined during graded exercise test	From 0 to week 4
Secondary	Endurance capacity	Maximal oxygen consumption (VO2max) determined during graded exercise test	From 0 to week 8
Secondary	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
Secondary	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
Secondary	Swelling - Muscle thickness (mm or cm)	Evaluated using musculoskeletal ultrasound	From 0 to week 4
Secondary	Swelling - overall thigh circumference (mm or cm)	Evaluated using musculoskeletal ultrasound	From 0 to week 4
Secondary	Creatine kinase (UI/I)	Blood marker analyzis	After 4 weeks of supplementation
Secondary	lactate dehydrogenase (U/L)	Blood marker analyzis	After 4 weeks of supplementation
Secondary	Myoglobin (ug/l)	Blood marker analyzis	After 4 weeks of supplementation
Secondary	Interleukin-6 (pg/ml)	Blood marker analyzis - inflammation	After 4 weeks of supplementation
Secondary	Tumor necrosis factor-a (ug/ml)	Blood marker analyzis - inflammation	After 4 weeks of supplementation
Secondary	C-reactive protein (mg/l)	Blood marker analyzis - inflammation	After 4 weeks of supplementation
Secondary	Isometric Neuromuscular function	Peak torque in Newton per meter (N/m)	From 0 to week 4